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Melatonin

N-Acetyl-5-methoxytryptamine · Circadin

Metabolic & Circadian HormonesApproved
MW
232.28g/mol
Formula
C13H16N2O2

Melatonin, chemically known as N-acetyl-5-methoxytryptamine, is an indolamine hormone primarily produced by the pineal gland and synthesized locally in the retina, following a circadian rhythm with elevated levels at night. Researchers primarily study melatonin for its role in regulating sleep and circadian rhythms, as well as its potential therapeutic effects in various disorders. Key findings indicate that melatonin functions as a potent antioxidant and anti-inflammatory agent, particularly during pregnancy, where it helps maintain placental integrity and immune homeostasis. Additionally, studies suggest that melatonin may positively influence growth hormone levels and has been explored for its therapeutic potential in sleep disorders and mood regulation. Current research continues to investigate melatonin's multifaceted roles and its clinical relevance, particularly in developing novel therapeutic agents targeting its receptors.

Overview

Übersicht

Melatonin, also known as N-acetyl-5-methoxytryptamine or Circadin, is an endogenous hormone primarily produced by the pineal gland and also synthesized locally in the retina. It belongs to the class of indolamine hormones and is released in response to the circadian rhythm, with higher levels at night. Melatonin is also available as a synthetic supplement used in various therapeutic contexts. Researchers have observed that melatonin plays a crucial role in regulating sleep and circadian rhythms, acting as an antioxidant and anti-inflammatory agent, particularly in the placenta during pregnancy. It is involved in reducing oxidative stress and maintaining immune homeostasis, which is essential for a stable gestational environment. Melatonin exerts its effects primarily through the activation of MT1 and MT2 G protein-coupled receptors, which are involved in sleep regulation, mood disorders, and neuroprotection. These receptors have been targets for developing melatonin agonists to treat insomnia and other circadian rhythm disorders. The pharmacokinetic properties of melatonin include a short circulating half-life and metabolism primarily in the liver. Oral bioavailability is limited due to first-pass metabolism. Clinically, melatonin is used as an alternative treatment for sleep disorders, offering fewer side effects compared to traditional pharmaceuticals. In the USA, melatonin is available over-the-counter as a dietary supplement, while its regulatory status varies in other countries.

Chemical profile

Chemische Struktur

Chemical structure of Melatonin
FormelC13H16N2O2
Molekulargewicht232.28g/mol
CAS-Nummer73-31-4
PubChem CID896
Mechanism

Wirkmechanismus

Melatonin acts on MT1 and MT2 receptors, which are G protein-coupled receptors. Activation of these receptors influences sleep regulation, circadian rhythms, and various neuroprotective pathways, contributing to its therapeutic effects in sleep and mood disorders.

Mechanism

Signalweg

Melatonin primarily exerts its effects through the activation of two high-affinity G protein-coupled receptors, MT1 and MT2, which are involved in various signaling pathways, including the inhibition of adenylate cyclase and modulation of intracellular calcium levels. This receptor activation influences biological processes such as circadian rhythm regulation, sleep onset and maintenance, and anti-inflammatory responses, particularly in the placenta during pregnancy. While the precise mechanisms of action are still being elucidated, melatonin's role as an antioxidant and its effects on the growth hormone/IGF-1 axis suggest complex interactions within neuroendocrine signaling pathways.

Half-Life & Pharmacokinetics

ENEndogenous

Circulating half-life ~20-50 minutes

POOral

Poor bioavailability due to first-pass metabolism

Melatonin has a short half-life, and its bioavailability is affected by the route of administration.

Storage

Temperature

Store at room temperature (15-30C)

Light

Protect from light

Form

Stable in tablet form for extended periods

Notes

Avoid exposure to excessive heat and moisture.

Solubility

Löslichkeit

Melatonin is poorly soluble in water but soluble in ethanol and other organic solvents.

Legal Status

🇩🇪DE

In Germany, melatonin is available by prescription (verschreibungspflichtig) for certain formulations.

🇺🇸US

In the USA, melatonin is available over-the-counter as a dietary supplement and is not scheduled by the DEA.

🇦🇺AU

In Australia, melatonin is classified as a Schedule 4 (S4) prescription-only medicine.

🇬🇧UK

In the UK, melatonin is available by prescription and classified as a Prescription Only Medicine (POM) for certain uses.

Legal status information is provided for general reference only and may not reflect the most current regulatory changes. Always verify with official government sources before making any decisions.

Open Questions

Offene Forschungsfragen

Current evidence is limited regarding the long-term effects of melatonin supplementation on various populations, particularly in pregnant women and individuals with chronic sleep disorders. Further research is needed to clarify the specific mechanisms by which melatonin receptors MT1 and MT2 mediate therapeutic effects, as well as to investigate the potential interactions of melatonin with other hormones in diverse demographic groups through larger randomized controlled trials. Additionally, more studies are required to explore the optimal dosing strategies and timing for melatonin administration to maximize its benefits while minimizing any adverse effects.

176 Research Publications

12,696

Total Citations

31

Human/RCT

4.1

Avg. Influence

2024

Latest

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#01

Melatonin: a well-documented antioxidant with conditional pro-oxidant actions.

ReviewInfluence26.0
762
#02

Melatonin: a multitasking molecule.

ReviewInfluence19.0
611
The review noted that melatonin's diverse mechanisms of action contribute to improved cellular physiology, indicating its potential applications in both human and veterinary medicine.
#03

MT1 and MT2 Melatonin Receptors: A Therapeutic Perspective.

Liu Jiabei, et al. · Annual review of pharmacology and toxicology · 2016

ReviewInfluence22.0
604
The study demonstrated that selective melatonin receptor agonists targeting MT1 and MT2 may offer therapeutic benefits for sleep disorders, mood disorders, and cancer.

Key findings

  1. 01Melatonin levels vary throughout the day, being higher at night.
  2. 02MT1 and MT2 receptors play a crucial role in sleep and mood regulation.
  3. 03New melatonin-based medications are being developed to enhance treatment effectiveness.
#04

Melatonin mitigates mitochondrial malfunction.

ReviewInfluence10.0
545
The review indicated that melatonin protects against mitochondrial dysfunction and apoptosis in various disorders, improving mitochondrial respiration and ATP synthesis.
#05

Melatonin and its relation to the immune system and inflammation.

ReviewInfluence12.0
479
#06

Melatonin biosynthesis in plants: multiple pathways catalyze tryptophan to melatonin in the cytoplasm or chloroplasts.

ReviewInfluence30.0
450
Researchers observed that multiple biosynthetic pathways exist for melatonin production in plants, indicating complex regulatory mechanisms that could enhance agricultural applications.
#07

A review of sleep disorders and melatonin.

Xie Zizhen, et al. · Neurological research · 2017

ReviewInfluence12.0
358
Researchers observed that melatonin supplementation improves sleep quality and duration in individuals with sleep disorders, offering a safer alternative to traditional medications.

Key findings

  1. 01Melatonin is well tolerated and has no significant short- or long-term side effects.
  2. 02It helps synchronize circadian rhythms and improves sleep onset and quality.
  3. 03Melatonin may serve as a safer alternative to traditional sleep medications.
#08

Phytomelatonin: a review.

ReviewInfluence9.0
341
Researchers observed that melatonin functions as an antioxidant and growth promoter in plants, suggesting its role in photoperiodic responses and stress defense.
#09

Melatonin: Current Status and Future Perspectives in Plant Science.

ReviewInfluence8.0
329
The review summarized that melatonin has diverse roles in plant physiology, including enhancing growth, development, and resistance to stress.
#10

Melatonin as a radioprotective agent: a review.

ReviewInfluence13.0
320
The study demonstrated that melatonin protects mammalian cells from ionizing radiation damage through its radical scavenging ability, supporting its use as a radioprotective agent.

