40 registrations that name melatonin as a study arm and are recruiting or about to, as ClinicalTrials.gov listed them on Oct 20, 2026. Read each listing for its full criteria and current status.
Kymata never assesses eligibility. Each listing names its own criteria; only its study team can say whether someone can join. Trial doses are given under the trial's monitoring and are not a schedule for anyone outside it.
Filter 40 registrations
Status
Phase
18US sites across 13 states
1
2 to 4
5 to 19
20 or more
All 40 registrations
RecruitingNCT05084196
Melatonin for Prevention of Kidney Injury
Phase 3
Rutgers, The State University of New Jersey
About 300 people
Started Jun 5, 2023
In plain words A Phase 3 study of melatonin in people 18 to 75, run by Rutgers, The State University of New Jersey. It plans to enroll about 300 people at 2 US sites.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 75. Conditions: Acute Kidney Injury; Adverse Drug Event.
Aged 18 to 75 years
Currently prescribed vancomycin with the presumption that therapy will be continued for at least 3 days based on a review of subject status.
The exclusion criteria are on the listing.
What it tests, as registered
Melatonin; Placebo Capsule
Registered summary
This study will evaluate the safety and effectiveness of melatonin for the prevention of antibiotic associated acute kidney injury in hospitalized patients.
Where, as registered
2 US sites in 1 state.
RecruitingNCT04588233
Melatonin Adolescent Research Study
No phase
Loma Linda University
About 80 people
Started Sep 15, 2021
In plain words A study of melatonin in people 13 to 17, run by Loma Linda University. It plans to enroll about 80 people at 2 US sites.
Who it lists and where
Who the trial lists, as registered
Lists people 13 to 17. Conditions: Sleep Disorders in Children.
Self-identified sleep difficulties (e.g., difficulty falling asleep, staying asleep, or premature waking resulting in short or disrupted sleep).
Ages 13 to 17 years old
Able to understand, read, and write in English
Melatonin naive
The exclusion criteria are on the listing.
What it tests, as registered
Melatonin; Placebo
Registered summary
The present study will use a within-person, randomized cross-over experimental design to test the effects of exogenous melatonin supplementation on the sleep and daytime functioning of typically developing adolescents with short or disrupted sleep of behavioral origins (i.e., difficulty falling asleep, staying asleep, or premature waking resulting in short or disrupted sleep not attributed to an organic sleep condition).
Where, as registered
2 US sites in 1 state.
RecruitingNCT02621944
Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia
Early phase 1
University of Florida
About 70 people
Started Nov 9, 2016
In plain words An early phase 1 study of melatonin in people up to 6 hours, run by University of Florida. It plans to enroll about 70 people at 2 US sites.
Who it lists and where
Who the trial lists, as registered
Lists people up to 6 hours. Conditions: Hypoxic Ischemic Encephalopathy.
Eligible infants are >36 0/7th weeks gestation,
pH (cord or neonatal) <7.0,
base deficit >16 mEq/L,
no available blood gas,
6 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Melatonin; Magnetic Resonance Imaging; Pharmacokinetics; Neurological Outcome Assessment
Registered summary
Hypoxic-Ischemic Encephalopathy (HIE) occurs in 20 per 1000 births. Only 47% of neonates treated with the state of the art therapy (induced systemic hypothermia) have normal outcomes. Therefore, other promising therapies that potentially work in synergy with hypothermia to improve neurologic outcomes need to be tested. One potential agent is melatonin. Melatonin is a naturally occurring substance produced mainly from the pineal gland. Melatonin is widely known for its role in regulating the circadian rhythm, but it has many other effects that may benefit infants with HI injury. The full summary is on the listing.
Where, as registered
2 US sites in 1 state.
RecruitingNCT07542756
A SMART Approach to Evaluating the Benefits of Common Prescription and OTC Medications for Insomnia
Phase 4
University of Pennsylvania
About 1,200 people
Started May 1, 2026
In plain words A Phase 4 study of melatonin in people 18 to 80, run by University of Pennsylvania. It plans to enroll about 1,200 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 80. Conditions: Insomnia; Insomnia Disorder; Chronic Insomnia; Chronic Insomnia Disorder.
Adults aged 18-80 years.
Meet DSM-5 criteria for Insomnia Disorder.
Score ≥15 on the Insomnia Severity Index (ISI).
Sleep initiation and/or maintenance complaints: ≥30 minutes in duration, occurring ≥3 nights/week, with a duration of ≥3 months.
3 more inclusion criteria and the exclusion criteria are on the listing.
The purpose of this study is to assess the relative effectiveness, safety, and durability of the most commonly used prescription (zolpidem, trazodone) and over-the-counter (OTC) (melatonin, diphenhydramine) medications for insomnia, as well as a less commonly used prescription that may have a better risk/benefit profile (doxepin).
Where, as registered
1 US site in 1 state.
RecruitingNCT03954899
Disease Modifying Potential of 5mg of Melatonin on Cognition and Brain Health in Aging
No phase
Natalie Denburg
About 230 people
Started Nov 12, 2019
In plain words A study of melatonin in people 56 to 85, run by Natalie Denburg. It plans to enroll about 230 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists people 56 to 85; healthy volunteers accepted. Conditions: Mild Cognitive Impairment; Cognitive Decline; Healthy Aging.
between ages of 56-85 years
all participants must score 18 or above on Montreal Cognitive Assessment (MoCA);
all participants must have a clinical dementia rating (CDR) Sum of boxes <1;
need to be willing to undergo CSF LP on two occasions over the course of their participation,
6 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
melatonin; placebo
Registered summary
The study will examine whether 5mg melatonin (over the counter, OTC) over a 9-month period improves Alzheimer's disease (AD) biomarkers and cognitive function in two groups of individuals: those with mild cognitive impairment (MCI+) and those who are not (MCI-). AD biomarkers will be measured from cerebrospinal fluid (CSF) obtained from lumbar punctures. Cognitive function will be evaluated with routine neuropsychological tests. AS OF AUGUST 2024, THE LUMBAR PUNCTURE PROCEDURES FOR THIS CLINICAL TRIAL HAVE BEEN ELIMINATED. THAT IS, PARTICIPANTS ARE NO LONGER RECEIVING A LUMBER PUNCTURE. The full summary is on the listing.
