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Melatonin

Clinical trials are investigating Melatonin in several patient groups, including people with insomnia, psychiatric disorders, children after surgery, newborns with brain injury, and patients with pain or mood disorders. These studies look at safety, effectiveness, and specific outcomes such as sleep, pain, mood, or disease progression.

Table of contents

Overview of the Melatonin trials

These clinical trials study Melatonin in many different patient groups and conditions, rather than in one single disease area.[1]

The studies include people with sleep problems, psychiatric disorders, pain, mood disorders, multiple sclerosis, cancer, and other conditions, as well as children and newborns in hospital settings.[1][2]

The trials use different designs, including randomized, double-blind, and placebo-controlled studies, which means participants are assigned by chance and neither the patient nor the study team may know which treatment is given.[1][2]

Sleep and psychiatry studies

Several trials focus on insomnia in people with psychiatric disorders, including adolescents and adults with ICD-10 psychiatric diagnoses and chronic insomnia.[1][6]

In these studies, Melatonin is compared with low-dose quetiapine and with placebo, and the main outcome is insomnia severity measured by the Insomnia Severity Index (ISI).[1][6]

Another study in major depressive episode with insomnia tests a 2×2 factorial design, which means two treatments are studied alone and together in different groups.[5]

That study measures depressive symptoms with the Montgomery-Åsberg Depression Rating Scale (MADRS) after 8 weeks and looks at the effect of prolonged-release Melatonin, active light therapy, or both.[5]

Idiopathic hypersomnia is also being studied, with a 6-week chronobiotherapy plan that combines evening Melatonin and morning bright light therapy.[10]

The main outcome in that study is the change in the Idiopathic Hypersomnia Severity Scale (IHSS), which measures how severe the sleepiness symptoms are.[10]

Studies in children after surgery and newborns

One Phase 3 trial studies Melatonin in children to prevent agitation after surgery and emergence delirium, which means confusion or restlessness as the child wakes up from anesthesia.[2]

This study gives Melatonin intravenously during surgery and measures emergence agitation as the primary outcome.[2]

Another early Phase 1 study looks at newborns with moderate-severe hypoxic-ischaemic encephalopathy, a serious brain injury caused by low oxygen and low blood flow around birth.[3]

That study focuses first on safety, including dose-limiting events, and also checks whether planned blood levels of Melatonin and alcohol are reached during the safety window.[3]

The trial also aims to find the recommended Phase 2 dose, which is the dose chosen for the next stage of research.[3]

Pain, neurological, and hormone-related studies

Two Phase 3 trials study chronic back pain and chronic low back pain, both comparing daily Melatonin with placebo for 6 weeks.[4][8]

These studies measure the change in average pain intensity over the past 7 days using a 0 to 10 Numeric Rating Scale (NRS), where higher numbers mean worse pain.[4][8]

One completed Phase 1/2 trial in primary progressive multiple sclerosis looked at Melatonin together with ocrelizumab and measured disease progression using disability and neurological function scales.[7]

The outcomes included the Kurtzke Expanded Disability Status Scale and the Multiple Sclerosis Functional Composite, which are tools used to measure disability and function in multiple sclerosis.[7]

A Phase 3 study in postmenopausal women tests a combination of DHEA and prolonged-release Melatonin for 12 weeks and measures sleep quality, mood, daytime sleepiness, and menopausal vasomotor symptoms such as hot flashes.[6]

Cancer and bipolar disorder studies

One Phase 3 trial studies Melatonin as adjuvant treatment in uveal melanoma, which means treatment given after the main therapy to help improve outcomes.[9]

The main outcome is whether participants remain free from metastases, meaning cancer spread to other parts of the body, 5 years after randomization.[9]

Another authorised trial studies bipolar disorder in a 6-month randomized trial comparing Melatonin with placebo.[11]

That study looks at mood stabilization using a mood instability score based on daily self-monitored mood data collected through the Monsenso system.[11]

The study also wants to learn whether the main effect is antimanic, antidepressant, or prevention of relapse, but the primary outcome is mood stabilization.[11]

Phases, outcomes, and study design

The trials cover a wide range of phases, from Phase 1 safety work in newborns to Phase 4 studies in psychiatric disorders and adolescent insomnia.[1][3][6][11]

Later-phase studies often compare Melatonin with placebo or another active treatment to see if it improves symptoms more than the comparison group.[1][4][5][9][11]

Primary outcomes vary by condition and include insomnia severity, pain intensity, depressive symptoms, emergence agitation, disease progression, mood stability, and metastasis-free survival.[1][2][4][5][7][9][11]

Some trials are designed as superiority studies, meaning they test whether Melatonin works better than placebo for a specific outcome.[4][8]

Who can participate and what is compared

Participation depends on the trial and the condition being studied, so each study has its own target population.[1][2][3][4][5][6][7][8][9][10][11]

Some studies compare Melatonin with placebo, while others compare it with low-dose quetiapine or use it together with other treatments such as active light therapy, DHEA, or ocrelizumab.[1][5][6][7][10][11]