Clinical Trials (186)

Preclinical
Phase I
Phase II
Phase III
Approved

186

Total Trials

19,429

Total Enrolled

Sedation and Nursing Management in EEG Recording in Children

NCT05492812COMPLETED
Sponsor

Suleyman Demirel University

Enrollment

180

Started

2021

Primary outcome

Success in falling asleep

ElectroencephalographyMelatoninChloral HydrateHydroxyzineSleep Deprivation

Melatonin Plus Aminoacids for Sarcopenic Elderly

NCT03784495COMPLETED
Sponsor

Azienda di Servizi alla Persona di Pavia

Enrollment

159

Started

2014

Primary outcome

Change in Total Fat Mass and Total Free Fat Mass (DXA)

Sarcopenia

Randomized Trial Investigating Melatonin Supplementation vs Placebo on Sleep Disturbance Following Total Joint Arthroplasty

Sponsor

Rothman Institute Orthopaedics

Enrollment

154

Started

2018

Primary outcome

Patient Sleep Quality

Sleep DisturbanceTotal Joint Arthroplasty

Efficacy of the Administration of Melatonin 5mg in the Prevention of Delirium in Older Adults Hospitalized in the Emergency Department

Sponsor

Universidad Autonoma de San Luis Potosí

Enrollment

145

Started

2019

Primary outcome

Delirium

Delirium in Old Age

Effect of Oral Melatonin Versus Intraoperative Lidocaine Infusion on Incidence of Postoperative Delirium in Elderly Patients Undergoing Total Hip Arthroplasty

NCT06768580RECRUITING
Sponsor

Tanta University

Enrollment

135

Started

2025

Primary outcome

The incidence of postoperative delirium (POD)

Oral MelatoninLidocaine InfusionPostoperative DeliriumElderly PatientsTotal Hip Arthroplasty

Melatonin Treatment for Tardive Dyskinesia in Schizophrenia

NCT01391390COMPLETED
Sponsor

Beijing HuiLongGuan Hospital

Enrollment

120

Started

2008

Primary outcome

the Abnormal Involuntary Movement Scale (AIMS)

Tardive Dyskinesia

Treatment of Osteopenia With Melatonin

NCT01690000COMPLETED
Sponsor

University of Aarhus

Enrollment

81

Started

2012

Primary outcome

Changes in Bone Mineral Density (BMD)

Osteoporosis

Melatonin Supplementation in Ovarian Response

NCT07343947COMPLETED
Sponsor

University of Sao Paulo General Hospital

Enrollment

80

Started

2022

Primary outcome

Follicular fluid melatonin concentration

InfertilityInfertility (IVF Patients)Infertile Women Undergoing IVF or ICSI

Melatonin Effects on the Left Ventricular Function in Neonates With Persistent Pulmonary Hypertension

NCT07090720COMPLETED
Sponsor

Tanta University

Enrollment

80

Started

2023

Primary outcome

Left ventricle global longitudinal strain

MelatoninLeft Ventricular FunctionNeonatesPersistent Pulmonary Hypertension

The Premedication Properties of Oral Melatonin in Pediatrics Undergoing Therapeutic Cardiac Catheterization

Sponsor

Al-Azhar University

Enrollment

80

Started

2023

Primary outcome

preoperative anxiety

Anesthesia

Transdermal Fentanyl and Melatonin Patches for Postoperative Pain Relief

NCT02726126COMPLETED
Sponsor

Ain Shams University

Enrollment

75

Started

2013

Primary outcome

A mean difference of total analgesic (pethidine) consumption.

Postoperative Pain

Melatonin and Its Effect on the Perioperative Opioid Needs in Pediatric Patients Undergoing Laparoscopic Surgery.

Sponsor

Ain Shams University

Enrollment

72

Started

2023

Primary outcome

Postoperative pain

Postoperative Pain

Melatonin vs Gabapentin for Post Trauma Surgery

Sponsor

All India Institute of Medical Sciences

Enrollment

70

Started

2023

Primary outcome

preoperative anxiety

Anxiety, Preoperarative

Analgesic Effect of Melatonin and Vitamin C Administration, Alone or In Combination in Major Abdominal Surgery.

Sponsor

Cairo University

Enrollment

60

Started

2024

Primary outcome

Total morphine consumption

Postoperative Pain

A Comparison Between Oral Melatonin With Nasal Sevoflurane Versus Oral Chloral Hydrate With Nasal Sevoflurane in Sedation of Children Undergoing Brain MRI

NCT06606899COMPLETED
Sponsor

Ain Shams University

Enrollment

60

Started

2024

Primary outcome

Ramsey sedation scale recorded before starting the MRI exam.Ramsey sedation scale is a 6-point scoring system used to assess a patient's level of arousal and sedation. The scores range from 1 (anxious and agitated) to 6 (unresponsive to pain).

Sedation for Children Undergoing MRI

Comparative Efficacy of Magnesium Supplement and Melatonin Congener in Young Adults With Primary Insomnia

NCT06996171RECRUITING
Sponsor

CMH Kharian Medical College

Enrollment

60

Started

2025

Primary outcome

Insomnia Severity Index (ISI)

Primary Insomnia

Melatonin on Post Operative Pain After CS

NCT07380568COMPLETED
Sponsor

Benha University

Enrollment

60

Started

2025

Primary outcome

Postoperative pain intensity measured using the VAS (Visual Analogue Scale)

Pain ManagementPain After SurgeryCesarean Section Pain

Melatonin for Circadian Sleep Disorders in the Blind

NCT00911053TERMINATED
Sponsor

Oregon Health and Science University

Enrollment

59

Started

1997

Primary outcome

Treatment Effects on Circadian Phase Will be Assessed During Each Trial by Measuring the Timing of Endogenous Melatonin Secretion.

InsomniaBlindnessDaytime Sleepiness

Oral Melatonin With Intra Articular Analgesia on Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction

NCT07096635NOT_YET_RECRUITING
Sponsor

Assiut University

Enrollment

50

Started

2025

Primary outcome

Time to first analgesic requirement

Pain Relief After Arthroscopic Anterior Cruciate Ligament Reconstruction

Melatonin Versus Hydroxizin for Pre Operative Anxiety in Elderly Patients With Hip Fracture

Sponsor

Mongi Slim Hospital

Enrollment

50

Started

2022

Primary outcome

preoperative anxiety

Preoperative Anxiety

Effect of 1% Melatonin Gel Versus Calcium Hydroxide as an Intracanal Medicament on the Intensity of Postoperative Pain, Bacterial Load Reduction and Periapical MMP-9 Levels in Patients With Necrotic Pulp.

NCT07495605NOT_YET_RECRUITING
Sponsor

Cairo University

Enrollment

50

Started

2026

Primary outcome

Intensity of postoperative pain

Intensity of Postoperative Pain, Bacterial Load Reduction and Periapical MMP-9 Levels in Patients With Necrotic Pulp

Clinical Trial for the Evaluation of Melatonin in the Treatment of Pressure Ulcers

Sponsor

Fundacion Rioja Salud

Enrollment

50

Started

2024

Primary outcome

Epithelialisation

Pressure Ulcer

Effectiveness of Combining Light and Non-Light Treatments for Jet Lag and Sleep Disorders

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Enrollment

48

Started

2006

Primary outcome

Circadian phase, as measured by the shift of the endogenous melatonin rhythm (measured during each inpatient visit)

Sleep Disorders, Circadian Rhythm

Comparative Evaluation of Melatonin Versus MTA on Vital Pulp Therapy in Young Permanent First Molars: An in Vivo Study

NCT06372561RECRUITING
Sponsor

Suez Canal University

Enrollment

45

Started

2023

Primary outcome

Clinically assessment (Modified visual analogue scale)

Dental Caries in ChildrenVital Pulp Therapy

Melatonin Treatment and Inflammation, Oxidative Stress and Autonomic Function in Connection With Surgery

Sponsor

University Hospital, Gentofte, Copenhagen

Enrollment

40

Started

2006

Oxidative StressInflammatory StressMyocardial Ischaemia

Improving Sleep of Children With Neurodevelopmental Disorders: Pulsed Current Stimulation Versus Melatonin

Sponsor

KK Women's and Children's Hospital

Enrollment

40

Started

2023

Primary outcome

Total sleep time (TST)

InsomniaNeurodevelopmental Disorders

Effects of Melatonin in PCOS Women

Sponsor

Catholic University of the Sacred Heart

Enrollment

40

Started

2015

Primary outcome

Number of cycles in six months of therapy

Polycystic Ovary Syndrome

The Efficacy of Oral Melatonin in Preventing Postoperative Delirium for Patients Undergoing Orthopedic Surgery Under General Anesthesia

NCT05236907COMPLETED
Sponsor

University of Baghdad

Enrollment

36

Started

2020

Primary outcome

The efficacy of oral Melatonin in preventing Postoperative Delirium after general anesthesia