Where, as registered
1 US site in 1 state.
RecruitingNCT06104280
Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment
Observational
University of Alabama at Birmingham
About 200 people
Started Jan 6, 2025
In plain words An observational study of melatonin in people 18 to 80, run by University of Alabama at Birmingham. It plans to enroll about 200 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 80; healthy volunteers accepted. Conditions: Opioid Use Disorder; Sleep Disturbance.
Adults (18+)
prescribed one of three medications for opioid use disorder (methadone, XR-NTX, buprenorphine) or healthy control
stable on MOUD (no dose change) for the past month
positive on urine drug screen (UDS) for buprenorphine or methadone if prescribed those medications
Opioid use disorder (OUD) is a treatable medical illness with three medications FDA approved for treatment. However, persons with OUD report significant sleep disturbance, even when treated with medications for opioid use disorder, leading to high rates of relapse. In this project, we will investigate a special set of photosensitive neurons in the retina as an underlying mechanism for circadian rhythm and sleep disturbance from opioid use and medications for OUD that could lead to novel intervention and improve treatment outcomes.
Where, as registered
1 US site in 1 state.
RecruitingNCT05358834
Testing Effects of Melatonin on Uterine Contractions in Women
No phase
Brigham and Women's Hospital
About 120 people
Started Jan 1, 2023
In plain words A study of melatonin in female participants 18 to 35, run by Brigham and Women's Hospital. It plans to enroll about 120 people at 1 US site.
≥38 weeks of pregnancy with a single fetus at time of study.
The exclusion criteria are on the listing.
What it tests, as registered
Melatonin; Placebo
Registered summary
The study will extend recent discoveries that have been made in basic human physiology related to responses melatonin and uterine contractions in late- or full-term pregnant women. The basic physiology work has been conducted in in vitro models of the human myometrium characterizing its responses to melatonin, and in pilot in vivo studies correlating the number of uterine contractions with melatonin concentrations that were manipulated by different types of light exposure. The full summary is on the listing.
Where, as registered
1 US site in 1 state.
RecruitingNCT06826755
Melatonin Effects on Cardiovascular Disease Mechanisms in Midlife Women: A Randomized Clinical Trial
No phase
Mayo Clinic
About 70 people
Started May 23, 2025
In plain words A study of melatonin in female participants 40 to 55, run by Mayo Clinic. It plans to enroll about 70 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists female participants 40 to 55. Conditions: Perimenopause; Hypertension.
Age 40-55 years old
Female individuals with intact uterus and at least one ovary
Hypertension o Defined as a prior diagnosis of hypertension, use of antihypertensive agents, or office SBP/DBP ≥130/80 mmHg
On stable medical regimen (≥ 2 months) if taking other medications
The exclusion criteria are on the listing.
What it tests, as registered
Terry Naturally® melatonin 5mg SR; Placebo
Registered summary
The purpose of this research is to study the effects of 12 weeks of melatonin supplementation compared to placebo in women who are in the menopause transition (perimenopause) and have high blood pressure.
Where, as registered
1 US site in 1 state.
RecruitingNCT05701969
Effect of Melatonin on Sleep Patterns of Resident Trainees During Night Float Shift
Early phase 1
University of Virginia
About 50 people
Started May 30, 2022
In plain words An early phase 1 study of melatonin in people 18 and older, run by University of Virginia. It plans to enroll about 50 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists people 18 and older; healthy volunteers accepted. Conditions: Sleep Disorders, Circadian Rhythm.
Post-Graduate Year 1-5
Current enrollment in anesthesiology, general surgery, obstetrics and gynecology, general medicine, or pediatrics residency at the Unversity of Virginia
The exclusion criteria are on the listing.
What it tests, as registered
Melatonin; Placebo
Registered summary
Anesthesiology residency requires extended and overnight shifts, which may negatively impact the quantity and quality of sleep. Previous studies have investigated the effect of night float shift work on anesthesiology resident sleep and performance and demonstrated that total sleep quantity and time spent in deep and rapid eye movement (REM) sleep were significantly reduced during night float and did not return to baseline after 3 nights of recovery. Melatonin is a hormone produced by the pineal gland, which regulates the circadian rhythm that governs sleep. The full summary is on the listing.
Where, as registered
1 US site in 1 state.
RecruitingNCT06226025
Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder
Phase 2
Leslie Swanson
About 50 people
Started Aug 13, 2024
In plain words A Phase 2 study of melatonin in people 18 to 60, run by Leslie Swanson. It plans to enroll about 50 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 60. Conditions: Bipolar Disorder; Delayed Sleep-Wake Phase Disorder.
Capable of giving informed consent
Meet The Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria for bipolar disorder (BD) I or II
Evening chronotype per the Morningness-Eveningness Questionnaire (MEQ) defined by a score of <42
At least mild depressive symptoms on the Patient Health Questionnaire (PHQ)-9 defined by a score ≥5
4 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Melatonin; Placebo; Behavioral sleep intervention; Behavioral sleep control
Registered summary
The purpose of this study is to test whether a dietary supplement (low-dose melatonin) commonly used to treat night owls, administered in conjunction with a behavioral sleep intervention, will help to shift the brain clock earlier and improve mood and sleep in bipolar disorder. Eligible participants will be randomized to receive melatonin plus a behavioral sleep intervention or placebo plus a behavioral sleep placebo. The full summary is on the listing.