Across the trial list, Melatonin is being studied as a possible help for sleep, pain, mood, agitation after surgery, neurological disease outcomes, and cancer-related outcomes.[1][2][4][5][7][9][10][11]

Trial ID Phase Condition studied Status Enrollment
2023-504728-24-00 Phase 4 Psychiatric disorder and insomnia Authorised 255
NCT05541276 Phase 3 Emergence delirium Suspended 676
2025-520538-49-00 Phase 1 Moderate-Severe Hypoxic-Ischaemic Encephalopathy Authorised 60
2023-503530-41-00 Phase 3 Chronic back pain Completed 220
2024-516371-32-00 Phase 3 Insomnia, depressive episode Authorised 184
2024-519597-39-00 Phase 4 Psychiatric disorder and insomnia in adolescents Authorised 255
2024-520234-30-00 Phase 3 Menopause, sleep disorders in the postmenopausal period Authorised 100
2024-514769-20-00 Phase 3 Chronic low back pain Authorised 240
NCT03540485 Phase 1/2 Primary progressive multiple sclerosis Completed 50
2022-500307-49-00 Phase 3 Uveal melanoma Authorised 100
2023-506663-33-00 Phase 2 Idiopathic hypersomnia Authorised 72
2025-523549-92-00 Low Intervention Bipolar disorder Authorised 200

FAQ

  • Who can take part in Melatonin clinical trials? It depends on the study. The trials include adults with insomnia, psychiatric disorders, chronic back pain, bipolar disorder, primary progressive multiple sclerosis, uveal melanoma, idiopathic hypersomnia, and postmenopausal women, as well as children after surgery and newborns with hypoxic-ischaemic encephalopathy.
  • What are the trials of Melatonin trying to find out? The main goals are to see whether Melatonin helps with sleep, pain, mood, agitation after surgery, or disease outcomes. Some trials also focus on safety and on finding the best dose for later studies.
  • What trial phases are being used? The studies include Phase 1, Phase 1/2, Phase 2, Phase 3, Phase 4, and one low-intervention trial. This shows that Melatonin is being tested in both early and later research settings.
  • Which conditions are being studied with Melatonin? The trials study insomnia, psychiatric disorders with insomnia, emergence delirium after surgery, moderate-severe hypoxic-ischaemic encephalopathy in newborns, chronic back pain, major depressive episode with insomnia, menopause-related sleep problems, primary progressive multiple sclerosis, uveal melanoma, idiopathic hypersomnia, and bipolar disorder.
  • What kinds of results are measured in these studies? The studies measure many outcomes, such as insomnia severity, pain scores, depression scores, mood stability, emergence agitation, sleep quality, symptom scales, disease progression, and metastasis-free survival. Some trials also measure safety outcomes, such as dose-limiting events and blood levels.

Ongoing Clinical Trials on Melatonin

  • Study on the Safety and Effectiveness of Melatonin and Ocrelizumab for Patients with Primary Progressive Multiple Sclerosis

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on Melatonin for Patients with Chronic Back Pain

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

Glossary

  • Randomized clinical trial: A study where participants are placed into groups by chance. This helps compare treatments fairly.
  • Placebo: A look-alike treatment with no active study drug. It helps show whether the study drug works better than no active treatment.
  • Phase 1: An early study phase that mainly looks at safety and dose.
  • Phase 2: A study phase that looks at whether the treatment may work and continues safety checks.
  • Phase 3: A larger study phase that compares the treatment with placebo or another treatment to confirm benefit and safety.
  • Phase 4: A later study phase done after a treatment is already being used more widely.
  • Primary outcome: The main result the trial is designed to measure.
  • Insomnia Severity Index (ISI): A questionnaire used to measure how severe insomnia is.
  • Numeric Rating Scale (NRS): A simple pain scale, often from 0 to 10, where higher numbers mean worse pain.
  • Montgomery-Åsberg Depression Rating Scale (MADRS): A scale used to measure the severity of depressive symptoms.
  • Metastasis-free survival: The length of time a person stays free from cancer spread to other parts of the body.
  • Dose-limiting events: Side effects or safety problems that may stop a dose from being increased.

References

  1. https://clinicaltrials.gov/study/2023-504728-24-00
  2. https://clinicaltrials.eu/trial/melatonin-and-sodium-chloride-for-preventing-agitation-and-delirium-after-surgery-in-children/
  3. https://clinicaltrials.gov/study/2025-520538-49-00
  4. https://clinicaltrials.gov/study/2023-503530-41-00
  5. https://clinicaltrials.gov/study/2024-516371-32-00
  6. https://clinicaltrials.gov/study/2024-519597-39-00
  7. https://clinicaltrials.gov/study/2024-520234-30-00
  8. https://clinicaltrials.gov/study/2024-514769-20-00
  9. https://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-melatonin-and-ocrelizumab-for-patients-with-primary-progressive-multiple-sclerosis/
  10. https://clinicaltrials.gov/study/2022-500307-49-00
  11. https://clinicaltrials.gov/study/2023-506663-33-00
  12. https://clinicaltrials.gov/study/2025-523549-92-00