Delirium, Anesthesia EmergenceDelirium

The Effect of Melatonin on Gene Expression and Activity of the Sirt1 and Its Target Genes Catalase and MnSOD in Multiple Sclerosis Patients and Healthy Subjects

NCT02463318COMPLETED
Sponsor

Tehran University of Medical Sciences

Enrollment

34

Started

2012

Primary outcome

Relative gene expression by real-time PCR (polymerase chain reaction)

Multiple SclerosisOxidative Stress

Efficacy and Safety of Melatonin and Clonazepam for IRBD

NCT03255642COMPLETED
Sponsor

Kyung Hee University Hospital at Gangdong

Enrollment

34

Started

2017

Primary outcome

Automated REM without atonia index

REM Sleep Behavior Disorder

Melatonin on Anxiety and Sleep Quality in Adults Undergoing Coronary Artery Bypass Graft Surgery

Sponsor

Ain Shams University

Enrollment

30

Started

2024

Primary outcome

Quality of sleep

MelatoninAnxietySleep QualityCoronary Artery Bypass Graft

Melatonin vs Metoprolol or Dexmedetomidine to Improve Surgical Field in FESS

NCT07568873COMPLETED
Sponsor

Zagazig University

Enrollment

28

Started

2024

Primary outcome

Assessment of change in the mean arterial pressure measured in mmHg.

Stress Response of Endotracheal Intubation and Surgical Field Clarity in FESS

Effects of Melatonin and Oxygen Consumption and Choroidal Blood Flow

NCT00675181COMPLETED
Sponsor

University Hospital, Basel, Switzerland

Enrollment

16

Started

2008

Primary outcome

-choroidal blood flow -oxygen consumption -Co2 production -skin temperatures -rectal temperatures -blood pressure -eye tension

Vasospastic Syndrome

Blind Elderly Melatonin Treatment Study

NCT00692094TERMINATED
Sponsor

Oregon Health and Science University

Enrollment

12

Started

2004

Primary outcome

Circadian Phase Marker, as Measured by the Melatonin Levels in Serial Salivary and/or Plasma Samples.

Blindness

Melatonin in Adults With SMS

NCT03492970COMPLETED
Sponsor

Hôpital le Vinatier

Enrollment

10

Started

2018

Primary outcome

24h melatonin levels

Smith Magenis Syndrome

Blind Child Melatonin Treatment Study

NCT00691444TERMINATED
Sponsor

Oregon Health and Science University

Enrollment

10

Started

2002

Primary outcome

Circadian Phase Marker, as Measured by the Melatonin Levels in Serial Salivary and/or Plasma Samples.

Blindness

Exogenous Melatonin in Postmenopausal Women with Insomnia

NCT05440734TERMINATED
Sponsor

Douglas Mental Health University Institute

Enrollment

6

Started

2022

Primary outcome

Change in sleep duration

Insomnia

Melatonin Use in the Intensive Care Elderly Population

NCT03013790Phase 4UNKNOWN
Sponsor

MICE Trial Group

Enrollment

600

Started

2016

Primary outcome

Delirium

DeliriumMelatonin

Comparison Of The Effects Of Melatonin Premedication And Ketamine On Postoperative Sleep Quality İn Rhinoplasty

NCT06898463Phase 4COMPLETED
Sponsor

Konya City Hospital

Enrollment

183

Started

2022

Primary outcome

To compare the effects of melatonin and ketamine on postoperative sleep disturbances.

Postoperative Sleep Disturbances

Emergence Agitation After Nasal Surgery: a Randomized Controlled Comparison Between Melatonin and Mirtazapine

NCT04908605Phase 4COMPLETED
Sponsor

Ain Shams University

Enrollment

165

Started

2021

Primary outcome

Total number of patients with the Riker sedation-agitation score ≥5

Agitation

Optimal Dosage of Melatonin for Preoperative Sedation in FESS

NCT07550751Phase 4COMPLETED
Sponsor

Aswan University Hospital

Enrollment

160

Started

2024

Primary outcome

preoperative sedation using ramsay sedation scale

Clinical Trial

Oral Bedtime Melatonin in Critically Ill Patients

NCT06156059Phase 4UNKNOWN
Sponsor

Hospital San Carlos, Madrid

Enrollment

160

Started

2025

Primary outcome

Mortality at 90 days

Septic ShockStroke HemorrhagicStrokes ThromboticCardiac Arrest

The Effect of Dexmedetomidine Infusion Alone Versus the Combination of Dexmedetomidine and Melatonin on Reduction of Post-operative Delirium (POD) After Open Brain Surgeries

NCT07475156Phase 4COMPLETED
Sponsor

Ain Shams University

Enrollment

100

Started

2025

Primary outcome

The incidence of POD

Post Operative Delerium

Efficacy of Melatonin Treatment on Sleep Quality Improvement in Inflammatory Bowel Disease Patients With Clinical Remission

NCT07737665Phase 4RECRUITING
Sponsor

Mahidol University

Enrollment

90

Started

2025

Primary outcome

PSQI (Pittsburgh Sleep Quality Index) score at 12th week of study

IBD (Inflammatory Bowel Disease)

Premedication With Melatonin and Alprazolam Combination Versus Alprazolam or Melatonin Alone

NCT01486615Phase 4COMPLETED
Sponsor

B.P. Koirala Institute of Health Sciences

Enrollment

80

Started

2011

Primary outcome

Change in VAS Anxiety Score Relative to Baseline After Premedication

Anxiety

Melatonin vs Pregabalin for Anxiolysis and Sedation

NCT05221151Phase 4COMPLETED
Sponsor

Menoufia University

Enrollment

78

Started

2022

Primary outcome

VAS

Anxiety

Melatonin on Coronary Artery Calcification

NCT03966235Phase 4UNKNOWN
Sponsor

Chinese PLA General Hospital

Enrollment

74

Started

2019

Primary outcome

a change in CAC score at 6 months measured by coronary CTA

Coronary Artery Calcification

Melatonin in Smoke-induced Vascular Injury

NCT02591238Phase 4COMPLETED
Sponsor

Peking Union Medical College Hospital

Enrollment

68

Started

2015

Primary outcome

Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of Fbg.

SmokingVascular System Injuries

The Use of Sublingual Melatonin Premedication in Geriatric Cataract Surgery

NCT07036367Phase 4RECRUITING
Sponsor

Al-Azhar University

Enrollment

60

Started

2025

Primary outcome

perioperative anxiety

Cataract Surgery Anesthesia

The Effects of Melatonin on Elevated Liver Enzymes During Statins Treatment

NCT03121521Phase 4COMPLETED
Sponsor

Medical University of Lodz

Enrollment

60

Started

2012

Primary outcome

liver enzymes

Hepatopathy

Melatonin in Patients Under Carotid Endarterectomy

NCT03115034Phase 4COMPLETED
Sponsor

Peking Union Medical College Hospital

Enrollment

60

Started

2016

Primary outcome

Melatonin effects on patients under CEA assessed by the concentration of SOD

Carotid Stenosis

Insulin Resistance in Patients After Carotid Revascularization

NCT03419767Phase 4UNKNOWN
Sponsor

Peking Union Medical College Hospital

Enrollment

60

Started

2017

Primary outcome

insulin resistance in patients under carotid revascularization assessed by the concentration of insulin

Carotid Stenosis

Comparison Between Melatonin and Diazepam for Prevention of Recurrent Simple Febrile Seizures

NCT03631901Phase 4COMPLETED
Sponsor

Tanta University

Enrollment

60

Started

2017

Primary outcome

recurrence of febrile seizures during febrile illness

Febrile Seizures

Transdermal Nicotine and Melatonin Patches for Postoperative Pain Relief

NCT02747628Phase 4COMPLETED
Sponsor

Ain Shams University

Enrollment

60

Started

2013

Primary outcome

A Mean Difference of Total Analgesic (Pethidine) Consumption.

Postoperative Pain Relief

Preoperative Melatonin or Vitamin C Administration on Postoperative Analgesia

NCT02639741Phase 4COMPLETED
Sponsor

Cukurova University

Enrollment

55

Started

2014

Primary outcome

morphine consumption at 24 hours after surgery.)