Where, as registered
1 US site in 1 state.
RecruitingNCT07651514
The Effect of a Daily Magnesium and Melatonin Supplement on Sleep Quality in People With Nighttime Leg Cramps
No phase
StudySetGo
About 50 people
Starts Oct 10, 2026 (estimated)
In plain words A study of melatonin in people 40 to 75, run by StudySetGo. It plans to enroll about 50 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists people 40 to 75; healthy volunteers accepted. Conditions: Poor Sleep Quality; Leg Cramps, Nocturnal.
Adults aged 40-75 years
Self-reported poor sleep quality (PSQI >5) at screening
Self-reported nocturnal leg cramp averaging ≥4 episodes per fortnight at screening
Capacity to understand and provide electronic informed consent
3 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Magnesium and melatonin based multi-ingredient dietary supplementation; Placebo
Registered summary
Participants are being invited to take part in a research study. Before deciding whether to take part, it is important for participants to understand why the research is being done and what it will involve. Purpose: This study will investigate whether a multi-ingredient nutritional supplement containing magnesium and melatonin can improve sleep quality in adults who experience disrupted sleep due to nighttime leg cramps. What participation involves: Participation lasts 8 weeks. The full summary is on the listing.
Where, as registered
1 US site in 1 state.
RecruitingNCT06093477
Studying Melatonin and Recovery in Teens
No phase
Stanford University
About 45 people
Started May 30, 2024
In plain words A study of melatonin in people 12 to 18, run by Stanford University. It plans to enroll about 45 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists people 12 to 18. Conditions: Juvenile; Scoliosis; Scoliosis Idiopathic; Scoliosis; Adolescence; Scoliosis;Congenital; Kyphosis; Spondylolisthesis; Pectus Surgery; Hip Surgery.
Age 12-18 years
Participants undergoing elective major musculoskeletal surgery for eligible conditions
California state resident
Regular access to internet and smartphone
3 more inclusion criteria and the exclusion criteria are on the listing.
The goal of this feasibility clinical trial is to learn if melatonin can help teens having major musculoskeletal surgery by promoting healthy sleep. Melatonin is available as a dietary supplement that may be effective in promoting longer, higher quality sleep. This study will assess the feasibility and acceptability of melatonin for teens undergoing major musculoskeletal surgery, as well as determine optimal measured outcomes (sleep, pain, health-related quality of life) at short- and long-term follow-up.
Where, as registered
1 US site in 1 state.
RecruitingNCT04547439
Sleep, Diabetic Retinopathy and Melatonin
Phase 2
University of Illinois at Chicago
About 42 people
Started Feb 3, 2021
In plain words A Phase 2 study of melatonin in people 40 to 65, run by University of Illinois at Chicago. It plans to enroll about 42 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists people 40 to 65. Conditions: Diabetes Mellitus; Diabetic Retinopathy.
Type 2 diabetes (clinically diagnosed, taking anti-diabetes medications or history of elevated A1C≥6.5%)
40-65 years of age
Diabetic retinopathy of at least moderate degree
The exclusion criteria are on the listing.
What it tests, as registered
Melatonin; Placebo
Registered summary
This study explores the use of melatonin in patients with diabetic retinopathy
Where, as registered
1 US site in 1 state.
RecruitingNCT07336277
Sleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Patients
Phase 3
Emory University
About 30 people
Started Jun 2, 2026
In plain words A Phase 3 study of melatonin in people 18 to 65, run by Emory University. It plans to enroll about 30 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 65. Conditions: Orthopedic Trauma; Sleep Quality.
Hospitalized with an isolated lower extremity orthopedic injury requiring surgical intervention.
Expected hospital stay of at least 3 days.
No known pre-existing sleep disorders.
No current use of sleep aids, such as zolpidem or melatonin, before hospitalization
The goal of this study is to determine whether a multimodal sleep pathway can enhance sleep quality in hospitalized patients with orthopedic trauma. It will also evaluate the effect of this pathway on opioid use and pain perception during recovery. The full summary is on the listing.
Where, as registered
1 US site in 1 state.
RecruitingNCT07046429
Affect of Melatonin on Sleep and Cognition in Cirrhosis
No phase
Weill Medical College of Cornell University
About 18 people
Started Aug 5, 2025
In plain words A study of melatonin in people 18 and older, run by Weill Medical College of Cornell University. It plans to enroll about 18 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists people 18 and older. Conditions: Hepatic Encephalopathy; Covert Hepatic Encephalopathy; Cirrhosis; Sleep Disturbances and Insomnia.
Cirrhosis with clinically significant portal hypertension or decompensation defined by Baveno VII criteria \[de Franchis R et al 2022\]
Adults over age 18
CHE (defined by PHES≤ -4) or previously diagnosed HE
Disturbed sleep, with Pittsburgh Sleep Quality Index (PSQI) ≥5
1 more inclusion criterion and the exclusion criteria are on the listing.
What it tests, as registered
Melatonin tablet 3 mg once daily; Thiamine
Registered summary
The goal of this clinical trial is to learn the affect of melatonin on sleep, cognitive function, and quality of life (QoL) in patients with cirrhosis and a complication called hepatic encephalopathy (HE). The main questions this study aims to answer are: * Does taking melatonin increase REM sleep, an important part of healthy sleep that is reduced in cirrhosis? * Does taking melatonin improve cognitive function and reported QoL? This is a pilot study, where participants will: * take one month of melatonin, followed by one month of thiamine, which is another supplement but is not suspected to… The full summary is on the listing.
Where, as registered
1 US site in 1 state.
RecruitingNCT05541276
MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children
Phase 3
Arash Afshari
About 676 people
Started Jan 21, 2025
In plain words A Phase 3 study of melatonin in people 1 to 6, run by Arash Afshari. It plans to enroll about 676 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 1 to 6. Conditions: Emergence Delirium.
Patients aged 1-6 years
Elective surgical procedure of en axpected duration of at least 30 minutes in general anesthesia
The exclusion criteria are on the listing.
What it tests, as registered
Melatonin; Isotonic sodium chloride solution
Registered summary
Postoperative agitation and emergence delirium describe a spectrum of symptoms of early postoperative negative behavior, in which the child experiences a variety of behavioral disturbances including crying, thrashing, and disorientation during early awakening from anaesthesia. The symptoms are common with a reported incidence of approximately 25%. Some clinical trials have studied the effect of prophylactic oral melatonin for reducing the risk of emergence agitation in children, some finding a considerable dose-response effect. Melatonin has a low bio-availability of approximately 15 %. The full summary is on the listing.
Where, as registered
No US site; Denmark (1).
RecruitingNCT05651347
Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth Restriction
Phase 3
Monash University
About 336 people
Started May 29, 2019
In plain words A Phase 3 study of melatonin in female participants 18 and older, run by Monash University. It plans to enroll about 336 people at 12 sites, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists female participants 18 and older; healthy volunteers accepted. Conditions: Fetal Growth Retardation; Stillbirth and Fetal Death; Pregnancy Preterm.
Singleton Pregnancy
Severe fetal growth restriction, defined as:
Abdominal circumference ≤3rd centile for gestational age according to charts supplied that have been adapted from Westerway et al; or
Abdominal circumference <10th centile in combination with at least one abnormal fetoplacental Doppler study, being:
5 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Placebo; Melatonin 10 MG
Registered summary
Fetal growth restriction (FGR) is a significant health care issue, affecting 20,000 Australian pregnancies every year. Undetected FGR is one of the key risk factors for stillbirth, but FGR can also cause significant impairments in short and long-term health outcomes for the child. It is a major risk factor for preterm birth and is a recognised causal pathway to the neurodevelopmental injury underlying cognitive and behavioural impairment and cerebral palsy. The full summary is on the listing.
Where, as registered
No US site; Australia (9), New Zealand (3).
RecruitingNCT06062953
Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia
Phase 2 and 3
Lone Baandrup
About 255 people
Started Sep 18, 2023
In plain words A Phase 2 and 3 study of melatonin in people 16 to 64, run by Lone Baandrup. It plans to enroll about 255 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 16 to 64. Conditions: Psychiatric Disorders; Insomnia.
16 to 64 years of age
ICD-10 diagnosis of a current or previous mental or behavioral disorder (F20-F69, F84, F90-95)
For the diagnoses F84 and F90 a previous period of treatment with melatonin is required
For the 16-17 years old: Non-pharmacological treatment options including sleep hygiene education, weighted blanket or other gravity products have been tested with insufficient effect
4 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Melatonin; Quetiapine; Placebo
Registered summary
The goal of this investigator-initiated, randomized, blinded, 3-armed placebo-controlled, pragmatic, clinical superiority trial is to examine the efficacy of melatonin or low-dose quetiapine versus placebo for treatment of insomnia in patients with psychiatric disorders. The aims of the study are: * To examine the efficacy of melatonin or low-dose quetiapine versus placebo for treatment of insomnia * To examine how melatonin or low-dose quetiapine affects global symptom severity, sleep quality, psychosocial functioning and subjective well-being. The full summary is on the listing.
Where, as registered
No US site; Denmark (1).
RecruitingNCT07472075
Melatonin Versus Placebo for Bipolar Disorder
Phase 2
Lars Vedel Kessing
About 200 people
Started May 8, 2026
In plain words A Phase 2 study of melatonin in people 18 to 70, run by Lars Vedel Kessing. It plans to enroll about 200 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 70. Conditions: Bipolar Affective Disorder.
Bipolar disorder with diagnosis confirmed by SCAN interview
Age 18 - 70 years
The participants must be able to read and understand the participant information in their native language and consent (English and Danish)
Habile (i.e able to give informed consent)
The exclusion criteria are on the listing.
What it tests, as registered
Melatonin; Placebo
Registered summary
The objective with this study is to conduct a 6-month RCT comparing effects of add-on melatonin versus add-on placebo on mood stabilisation and other critical patient outcomes in patients with BD and to test whether principal effects are antimanic, antidepressant and/or prophylactic against relapse
Where, as registered
No US site; Denmark (1).
RecruitingNCT03438526
The Basel BOMP-AID Randomized Trial
Phase 4
University Hospital, Basel, Switzerland
About 190 people
Started Jan 3, 2022
In plain words A Phase 4 study of melatonin in people 55 and older, run by University Hospital, Basel, Switzerland. It plans to enroll about 190 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 55 and older. Conditions: Hypoactive Delirium.
Adult patients (aged 55 years or older)
Current delirium (hypoactive type) detected by a specialised assessment method: ICDSC score >2 and RASS score < 0
The exclusion criteria are on the listing.
What it tests, as registered
Melatonin (Circadin ®); Placebo
Registered summary
Delirium is a neurobehavioural syndrome that frequently develops in the postoperative and/or ICU setting. The incidence of elderly patients who develop delirium during hospital stay ranges from 11-82%. Delirium was first described more than half a century ago in the cardiac surgery population, where it was already discovered as a state that might be accompanied by serious complications such as prolonged ICU and hospital stay, reduced quality of life and increased mortality. The full summary is on the listing.