Postoperative Pain

Evaluation Efficacy of Melatonin Gel as Adjunctive Therapy in Chronic Periodontitis

NCT05759416Phase 4COMPLETED
Sponsor

Al-Azhar University

Enrollment

40

Started

2020

Primary outcome

Efficacy of Melatonin gel by determine the change on measurements of clinical parameter in chronic periodontitis.

Chronic Periodontitis

Effect of Melatonin on Sleep Quality in Patients Dementia

NCT03066518Phase 4COMPLETED
Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Enrollment

40

Started

2016

Primary outcome

Pittsburgh Sleep Quality Index

Sleep DisordersDementia

Effects of Melatonin on Sleep Architecture of Critically Ill Patients in the ICU

NCT07691996Phase 4NOT_YET_RECRUITING
Sponsor

Rutgers, The State University of New Jersey

Enrollment

30

Started

2026

Primary outcome

Sleep Efficiency as measured by total sleep time over time in bed

Critical IllnessICUICU HospitalizationMelatoninSleep

Effect of Slow-release Melatonin (Circadin®) Therapy on Idiopathic RBD: a Pilot Study

NCT02836743Phase 4UNKNOWN
Sponsor

Seoul National University Hospital

Enrollment

30

Started

2016

Primary outcome

Changes in Clinical Global Impression scale

REM Sleep Behavior Disorder

Investigation of Melatonin and Zolpidem Effect on Postural Instability in Healthy Adult Subjects

NCT01280734Phase 4COMPLETED
Sponsor

Neurim Pharmaceuticals Ltd.

Enrollment

26

Started

2011

Primary outcome

Body sway

Postural Instability

Assessment of Immediate Implant Stability When Adding Mixture of Hyaluronic Acid and Melatonin

NCT03692026Phase 4UNKNOWN
Sponsor

Cairo University

Enrollment

24

Started

2018

Primary outcome

Implant stability

Immediate Dental Implant

Evaluation of Melatonin Application of Immediate Dental Implant

NCT03689998Phase 4COMPLETED
Sponsor

Cairo University

Enrollment

24

Started

2019

Primary outcome

implant stability

Immediate Dental Implant

Melatonin Gel as an Adjuvant in the Surgical Management of Intrabony Defects

NCT06821425Phase 4COMPLETED
Sponsor

Ain Shams University

Enrollment

20

Started

2025

Primary outcome

- Radiographic evaluation of the changes in the intrabony defect

Periodontal Disease, AVDC Stage 3

Antiinflammatoric and Antioxidative Effect of Melatonin in Human Endotoxaemia

NCT01087359Phase 4COMPLETED
Sponsor

Herlev Hospital

Enrollment

12

Started

2010

Primary outcome

Inflammatoric markers

Human Endotoxaemia

Efficacy and Safety of Circadin® 2 mg in the Treatment of Primary Insomnia Patients

NCT00397189Phase 3COMPLETED
Sponsor

Neurim Pharmaceuticals Ltd.

Enrollment

930

Started

2006

Primary outcome

The Change From Baseline in Subjective Sleep Latency.

Primary Insomnia

MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children

NCT05541276Phase 3RECRUITING
Sponsor

Arash Afshari

Enrollment

676

Started

2025

Primary outcome

Incidence of emergence agitation

Emergence Delirium

Melatonin for Prevention of Postoperative Delirium After Lower Limb Fracture Surgery in Elderly Patients

NCT04335968Phase 3COMPLETED
Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

357

Started

2021

Primary outcome

Postoperative delirium incidence

Orthopedic Surgery

Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth Restriction

NCT05651347Phase 3RECRUITING
Sponsor

Monash University

Enrollment

336

Started

2019

Primary outcome

Neurodevelopmental performance at 2 years of life among survivors of early onset FGR.

Fetal Growth RetardationStillbirth and Fetal DeathPregnancy Preterm

Melatonin for Prevention of Kidney Injury

NCT05084196Phase 3RECRUITING
Sponsor

Rutgers, The State University of New Jersey

Enrollment

300

Started

2023

Primary outcome

Acute kidney injury

Acute Kidney InjuryAdverse Drug Event

Prevention of Delirium in Inpatients Utilizing Melatonin

NCT02654314Phase 3TERMINATED
Sponsor

Yale University

Enrollment

277

Started

2016

Primary outcome

Delirium

Delirium

Melatonin for Patients With Chronic Low Back Pain

NCT06859957Phase 3ACTIVE_NOT_RECRUITING
Sponsor

Bart Koes

Enrollment

222

Started

2025

Primary outcome

Change in low back pain intensity

Chronic Low-back Pain (cLBP)

Melatonin fOr CHronic bAck Pain (The MOCHA Trial)

NCT06476392Phase 3COMPLETED
Sponsor

Odense University Hospital

Enrollment

220

Started

2024

Primary outcome

Difference in change in average pain intensity during the last 7 days between groups

Back Pain Lower Back ChronicInsomnia

of Myo-inositol, Melatonin and Co-enzyme q10 on Ovarian Reserve

NCT06405204Phase 3UNKNOWN
Sponsor

Beni-Suef University

Enrollment

200

Started

2024

Primary outcome

pregnancy

IVF

Melatonin vs Midazolam in Children Undergoing Tonsillectomy

NCT07336095Phase 3NOT_YET_RECRUITING
Sponsor

Ain Shams University

Enrollment

195

Started

2026

Primary outcome

Incidence of preoperative anxiety with oral melatonin vs oral midazolam as a premedication in Children Undergoing Tonsillectomy.

Emergence Delirium, AnesthesiaChildAnxietyMidazolam PremedicationMelatonin BioavailabilityTonsillectomy

Clinical Trial of Antioxidant Therapy in Patients With Septic Shock

NCT03557229Phase 3UNKNOWN
Sponsor

American British Cowdray Medical Center

Enrollment

131

Started

2018

Primary outcome

Organic failure measurement by the Sequential Organ Failure Assessment Score (SOFA)

Oxidative StressSeptic Shock

Melatonin as Adjuvant Treatment for ADHD in Adults

NCT03062839Phase 3UNKNOWN
Sponsor

Hospital Israelita Albert Einstein

Enrollment

120

Started

2017

Primary outcome

Adult ADHD Investigator Symptom Rating Scale.

Attention Deficit Hyperactivity Disorder

Effect of Melatonin on Cardiometabolic Risk- FULL

NCT02681887Phase 3UNKNOWN
Sponsor

Brigham and Women's Hospital

Enrollment

120

Started

2016

Primary outcome

change in insulin sensitivity

ObesityPrediabetic State

Pediatric Prolonged-Release Melatonin for Sleep Disturbances in Children and Adolescents With Anorexia Nervosa (MELSom-ANOREXIA)

NCT07576764Phase 3NOT_YET_RECRUITING
Sponsor

Assistance Publique Hopitaux De Marseille

Enrollment

120

Started

2026

Primary outcome

Change from baseline in mean Total Sleep Time (TST) measured by Sleep Diary

Anorexia NervosaSleep Disorders in Children

Cerebroprotective Effect of Melatonin in Stroke

NCT05857046Phase 3UNKNOWN
Sponsor

Coordinación de Investigación en Salud, Mexico

Enrollment

100

Started

2024

Primary outcome

Change in functional outcome and mortality

Stroke, Acute IschemicStrokes Thrombotic

The Contribution of Melatonin Vs. Placebo in Benzodiazepine Withdrawal in Methadone Maintenance Treatment Patients

NCT00261183Phase 3UNKNOWN
Sponsor

Tel-Aviv Sourasky Medical Center

Enrollment

100

Started

2004

Primary outcome

Stop benzodiazepine abuse(Urine)

Benzodiazepines

Adjuvant Melatonin for Uveal Melanoma

NCT05502900Phase 3RECRUITING
Sponsor

Gustav Stalhammar

Enrollment

100

Started

2022

Primary outcome

Number of patients that develop metastases in Melatonin vs. Control arm, evaluated as relative risk (RR).