Where, as registered
No US site; Switzerland (1).
RecruitingNCT07617922
Melatonin and Solifenacin for Double-J Ureteral Stent Symptoms
Phase 2
Beni-Suef University
About 189 people
Started May 7, 2026
In plain words A Phase 2 study of melatonin in people 18 to 60, run by Beni-Suef University. It plans to enroll about 189 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 60. Conditions: Ureteral Stent-Related Symptoms; Ureteral Calculi; Lower Urinary Tract Symptoms.
Age 18 to 60 years.
Patients undergoing unilateral ureteroscopy or ureteroscopic lithotripsy with insertion of a unilateral Double-J ureteral stent.
Ability to understand and complete the study questionnaires.
Willingness to participate and provide written informed consent.
The exclusion criteria are on the listing.
What it tests, as registered
Solifenacin; Melatonin
Registered summary
Double-J ureteral stents are commonly inserted after ureteroscopy, but they may cause bothersome urinary symptoms, pain, sleep disturbance, and reduced quality of life. This prospective randomized assessor-blinded three-arm clinical trial will compare oral solifenacin, oral melatonin, and their combination for improving ureteral stent-related symptoms in adult patients after unilateral ureteroscopic lithotripsy with insertion of a unilateral Double-J ureteral stent. The full summary is on the listing.
Where, as registered
No US site; Egypt (1).
RecruitingNCT07695246
Efficacy of CBT-I With Adjuvant Melatonin in Older Adults Chronic Insomnia
No phase
The University of Hong Kong
About 183 people
Started Aug 1, 2026
In plain words A study of melatonin in people 60 and older, run by The University of Hong Kong. It plans to enroll about 183 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 60 and older. Conditions: Insomnia; Aging; Sleep Disorders.
Chinese aged ≥ 60.
Provision of written informed consent.
Having a DSM-5 diagnosis of insomnia disorder (i.e., having difficulty initiating sleep, maintaining sleep, or early morning awakening at least three times a week for at least three months, with clinically significant impairment or…
Having a score of > 14 on the ISI, indicating clinical insomnia.
This study tests the efficacy of cognitive behavioural therapy for insomnia (CBT-I) with or without adjunct melatonin in older adults with insomnia. Adults aged 60 or above with chronic insomnia will be randomly assigned to one of three groups: (1) CBT-I plus nightly melatonin, (2) CBT-I plus nightly placebo tablet, or (3) sleep health psychoeducation plus nightly placebo tablet. All group sessions occur weekly for four weeks.
Where, as registered
No US site; Hong Kong (1).
RecruitingNCT06768580
Effect of Oral Melatonin Versus Intraoperative Lidocaine Infusion on Incidence of Postoperative Delirium in Elderly Patients Undergoing Total Hip Arthroplasty
No phase
Tanta University
About 135 people
Started Jan 15, 2025
In plain words A study of melatonin in people 65 and older, run by Tanta University. It plans to enroll about 135 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 65 and older. Conditions: Oral Melatonin; Lidocaine Infusion; Postoperative Delirium; Elderly Patients; Total Hip Arthroplasty.
Elderly patients aged >65 years old undergoing unilateral total hip arthroplasty.
Patients with body mass index (BMI) (18-30) kg/m2.
American Society of Anesthesiologists (ASA) physical status I-III, scheduled to undergo unilateral total hip arthroplasty.
The exclusion criteria are on the listing.
What it tests, as registered
Melatonin; Lidocaine; Placebo
Registered summary
The aim of this study is to assess the effect of oral melatonin versus intraoperative lidocaine infusion on incidence of postoperative delirium in elderly patients undergoing total hip arthroplasty under spinal anesthesia.
Where, as registered
No US site; Egypt (1).
RecruitingNCT06489327
Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery
No phase
Al-Azhar University
About 120 people
Starts Jul 12, 2026 (estimated)
In plain words A study of melatonin in people 4 to 10, run by Al-Azhar University. It plans to enroll about 120 people at 2 sites, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 4 to 10. Conditions: Preoperative Anxiety.
Patients of either sex
age from 4 to 14 years
Patients with American society Anesthesiologist physical status I and II
Preoperative anxiety is a common issue in pediatric anesthesia. Children often experience anxiety and uneasiness due to uncertain outcomes. Surgery and anesthesia are among the most traumatic experiences for children, often considered anxiety-inducing medical treatments. Because they lack control over their environment and circumstances, children undergoing medical procedures typically experience significant unease or anxiety. Several studies have reported that 50%-80% of children experience preoperative anxiety. In order to reduce kids anxiety intensity, several measures are utilized. The full summary is on the listing.
Where, as registered
No US site; Egypt (1), Iraq (1).
RecruitingNCT07375342
Melatonin for Post Tonsillectomy Emergence Agitation in Pediatric
No phase
Benha University
About 120 people
Started Dec 10, 2025
In plain words A study of melatonin in people 4 to 10, run by Benha University. It plans to enroll about 120 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 4 to 10. Conditions: Post Tonsillectomy Emergence Agitation.
American Society of Anesthesiologists (ASA) physical status I or II.
Parent/legal guardian provides written informed consent
The exclusion criteria are on the listing.
What it tests, as registered
Melatonin; Placebo
Registered summary
The goal of this clinical trial is to learn if melatonin can decrease emergence agitation in pediatric post tonsillectomy. The main questions it aims to answer are: Does melatonin decrease emergence agitation in pediatric post tonsillectomy? What medical problems do participants have when taking melatonin? Researchers will compare melatonin to a placebo (a look-alike substance that contains no drug) to see if melatonin works todecrease emergence agitation in pediatric post tonsillectomy Participants will receive Oral melatonin at a dose of 0.5 mg/kg (maximum 20 mg) administered 30 minutes… The full summary is on the listing.
Where, as registered
No US site; Egypt (1).
RecruitingNCT07344467
Oral Melatonin Versus Oral Pregabalin on Postoperative Pain and Anxiety Following Spine Surgery
No phase
Tanta University
About 105 people
Started Jan 17, 2026
In plain words A study of melatonin in people 21 to 60, run by Tanta University. It plans to enroll about 105 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 21 to 60. Conditions: Oral; Melatonin; Pregabalin; Postoperative Pain; Anxiety; Spine Surgery.
Patients aged 21-60 years old.
Both sexes.
Patients of American Society of Anesthesiologists (ASA) physical status I \& II.
This study aims to compare the efficacy of using Melatonin versus Pregabalin on postoperative pain and anxiety after spine surgeries.
Where, as registered
No US site; Egypt (1).
RecruitingNCT05502900
Adjuvant Melatonin for Uveal Melanoma
Phase 3
Gustav Stalhammar
About 100 people
Started Oct 2, 2022
In plain words A Phase 3 study of melatonin in people 18 and older, run by Gustav Stalhammar. It plans to enroll about 100 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 and older. Conditions: Uveal Melanoma; Uveal Melanoma, Posterior, Medium/Large Size; Eye Cancer, Intraocular Melanoma.
The patient is ≥18 years
The patient has given his/her written informed consent to participate in the trial.
The patient has a melanoma originating in the choroid or in the ciliary body, as diagnosed by clinical methods and/or histological examination.
The patient's tumor is of size category T3d or higher, or stage IIIB or IIIC according to the American Joint Committee on Cancer (AJCC, version 8) criteria.
7 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Melatonin
Registered summary
Uveal melanoma (UM) is the most common type of cancer inside the eyes of adults. Almost half of all patients diagnosed with UM will eventually develop metastases. Once metastases occur, the median patient survival is short. In this trial, we will test if treatment with Melatonin after primary tumor diagnosis can prevent or delay the development of metastases. 100 patients diagnosed with primary UM will be randomized to either treatment with Melatonin tablets (20 mg at night), or to a control group. Both groups will be followed for 5 years. The full summary is on the listing.
Where, as registered
No US site; Sweden (1).
RecruitingNCT06236932
Susceptibility to Infectious Diseases in obEsity: an endocRine trAnslational socioLogic Evaluation, "SIDERALE"
No phase
Federico II University
About 100 people
Started Dec 29, 2023
In plain words A study of melatonin in people 18 to 65, run by Federico II University. It plans to enroll about 100 people at 4 sites, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 65. Conditions: Obesity; Type2diabetes; Lipodystrophy; Infections; Obesity Associated Disorder.
essential obesity (BMI : 30-35 Kg/m2)
genetic forms of obesity (BMI: 30-35 Kg/m2)
obesity (BMI:30-35 Kg/m2) associated with T2DM
obesity (BMI:30-35 Kg/m2) associated with endocrinopathies
1 more inclusion criterion and the exclusion criteria are on the listing.
What it tests, as registered
Mediterranean diet; Melatonin supplementation
Registered summary
Obesity is a life-threatening disease, defined by excessive fat accumulation that increases the risk of other diseases such as cardiovascular events, hypertension, diabetes and cancer. Obesity is also a risk factor for nosocomial infections and is associated with worse COVID-19 outcomes, although anthropometric measurements are not routinely recorded during hospitalization and lack of a registry data does not allow performing retrospective studies.Obesity is closely related to chronodisruption, characterized by deregulation of physiological and behavioral central and peripheral circadian… The full summary is on the listing.
Where, as registered
No US site; Italy (4).
RecruitingNCT07737665
Efficacy of Melatonin Treatment on Sleep Quality Improvement in Inflammatory Bowel Disease Patients With Clinical Remission
Phase 4
Mahidol University
About 90 people
Started Apr 1, 2025
In plain words A Phase 4 study of melatonin in people 18 and older, run by Mahidol University. It plans to enroll about 90 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 and older. Conditions: IBD (Inflammatory Bowel Disease).
IBD patients with clinical remission Crohn's disease: HBI < 5 Ulcerative colitis: Partial Mayo score 0-1 w/o bloody stool
Age > 18 years
PSQI score > 5
No medical adjustment for 2 months and use corticosteroids not more than Prednisolone equivalent 5 mg/day
The exclusion criteria are on the listing.
What it tests, as registered
Melatonin ("Circadin"); Placebo
Registered summary
Sleep disturbances are common in patients with inflammatory bowel disease (IBD) and are associated with increased disease activity and reduced quality of life. Melatonin, a hormone regulating circadian rhythms, has shown potential anti-inflammatory and sleep-promoting effects in preliminary studies. This study aimed to evaluate the efficacy of melatonin supplementation on sleep quality in IBD patients in clinical remission.
Where, as registered
No US site; Thailand (1).
RecruitingNCT07553143
Effect of Preoperative Melatonin on Quality of Recovery After Elective Laparoscopic Cholecystectomy
No phase
Armed Forces Medical Institute Bangladesh
About 84 people
Started May 1, 2026
In plain words A study of melatonin in people 18 to 60, run by Armed Forces Medical Institute Bangladesh. It plans to enroll about 84 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 60. Conditions: Laparoscopic Cholecystectomy; Postoperative Quality of Recovery; Preoperative Anxiety; Postoperative Sleep Quality; Opioid Consumption, Postoperative; PONV in Laparoscopic Cholocystectomies.