Uveal MelanomaUveal Melanoma, Posterior, Medium/Large SizeEye Cancer, Intraocular Melanoma

Exogenous Melatonin in Intensive Care Unit Chronodisruption

NCT03708341Phase 3UNKNOWN
Sponsor

Saint-Joseph University

Enrollment

98

Started

2018

Primary outcome

Total sleep time

Sleep DeprivationIntensive Care Psychosis

COMPARISON OF OUTCOME OF HYPOXIC ISCHEMIC ENCEPHLOPATHY MANAGED WITH COMBINATION OF MAGNESIUM SULPHATE AND MELATONIN VERSUS MAGNESIUM SULPHATE ALONE

NCT07652801Phase 3NOT_YET_RECRUITING
Sponsor

University of Child Health Sciences and Children's Hospital, Lahore

Enrollment

80

Started

2026

Primary outcome

1.Change in PH 2.Serum LDH(U/L)

HIE - Hypoxic - Ischemic Encephalopathy

Melatonin Associated to Acid Inhibition for Chemoprevention in Barret Esophagus: a Pilot Study

NCT01566474Phase 3COMPLETED
Sponsor

Aragon Institute of Health Sciences

Enrollment

80

Started

2012

Primary outcome

Oxidative stress

Barrett's Esophagus

Melatonin and Quality of Life in Dialysis Patients

NCT00388661Phase 3COMPLETED
Sponsor

Meander Medical Center

Enrollment

68

Started

2007

Primary outcome

Improvement of vitality (dimension quality of life) by 15 points (RAND SF 36)

Sleep ProblemsHaemodialysis

Melatonin Effect in Combination With Neoadjuvant Chemotherapy to Clinical Response in Locally Advanced Oral Squamous Cell Carcinoma

NCT04137627Phase 3COMPLETED
Sponsor

Indonesia University

Enrollment

50

Started

2017

Primary outcome

Clinical Response as Measured by RECIST 1.1. Criteria

Oral Squamous Cell CarcinomaNeoadjuvant Chemotherapy

Cardioprotective Effects of Melatonin in Patients With Cardiomyopathy

NCT06846086Phase 3RECRUITING
Sponsor

Tanta University

Enrollment

46

Started

2025

Primary outcome

Blood Pressure Measurement

Cardiomyopathies

The Clinical Utility of Measuring the Circadian Clock in Treatment of Delayed Sleep-Wake Phase Disorder

NCT03715465Phase 3COMPLETED
Sponsor

University of Michigan

Enrollment

44

Started

2019

Primary outcome

Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 4 Weeks

Delayed Sleep Phase Syndrome

The Efficacy of Melatonin in Sleep Problems of Hemodialysis and Peritoneal Dialysis Patients

NCT00404456Phase 3COMPLETED
Sponsor

Meander Medical Center

Enrollment

40

Started

2005

Primary outcome

Sleep onset latency < 15 minutes

HemodialysisPeritoneal DialysisSleep Problems

Melatonin for Pulmonary Hypertension in Full Term Neonates

NCT06685679Phase 3COMPLETED
Sponsor

Ain Shams University

Enrollment

40

Started

2024

Primary outcome

Pulmonary arterial pressure

Neonatal Diseases and AbnormalitiesNeonatal MortalityPulmonary Arterial HypertensionPulmonary Arterial Hypertension, Children

The Effect of Melatonin Administration on Sedation Level as Adjuvant to Propofol

NCT04034771Phase 3COMPLETED
Sponsor

Cairo University

Enrollment

38

Started

2018

Primary outcome

level of sedation

TBI (Traumatic Brain Injury)

The Effect of Melatonin Application Following Removal of Impacted Third Molar

NCT04424875Phase 3COMPLETED
Sponsor

Fayoum University

Enrollment

38

Started

2020

Primary outcome

Bone density

Impacted Third Molar Tooth

Diabetic Retinopathy: Effects of Melatonin Treatment on Visual Functions and Circadian Rhythm

NCT03478306Phase 3COMPLETED
Sponsor

Glostrup University Hospital, Copenhagen

Enrollment

31

Started

2018

Primary outcome

Progression of diabetic retinopathy, oscillary potential

Diabetic RetinopathyMelatoninCircadian DysrhythmiaCircadian Rhythm Sleep Disorder, Unspecified Type

Premedication With Melatonin in Lumbar Medial Branch Block Procedure

NCT02415309Phase 3COMPLETED
Sponsor

United States Naval Medical Center, San Diego

Enrollment

25

Started

2016

Primary outcome

Change in anxiety level scores as assessed by the data collection sheet given to patients at all three time points (listed below)

Anxiety

Efficacy of Melatonin in Decreasing the Incidence of Delirium in End of Life Patients

NCT02536417Phase 3COMPLETED
Sponsor

Fraser Health

Enrollment

19

Started

2016

Primary outcome

Development of delirium, as determined by the Confusion Assessment Method (CAM) criteria

Delirium

Effect of Topical Melatonin Application on Dental Implant Osseointegration and Marginal Bone Level

NCT04229719Phase 3UNKNOWN
Sponsor

University of Baghdad

Enrollment

10

Started

2019

Primary outcome

Measuring marginal bone level

Alveolar Bone Loss

Study of Melatonin: Sleep Problems in Alzheimer's Disease

NCT00000171Phase 3COMPLETED
Sponsor

National Institute on Aging (NIA)

Alzheimer DiseaseDyssomnias

Melatonin for Prevention of Post Stroke Delirium

NCT04122599Phase 2/3UNKNOWN
Sponsor

University Hospital Tuebingen

Enrollment

2,000

Started

2017

Primary outcome

Change of delir prevalence

Post Stroke Delirium

Efficacy of Melatonin in the Prophylaxis of Coronavirus Disease 2019 (COVID-19) Among Healthcare Workers.

NCT04353128Phase 2/3COMPLETED
Sponsor

Instituto de Investigación Hospital Universitario La Paz

Enrollment

450

Started

2020

Primary outcome

SARS-CoV 2 infection rate

Covid19SARS-CoV 2Coronavirus Infection

Prevention of Delirium in Intensive Care by Melatonin

NCT03524937Phase 2/3COMPLETED
Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

355

Started

2019

Primary outcome

Delirium incidence

Mechanically Ventilated Patients

Melatonin 3mg and 5mg Compared to Cognitive Behavioral Therapy for Insomnia (CBT-I) in the Treatment of Insomnia

NCT02798367Phase 2/3UNKNOWN
Sponsor

Ache Laboratorios Farmaceuticos S.A.

Enrollment

307

Started

2018

Primary outcome

Change of Sleep Latency after 21 (±2) days of the treatment.

Insomnia Disorder

The Effect of MElatonin on Depression, Anxiety, CIrcadian and Sleep Disturbances in Patients After Acute Myocardial Syndrome

NCT02451293Phase 2/3COMPLETED
Sponsor

Zealand University Hospital

Enrollment

252

Started

2016

Primary outcome

Major Depression Inventory (MDI)

DepressionAcute Coronary Syndrome

Pharmacological Treatment on the Recovery of Neurosensory Disturbance After Bilateral Sagittal Split Osteotomy

NCT05536596Phase 2/3UNKNOWN
Sponsor

Universitat Internacional de Catalunya

Enrollment

220

Started

2022

Primary outcome

Neurosensory Activity

RetrognathismPrognathismOrthognathic SurgeryNeurosensory Disorder

Impact of Melatonin on IVF/ICSI Outcomes in Prospective Poor Responders

NCT02993588Phase 2/3UNKNOWN
Sponsor

Assiut University

Enrollment

100

Started

2016

Primary outcome

Total number of retrieved mature oocytes

In Vitro FertilizationPoor Ovarian Response

Melatonin for Fatigue and Other Symptoms in Patients With Advanced Cancer

NCT00925899Phase 2/3COMPLETED
Sponsor

Bispebjerg Hospital

Enrollment

72

Started

2009

Primary outcome

Fatigue as Measured by the Physical Fatigue Scale in the The Multidimensional Fatigue Inventory (MFI) (Smets EM, Garssen B, Bonke B, et al., J Psychosom Res 39:315-325, 1995)

CancerFatigue

Immune-Pineal Axis Function in Fibromyalgia

NCT02041455Phase 2/3UNKNOWN
Sponsor

Hospital de Clinicas de Porto Alegre

Enrollment

66

Started

2010

Primary outcome

Change from Baseline in pain on Fibromyalgia Impact Questionnaire (FIQ) at week 6

Fibromyalgia

The Effect of Melatonin on Depression, Anxiety, Cognitive Function and Sleep Disturbances in Breast Cancer Patients

NCT01355523Phase 2/3TERMINATED
Sponsor

Melissa Voigt Hansen

Enrollment

54

Started

2011

Primary outcome

Major Depression Inventory (MDI)- Depression at One Point in the Study

Breast CancerDepression

Evaluating Efficacy and Safety of Oral Melatonin in Acute Central Serous Chorioretinopathy

NCT06809751Phase 2/3NOT_YET_RECRUITING
Sponsor

Mohsen Pourazizi

Enrollment

48

Started

2025

Primary outcome

central macular thickness (CMT)

Central Serous ChorioretinopathyMelatoninOcular DiseasesVisual AcuityMacula Abnormality

RECOVER-SLEEP: Platform Protocol

NCT06404086Phase 2COMPLETED
Sponsor

Duke University

Enrollment

830

Started

2024

Primary outcome

Total number of participants enrolled in each Appendix

Long COVIDLong COVID-19HypersomniaSleep Disturbance

The Melatonin Adjunct in the Acute myocaRdial Infarction Treated With Angioplasty

NCT00640094Phase 2TERMINATED
Sponsor

Alberto Domínguez Rodríguez

Enrollment

272

Started

2013

Primary outcome

Infarct size

Acute Myocardial Infarction

Acute Concussion and Melatonin

NCT04731974Phase 2UNKNOWN
Sponsor

Children's National Research Institute

Enrollment

254

Started

2023

Primary outcome

Comparison of average daily sleep duration between melatonin and placebo post acute pediatric concussion

Concussion, MildConcussion, BrainPediatric ALL

Melatonin and Solifenacin for Double-J Ureteral Stent Symptoms

NCT07617922Phase 2RECRUITING
Sponsor

Beni-Suef University

Enrollment

189

Started

2026

Primary outcome

Total Ureteral Stent Symptom Questionnaire Score at Postoperative Day 7

Ureteral Stent-Related SymptomsUreteral CalculiLower Urinary Tract Symptoms

Efficacy and Safety Study of a Combination Product [Drug:BCI-024 (Buspirone) and Drug:BCI-049 (Melatonin)] to Treat Major Depressive Disorder (MDD)

NCT00705003Phase 2COMPLETED
Sponsor

Massachusetts General Hospital

Enrollment

142

Started

2008

Primary outcome

The Score on the Clinical Global Impression-Improvement (CGI-I) at Week 6

Major Depressive Disorder

Effectiveness Of High Dose Melatonin As Adjunctive Therapy For Dengue Fever With Warning Signs

NCT05034809Phase 2UNKNOWN
Sponsor

Ilocos Training and Regional Medical Center

Enrollment

140

Started

2021

Primary outcome

Number Of Days Prior To Elevation of Platelet Count Among Dengue Fever with Warningn Signs Patient Given Melatonin 20mg.

Dengue Fever With Warning Signs

Melatonin for Post Operative Delirium Prevention in Elderly Patients

NCT05640934Phase 2COMPLETED
Sponsor

Menoufia University

Enrollment

100

Started

2022

Primary outcome

Incidence of delirium occurrence

Delirium in Old Age

Neoadjuvant Toremifene With Melatonin or Metformin in Locally Advanced Breast Cancer

NCT02506790Phase 2UNKNOWN
Sponsor

N.N. Petrov National Medical Research Center of Oncology

Enrollment

96

Started

2015

Primary outcome

Response rate

Breast Cancer

Melatonin for Renal Protection in Patients Receiving Polymyxin B

NCT03725267Phase 2TERMINATED
Sponsor

Hospital de Clinicas de Porto Alegre

Enrollment

88

Started

2018

Primary outcome

Acute Kidney Injury according to RIFLE criteria

Acute Kidney InjuryMelatoninPolymyxin B Adverse Reaction

CHOCOlate MeLatonin for AdolescenT MigrainE

NCT03597529Phase 2COMPLETED
Sponsor

Amy Gelfand

Enrollment

84

Started

2017

Primary outcome

Change in Mean Visual Analog Scale (VAS) Score

Migraine

Effect of Melatonin on Reduction of Pelvic Pain

NCT03782740Phase 2COMPLETED
Sponsor

Karolinska Institutet

Enrollment

80

Started

2019

Primary outcome

Pain reduction

DysmenorrheaEndometriosis

Melatonin for Adolescent Migraine Prevention Study

NCT03150797Phase 2TERMINATED
Sponsor

Amy Gelfand

Enrollment

72

Started

2017

Primary outcome

Mean Migraine/Migrainous Days in Weeks 5-8 of Randomized Treatment Phase in Melatonin Treated Participants vs. Placebo.

Migraine

Melatonin for Prevention of Delirium in Critically Ill Patients

NCT02615340Phase 2UNKNOWN
Sponsor

Mount Sinai Hospital, Canada

Enrollment

69

Started

2017

Primary outcome

Feasibility: Study adherence

Delirium

Melatonin Therapy for Improving ICSI Outcomes in Women With Diminished Ovarian Reserve

NCT07318974Phase 2ACTIVE_NOT_RECRUITING
Sponsor

Benha University

Enrollment

64

Started

2025

Primary outcome

The Success Rate of Treatment Regimens in Achieving Clinical Pregnancy

ICS

Preoperative Melatonin to Decrease Analgesia Usage After Third Molar Surgery

NCT04791943Phase 2COMPLETED
Sponsor

Montefiore Medical Center

Enrollment

60

Started

2021

Primary outcome

Postoperative narcotic consumption

Pain, PostoperativeNarcotic Use

Effects of Hydrocortisone, Melatonin, and Placebo on Jet Lag

NCT00097474Phase 2COMPLETED
Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Enrollment

57

Started

2004

Primary outcome

improvement in jet lag symptoms

Jet Lag

Neuroplasticity:Melatonin and Transcranial Current Stimulation in Healthy Subjects.

NCT02195271Phase 2UNKNOWN
Sponsor

Hospital de Clinicas de Porto Alegre

Enrollment

50

Started

2014

Primary outcome

Change from baseline in heat-pain threshold with pain score

Analgesia DisorderPain

Melatonin for Migraine Prevention

NCT00849511Phase 2COMPLETED
Sponsor

Nordlandssykehuset HF

Enrollment

48

Started

2009

Primary outcome

Migraine attack frequency

Migraine

Effect of Melatonin and Metformin on Glycemic Control Genotoxicity and Cytotoxicity Markers in Patients With Prediabetes

NCT03848533Phase 2UNKNOWN
Sponsor

University of Guadalajara

Enrollment

42

Started

2019

Primary outcome

Fasting plasma glucose (FPG)

PreDiabetes

The Effect of Melatonin on Ischemia-reperfusion Injury Following Acute Myocardial Infarction

NCT01172171Phase 2COMPLETED
Sponsor

Herlev Hospital

Enrollment

41

Started

2013

Primary outcome

MRI of the heart

Acute Myocardial InfarctionIschemia-reperfusion Injury

The Effect of Melatonin on Nocturnal Enuresis

NCT01575678Phase 2UNKNOWN
Sponsor

University of Aarhus

Enrollment

40

Started

2012

Primary outcome

number of incontinence episodes

Nocturnal Enuresis

Sleep Inducing And Maintaining Efficacy Of Circadin In Elderly Insomniacs

NCT00816673Phase 2COMPLETED
Sponsor

Neurim Pharmaceuticals Ltd.

Enrollment

40

Started

1996

Primary Insomnia

Melatonin and the Metabolic Syndrome

NCT01038921Phase 2COMPLETED
Sponsor

Emory University

Enrollment

39

Started

2009

Primary outcome

Metabolic Syndrome Components

Metabolic Syndrome

Melatonin and Nighttime Blood Pressure in African Americans-8 mg Study

NCT01114360Phase 2COMPLETED
Sponsor

Emory University

Enrollment

37

Started

2010

Primary outcome

Mean Nighttime Systolic Blood Pressure (SBP)

Hypertension

Melatonin as a Circadian Clock Regulator, Neuromodulator and Myelo-protector in Adjuvant Breast Cancer Chemotherapy

NCT03205033Phase 2COMPLETED
Sponsor

Hospital de Clinicas de Porto Alegre

Enrollment

36

Started

2016

Primary outcome

To evaluate the response to melatonin as a sleep-wake rhythm synchronizer on the effects induced by chemotherapy in women with breast cancer.