Age 18-60 years
American Society of Anesthesiologists (ASA) physical status I-II
Scheduled for elective laparoscopic cholecystectomy under general anesthesia
Able to understand and provide informed consent
2 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Melatonin (N-acetyl-5-methoxytryptamine); Placebo
Registered summary
Laparoscopic cholecystectomy is one of the most commonly performed abdominal surgical procedures worldwide. Although the widespread implementation of Enhanced Recovery after Surgery (ERAS) protocols has improved perioperative outcomes, many patients continue to experience postoperative pain, sleep disturbance, anxiety, nausea, and fatigue, symptoms that collectively impair overall quality of recovery (QoR). The full summary is on the listing.
Where, as registered
No US site; Bangladesh (1).
RecruitingNCT05247125
The Role of Circadian Factors in Regulation of Neuroplasticity in Ischemic Stroke (Interventional)
Phase 4
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
About 80 people
Started Mar 1, 2022
In plain words A Phase 4 study of melatonin in people 18 to 80, run by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health. It plans to enroll about 80 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 80. Conditions: Ischemic Stroke, Acute; Sleep Disorders, Circadian Rhythm.
acute (symptom onset to admission <1 days) ischemic stroke
ischemic stroke affecting the branches of anterior cerebral artery, middle cerebral artery and posterior cerebral artery
age 18-80 years
moderate or severe stroke (National Institutes of Health Stroke Scale, NIHSS>=5)
2 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Blue light exposure + Melatonin treatment; Melatonin treatment; Blue light exposure; Placebo
Registered summary
There is a lack of complex studies which could establish the association between genetic circadian factors with the features and short-term outcomes of ischemic stroke, as well as the effects of various auxiliary therapies for circadian rhythm modulation for neuroplasticity enhancement and improvement of short-term outcomes in ischemic stroke. The main research hypothesis is that circadian factors influence the recovery from ischemic stroke via sleep-mediated regulation of synaptic plasticity. The full summary is on the listing.
Where, as registered
No US site; Russia (1).
RecruitingNCT06949904
The Role of Melatonin as an Adjuvant Therapy in Childhood Pneumonia
Phase 1 and 2
Mian Muhammad Hassan Ahmed
About 60 people
Starts May 2025 (estimated)
In plain words A Phase 1 and 2 study of melatonin in people 1 month to 12, run by Mian Muhammad Hassan Ahmed. It plans to enroll about 60 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 1 month to 12. Conditions: Pneumonia Childhood.
1 month to 12 years
Both genders
Patient diagnosed as having pneumonia or severe pneumonia according to WHO definition
The exclusion criteria are on the listing.
What it tests, as registered
Melatonin
Registered summary
The goal of this study is to compare the mean length of hospital stay between children with pneumonia receiving melatonin as an adjuvant therapy and those receiving standard of care alone. The hypothesis is that combining oral melatonin with standard treatment can reduce the length of hospital stay as compared to standard of care alone. The control group will receive standard treatment (antibiotic) while the intervention group will receive standard treatment plus melatonin for 14 days.
Where, as registered
No US site; Pakistan (1).
RecruitingNCT06996171
Comparative Efficacy of Magnesium Supplement and Melatonin Congener in Young Adults With Primary Insomnia
No phase
CMH Kharian Medical College
About 60 people
Started May 5, 2025
In plain words A study of melatonin in people 18 to 40, run by CMH Kharian Medical College. It plans to enroll about 60 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 40. Conditions: Primary Insomnia.
Age 18-40 years
Gender: Male and Females (Non-pregnant \& Non lactating)
Diagnosed cases of primary insomnia according to following criteria:
Difficulty falling asleep, staying asleep or nonrestorative sleep
3 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Magnesium glycinate; Melatonin
Registered summary
Sleep is essential for our overall health and well-being, much like food and water. It plays a vital role in numerous bodily functions. Many studies have been conducted to determine the efficacy of melatonin congeners and Mg supplements in patients with insomnia separately. This study aims to compare the efficacy of melatonin and magnesium supplements in young adults with primary insomnia. Most insomnia studies focus on older adults or individuals with comorbidities. Targeting otherwise healthy young adults brings age-specific relevance and novel insight.
Where, as registered
No US site; Pakistan (1).
RecruitingNCT07036796
Effect of Melatonin in Patients With Diabetic Peripheral Neuropathy
Phase 2
Ain Shams University
About 60 people
Started Jul 4, 2025
In plain words A Phase 2 study of melatonin in people 40 to 75, run by Ain Shams University. It plans to enroll about 60 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 40 to 75. Conditions: Diabetic Peripheral Neuropathy; Diabetic Neuropathy; Diabetic Peripheral Neuropathy in Type 2 Diabetic Patients.
Patients aged 40-75 years diagnosed with type 2 DM.
Diabetes duration at least 1 year.
Patients diagnosed with diabetic peripheral neuropathy.
Stable antidiabetic medication for at least 1 month before enrollment and during the trial
The exclusion criteria are on the listing.
What it tests, as registered
Melatonin
Registered summary
The aim of the current study is to measure the effect of melatonin as adjunct therapy on oxidative stress, inflammatory markers and clinical outcome in type 2 diabetic patients with diabetic peripheral neuropathy.
Where, as registered
No US site; Egypt (1).
RecruitingNCT07307677
Melatonin & Metformin on Clinical & Biochemical Parameters in Insulin Resistant PCOS Compared to Metformin
No phase
Mst.Sumyara Khatun
About 60 people
Started Mar 11, 2025
In plain words A study of melatonin in female participants 18 to 35, run by Mst.Sumyara Khatun. It plans to enroll about 60 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists female participants 18 to 35. Conditions: PCOS(Insulin Resistant).
Diagnosed case of PCOS according to Rotterdam criteria
Women of age 18-35 years
Insulin resistance (HOMA-IR >2.6)
The exclusion criteria are on the listing.
What it tests, as registered
Metformin 500mg; Melatonin 3mg
Registered summary
Women with polycystic ovary syndrome with HOMA-IR \>2.6 fulfilling inclusion and exclusion criteria will be randomly allocated into two groups:experimental group: A (Melatonin 3mg and Metformin 500mg) and control group: B (Metformin 500mg). Each group will be contained 30 selected patients. Group B:Tab. Metformin (500mg) once daily for 7days followed by twice daily for next 7 days followed by thrice daily for next 10 weeks. Outcome variables will be measured after three months, will be meticulously recorded for analysis and comparison.
Where, as registered
No US site; Bangladesh (1).
RecruitingNCT07850934
Effect of Melatonin on Pulmonary Hypertension in Full Term Neonates
No phase
Ain Shams University
About 52 people
Started Jul 1, 2025
In plain words A study of melatonin in people of any age, run by Ain Shams University. It plans to enroll about 52 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people of any age. Conditions: Congenital Peumonia; Persistent Pulmonary Hypertension of Newborn; Congenital Diaphragmatic Hernia.
Term neonates with gestational age ≥ 37 weeks.
Mean Pulmonary artery pressure greater than 25mmHg with clinical manifestations as tachypnea, tachycardia, hypoxemia and hypotension
The exclusion criteria are on the listing.
What it tests, as registered
Melatonin; nitric oxide generator
Registered summary
The aim of the study 1. To evaluate safety and efficacy of melatonin as an adjuvant therapy to inhaled nitric oxide generated by NO generator in the treatment of pulmonary hypertension in full term neonates. 2. To assess the effect of inhaled nitric oxide and melatonin on cerebral perfusion.
Where, as registered
No US site; Egypt (1).
RecruitingNCT06380491
Melatonin's Effect on Nighttime Blood Pressure and Sleep in OSA Patients (MEBP-OSA)
Phase 4
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
About 50 people
Started Jun 22, 2023
In plain words A Phase 4 study of melatonin in people 18 to 60, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran. It plans to enroll about 50 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 60. Conditions: Obstructive Sleep Apnea of Adult.
Polisomnographic diagnosis of Obstructive Sleep Apnea
Non-dipping blood pressure on Ambulatory blood pressure monitoring (ABPM):
The exclusion criteria are on the listing.
What it tests, as registered
Melatonin 3 MG Oral Tablet
Registered summary
The goal of this clinical trial is to learn if melatonin works to treat comorbid insomnia in adults with OSA and nocturnal non-dipping blood pressure pattern. The main question it aims to answer is: Does melatonin maintain sleep during night and recover the dipping blood pressure pattern?
Where, as registered
No US site; Mexico (1).
RecruitingNCT06846086
Cardioprotective Effects of Melatonin in Patients With Cardiomyopathy
Phase 3
Tanta University
About 46 people
Started Feb 20, 2025
In plain words A Phase 3 study of melatonin in people 18 and older, run by Tanta University. It plans to enroll about 46 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 and older; healthy volunteers accepted. Conditions: Cardiomyopathies.
Adult patients (≥18 years) with a confirmed diagnosis of cardiomyopathy based on clinical, echocardiographic, or imaging findings. .
Stable condition on standard cardiomyopathy medications (e.g., ACE inhibitors, beta-blockers).
Ability to provide informed consent.
The exclusion criteria are on the listing.
What it tests, as registered
Melatonin 10 MG; Placebo
Registered summary
The aim of current study is to: Evaluate the cardioprotective effects of melatonin in patients with cardiomyopathy.
Where, as registered
No US site; Egypt (1).
RecruitingNCT05713877
Melatonin for Treatment of Delirium in Critically Ill Adult Patients
Phase 2
Ciusss de L'Est de l'Île de Montréal
About 30 people
Started Feb 1, 2023
In plain words A Phase 2 study of melatonin in people 18 and older, run by Ciusss de L'Est de l'Île de Montréal. It plans to enroll about 30 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 and older. Conditions: Delirium.
Patients aged 18 years or older admitted to the intensive care unit;
Anticipated ICU stay > 48 hours;
ICDSC score greater than or equal to 4 for a maximum of 48 hours prior to randomization.
The exclusion criteria are on the listing.
What it tests, as registered
Melatonin; Placebo
Registered summary
The purpose of this study is to determine the feasibility of conducting a randomized controlled trial (RCT) with melatonin for treatment of delirium in critically ill adult patients. From a feasibility perspective, the investigators believe that the proposed design will achieve the minimum enrollment rate necessary to conduct a future RCT on a larger scale.
Where, as registered
No US site; Canada (1).
Not yet recruitingNCT04631341
Melatonin and Risk Of Cardiovascular Events And Malignant Tumors In The Elderly
No phase
RenJi Hospital
About 10,000 people
Starts Jan 1, 2021 (estimated)
In plain words A study of melatonin in people 60 to 74, run by RenJi Hospital. It plans to enroll about 10,000 people and lists no sites yet.
Who it lists and where
Who the trial lists, as registered
Lists people 60 to 74; healthy volunteers accepted. Conditions: Cardiovascular Diseases.
Queue members;
Han nationality;
Between 60-74 years old, no gender limit;
Women are in menopause;
4 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Melatonin
Registered summary
Cardiovascular diseases and tumors seriously threaten human health. There are many risk factors that affect the occurrence and death of cardiovascular diseases and malignant tumors. In addition to genetic and congenital factors, it also includes bad lifestyles, such as smoking, drinking, abnormal metabolism, excessive stress, etc. Many factors such as excessive stress and staying up late can cause abnormal circadian rhythms. The regulation of circadian rhythm is likely to be a key key to the early prevention of cardiovascular diseases and tumors. The full summary is on the listing.