Sleep Disorders, Circadian RhythmDepressionGenotoxicityPain

Melatonin for Prevention of Metabolic Side Effects of Olanzapine

NCT01593774Phase 2COMPLETED
Sponsor

Guilan University of Medical Sciences

Enrollment

36

Started

2012

Primary outcome

Change from baseline in weight at week eight

Schizophrenia

Bringing Relief to Adolescents Naturally Using Melatonin for Migraine

NCT02344316Phase 2COMPLETED
Sponsor

Amy Gelfand

Enrollment

31

Started

2015

Primary outcome

Number of Migraine/Migrainous Days Per 28 Day Period

Migraine in Adolescents

Melatonin for Treatment of Delirium in Critically Ill Adult Patients

NCT05713877Phase 2RECRUITING
Sponsor

Ciusss de L'Est de l'Île de Montréal

Enrollment

30

Started

2023

Primary outcome

Feasibility: Enrollment rate

Delirium

Platelet Rich Fibrin Versus Melatonin Around Dental Implants

NCT05593731Phase 2COMPLETED
Sponsor

Misr University for Science and Technology

Enrollment

30

Started

2021

Primary outcome

gingival thickness

Patients With Missing Teeth

Effects of Melatonin on Insomnia Symptoms in Older Adults

NCT00230737Phase 2COMPLETED
Sponsor

Nalaka Gooneratne

Enrollment

27

Started

2004

Primary outcome

Peak Melatonin Level

Sleep Initiation and Maintenance Disorders

Does Melatonin Restore Sleep Architecture in Autistic Children

NCT01993251Phase 2COMPLETED
Sponsor

Hospices Civils de Lyon

Enrollment

26

Started

2014

Primary outcome

To determine the most effective dose of melatonin to improve sleep quality in autistic children.

Sleep Disorders

Melatonin in Relapsing-Remitting Multiple Sclerosis Patients

NCT01279876Phase 2COMPLETED
Sponsor

Tehran University of Medical Sciences

Enrollment

25

Started

2010

Primary outcome

Number of relapses

Multiple Sclerosis, Relapsing-Remitting

Study MIPAE - Melatonin and Essential Arterial Hypertension

NCT05257291Phase 2UNKNOWN
Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Enrollment

23

Started

2018

Primary outcome

Blood pressure.

Essential Hypertension

Sleep Management And Recovery After Traumatic Brain Injury in Kids: Pilot Intervention of Melatonin

NCT04932096Phase 2COMPLETED
Sponsor

Oregon Health and Science University

Enrollment

21

Started

2023

Primary outcome

Sleep Disturbances Scale for Children

Traumatic Brain InjuryCritical IllnessSleep

Melatonin for Nocturia in Parkinson's Disease

NCT02359448Phase 2UNKNOWN
Sponsor

University College, London

Enrollment

20

Started

2015

Primary outcome

Change in bother related to nocturia as measured by a standardised validated questionnaire(ICIQ-N)

Parkinson's DiseaseNocturia

Melatonin As A Novel Neuroprotectant In Preterm Infants- Dosage Study

NCT00649961Phase 2COMPLETED
Sponsor

Imperial College London

Enrollment

18

Started

2010

Primary outcome

To Find the Dose of Melatonin Required to Achieve Physiological Blood Levels in the Preterm Infants Similar to That of the Mother.

Premature BirthBrain Injury

Efficacy and Safety of Circadin for Non-24 Hour Sleep-Wake Disorder in Totally Blind Subjects

NCT00972075Phase 2COMPLETED
Sponsor

Neurim Pharmaceuticals Ltd.

Enrollment

13

Started

2006

Primary outcome

Total sleep time

Non-24 Hour Sleep-Wake DisorderBlindness

Pilot Study of Melatonin and Epilepsy

NCT00965575Phase 2COMPLETED
Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

11

Started

2011

Primary outcome

Sleep Latency Wakefulness After Sleep Onset (WASO)

Epilepsy

Randomized Controlled Trial to Assess Efficacy of Melatonin for Children During Burn Rehabilitation

NCT01598259Phase 2TERMINATED
Sponsor

Shriners Hospitals for Children

Enrollment

10

Started

2014

Primary outcome

sleep

Burns

Melatonin and Ulcerative Colitis: A Pilot Clinical Trial

NCT00790478Phase 2TERMINATED
Sponsor

Emory University

Enrollment

3

Started

2009

Primary outcome

To Estimate Treatment Effect of 12 Weeks of 5 mg/Day Supplementation With Melatonin on UC Remission, and to Use the Estimate of This Effect and Its Variability to Calculate the Sample Size Needed for a Presumably Larger and More Definitive Trial.

Ulcerative Colitis

Rivastigmine Patch Compared to Melatonin Patch in Prevention of Postoperative Delirium

NCT04189666Phase 1/2COMPLETED
Sponsor

Ain Shams University

Enrollment

180

Started

2019

Primary outcome

compare between the two groups regarding the incidence of developing Delirium among the elderly patients

Delirium

Efficacy Of Oral Melatonin To Prevent Necrotizing Enterocolitis

NCT05033639Phase 1/2COMPLETED
Sponsor

Ilocos Training and Regional Medical Center

Enrollment

100

Started

2021

Primary outcome

Number Of Preterm Infants Who Developed Necrotizing Enterocolits After Melatonin 6mg Tablet Prophylaxis

Necrotizing Enterocolitis

Evaluation of Anxiolysis and Pain Associated With Retrobulbar Eye Block for Cataract Surgery : Melatonin Versus Gabapentin

NCT01200641Phase 1/2COMPLETED
Sponsor

Qazvin University Of Medical Sciences

Enrollment

90

Started

2010

Primary outcome

pain will be assessed by verbal pain score (VPS) of 10 (0 = no pain and 10 = worst pain imaginable)

AnxietyPain

The Adjunctive Use of Melatonin Therapy in the Treatment of Obese Periodontitis Patients (Clinical and Immunological Study).

NCT04788979Phase 1/2UNKNOWN
Sponsor

University of Baghdad

Enrollment

80

Started

2021

Primary outcome

measurement of clinical periodontal parameters

Periodontal Diseases

Melatonin in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

NCT07067307Phase 1/2NOT_YET_RECRUITING
Sponsor

Mansoura University

Enrollment

80

Started

2025

Primary outcome

Response type to chemotherapy using Residual Cancer Burden (RCB) index.

Breast Cancer

The Role of Melatonin as an Adjuvant Therapy in Childhood Pneumonia

NCT06949904Phase 1/2RECRUITING
Sponsor

Mian Muhammad Hassan Ahmed

Enrollment

60

Started

2025

Primary outcome

Length of hospital stay

Pneumonia Childhood

Acute Metabolic Effects of Melatonin Treatment

NCT03204877Phase 1/2COMPLETED
Sponsor

University of Aarhus

Enrollment

36

Started

2017

Primary outcome

Insulin sensitivity

Glucose Metabolism Disorders

Safety and Efficacy of Melatonin in Patients With Multiple Progressive Primary Sclerosis

NCT03540485Phase 1/2TERMINATED
Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Enrollment

25

Started

2019

Primary outcome

Rates of neurological impairment

Sclerosis, MultipleAutoimmune Diseases of the Nervous SystemNervous System DiseasesAutoimmune Diseases

Melatonin Effects on Luteinizing Hormone

NCT00288262Phase 1/2TERMINATED
Sponsor

Scripps Health

Enrollment

20

Started

2004

Primary outcome

Hot flashes log

Hot Flashes

Pharmacokinetics of Melatonin Niosomes Oral Gel in Healthy Volunteers

NCT02845778Phase 1/2UNKNOWN
Sponsor

Khon Kaen University

Enrollment

15

Started

2016

Primary outcome

Concentration-time profile after 2.5, 5, and 10 mg Melatonin niosomes (MN) oral gel single dose administration

Pharmacokinetics of Melatonin

Immediate or Delayed Naturopathic Medicine in Combination With Neo-Adjuvant Chemotherapy for Breast Cancer

NCT02486796Phase 1/2TERMINATED
Sponsor

Midwestern Regional Medical Center

Enrollment

5

Started

2016

Primary outcome

Subject Reported Quality of Life Score

Quality of Life

Melatonin Use After Primary Total Joint Arthroplasty

NCT04795336Phase 1COMPLETED
Sponsor

NYU Langone Health

Enrollment

294

Started

2021

Primary outcome

Change in Sleep Disturbance as Measured by Epworth Sleep Score (ESS)

Osteo Arthritis Knee

Melatonin and Perinatal Outcomes in MVM-Related Fetal Growth Restriction (MIMVMFGR)

NCT07549295Phase 1ENROLLING_BY_INVITATION
Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Enrollment

240

Started

2023

Primary outcome

IUFD and neonatal death

Fetal Growth Restriction (FGR)

Multiple Dose Study Of BIIB118 (PF-05251749) In Healthy Volunteers

NCT02691702Phase 1COMPLETED
Sponsor

Biogen

Enrollment

97

Started

2016

Primary outcome

Change From Baseline for Bond and Lader Visual Analogue Scale (BL-VAS) on Days 1, 4, 7, 10, 14, 15 and 16 - Alertness

Healthy Adult SubjectsHealthy Elderly Subjects

The Effect of Melatonin on Postoperative Pain Reduction After Orthognathic Surgery

NCT03995004Phase 1SUSPENDED
Sponsor

The University of Hong Kong

Enrollment

87

Started

2022

Primary outcome

Subjective pain perception

Effect of Drugs

Comparison Between Oral Melatonin and Hydroxyzine in Pediatric Patients Undergoing Adenotonsillectomy

NCT05680584Phase 1UNKNOWN
Sponsor

Minia University

Enrollment

78

Started

2023

Primary outcome

Ease of parenteral separation.

Effect of DrugAnxiety

Oral Melatonin as Premedication During MAC for Patients Undergoing Loco-regional Chronic Subdural Hematoma Evacuation

NCT03732963Phase 1COMPLETED
Sponsor

Cairo University

Enrollment

40

Started

2018

Primary outcome

To compare propofol consumption among both groups.

Monitored Anaesthesia CareLoco-regional Chronic Subdural Hematoma Evacuation

Effectiveness of Topical Application of Melatonin On Bone Density and Implant Stability In Immediate Implantation

NCT07003243Phase 1NOT_YET_RECRUITING
Sponsor

University of Baghdad

Enrollment

25

Started

2025

Primary outcome

Change in crestal bone level around dental implants

Immediate Implant PlacementMelatonin Production

Treatment Strategies for Children With Smith-Magenis Syndrome

NCT00506259Phase 1COMPLETED
Sponsor

National Human Genome Research Institute (NHGRI)

Enrollment

23

Started

2007

Primary outcome

Change in level of melatonin (pg/ml) from baseline

Developmental Delay DisordersChromosome DeletionMental RetardationSleep Disorders, Circadian RhythmSelf Injurious Behavior

The Sun Protective Effect of Melatonin

NCT01873430Phase 1COMPLETED
Sponsor

Herlev Hospital

Enrollment

22

Started

2013

Primary outcome

Reduction of erythema assessed by digital image analysis (Image J) after treatment with melatonin/placebo before sun exposure.

Sunburn

Melatonin in Healthy Volunteers

NCT01724424Phase 1COMPLETED
Sponsor

University of Aberdeen

Enrollment

20

Started

2012

Primary outcome

Number of participants in each dose group with adverse events

Sepsis

Assessment of the Pharmacokinetics of Circadin® in Children With Neurodevelopmental Disorders and Sleep Disturbances

NCT01903681Phase 1COMPLETED
Sponsor

Neurim Pharmaceuticals Ltd.

Enrollment

16

Started

2013

Primary outcome

baseline profile of endogenous saliva melatonin concentrations and urine 6-SMT excretion

Sleep Problems

Study to Investigate the Effects of Melatonin, Temazepam & Zolpidem on Sleep EEG in Men and Women

NCT00940550Phase 1COMPLETED
Sponsor

University of Surrey

Enrollment

16

Started

2009

Primary outcome

EEG Power density in slow wave frequencies during NREM sleep

Insomnia

The Role of Melatonin in the Regulation of Blood Coagulation

NCT01741389Phase 1COMPLETED
Sponsor

University of Oslo

Enrollment

12

Started

2012

Primary outcome

Circadian variation of hemostatic factors

Spinal Cord Injured, Tetraplegia

Phase I Dose Finding Study for Melatonin in Pediatric Oncology Patients With Relapsed Solid Tumors

NCT01858155Phase 1COMPLETED
Sponsor

C17 Council

Enrollment

9

Started

2013

Primary outcome

Maximum tolerated daily dose of melatonin.

Relapsed Malignant Solid Tumor

Melatonin Postoperative Sleep Study in Breast Cancer Patients

NCT00506064Phase 1TERMINATED
Sponsor

M.D. Anderson Cancer Center

Enrollment

4

Started

2004

Primary outcome

Objective Sleep Response of Patients

Breast Cancer

Synchronization and Desynchronization Between Circadian Rhythms in Patients With Delayed Sleep Phase Syndrome (DSPS)

NCT00282061Phase 1UNKNOWN
Sponsor

Sheba Medical Center

Delayed Sleep Phase Syndrome

The Effect of Dexmedetomidine, Melatonin and Pregabalin

NCT05829148Early Phase 1UNKNOWN
Sponsor

Egymedicalpedia

Enrollment

120

Started

2023

Primary outcome

Pain Relieve

Endoscopic Sinus Surgery

Melatonin Versus Placebo in Breast Cancer

NCT01805089Early Phase 1COMPLETED
Sponsor

Dana-Farber Cancer Institute

Enrollment

95

Started

2006

Primary outcome

Absolute Plasma Estradiol Levels After 4 Month Course of Melatonin or Placebo

Breast Cancer

Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia

NCT02621944Early Phase 1RECRUITING
Sponsor

University of Florida

Enrollment

70

Started

2016

Primary outcome

To identify the maximum tolerated dose of Melatonin

Hypoxic Ischemic Encephalopathy

Melatonin's Effects on Treatment Of Diabetes Mellitus

NCT02691897Early Phase 1UNKNOWN
Sponsor

Shiraz University of Medical Sciences

Enrollment

60

Started

2019

Primary outcome

Fasting blood sugar (FBS)

Diabetes Mellitus

Effect of Melatonin on Postoperative Pain After Simple Nephrectomy

NCT06872944Early Phase 1COMPLETED
Sponsor

Cairo University

Enrollment

40

Started

2025

Primary outcome

Pain score (VAS) at 24 h postoperatively

Pain Score (VAS) at 24 h Postoperatively

Melatonin and Osteogenic Loading on Osteopenia

NCT04233112Early Phase 1ACTIVE_NOT_RECRUITING
Sponsor

Duquesne University

Enrollment

40

Started

2020

Primary outcome

Bone mineral density

Osteopenia

Melatonin in Patients With Multiple Sclerosis (MS).

NCT03498131Early Phase 1COMPLETED
Sponsor

Providence Health & Services

Enrollment

30

Started

2018

Primary outcome

Urine Melatonin Levels

Relapsing Remitting Multiple Sclerosis

The Effect of Melatonin on Early Signs of Hypertension in Teenagers With Diabetes Mellitus Type 1

NCT02644590Early Phase 1UNKNOWN
Sponsor

Sheba Medical Center

Enrollment

30

Started

2016

Primary outcome

blood pressure monitoring , pre and post treatment with melatonin

Diabetes Mellitus, Type 1Hypertension

The Role of Preoperative Melatonin in Reducing the Inhaled Isoflurane Requirements in Open Nephrectomy

NCT04959825Early Phase 1COMPLETED
Sponsor

Cairo University

Enrollment

30

Started

2021

Primary outcome

Inhaled isoflurane requirement (volume%) to maintain entropy readings 40-60

Postoperative Pain

Effects of Selenium and Melatonin on Ocular Ischemic Syndrome

NCT04005222Early Phase 1COMPLETED
Sponsor

Beytepe Murat Erdi Eker State Hospital

Enrollment

28

Started

2014

Primary outcome

To determine the effects of selenium on anterior chamber (AC ) malondialdehyde (MDA) and AC glutathione (GSH) levels in patients with Ocular ischemic syndrome

Anterior Segment Ischemia (Diagnosis)

Melatonin Replacement Therapy in Pinealectomized Patients

NCT03885258Early Phase 1COMPLETED
Sponsor

University of Sao Paulo

Enrollment

5

Started

2017

Primary outcome

cardiac autonomic function - heart rate variability

Pineal Tumor

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