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Could melatonin help kids with PTSD sleep better?

NCT ID NCT07418554

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether a slow-release form of melatonin can improve sleep in 120 children and adolescents (ages 2-17.5) with PTSD who have significant sleep disturbances. Participants will receive either melatonin or a placebo for 13 weeks. The study aims to see if melatonin increases total sleep time and reduces PTSD symptoms, daytime problems, and caregiver stress.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
prolonged-release melatonin
What this could lead to
If it works, this could provide a safe, effective treatment for sleep problems in children with PTSD, improving their daytime functioning and mental health.
What could go wrong
This is an early-stage trial with only 120 participants. Melatonin may not work for PTSD-related sleep issues, and individual results may vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Children and adolescents (2 -17.5 years) with: * A diagnosis of post-traumatic stress disorder (PTSD) as defined by DSM-5 (American Psychiatric Association, 2013) * Current significant sleep disturbances defined as ≤6 hours of continuous sleep and/or ≥0.5-hour sleep latency from lights-off on 3 out of 5 nights and/or nightmare disorder as defined by the International Classification of Sleep Disorders, Third Edition (ICSD-3, Sateia, 2014), for a minimum 3 months, based on parent report and patient medical history * No response to at least 4 weeks of sleep hygiene * Negative pregnancy test for females with childbearing potential * Written informed consent provided by both parents or a legal guardian, as well as the children / adolescents themselves, if possible * Stable doses of non-excluded medications for at least 3 months Exclusion Criteria: * Known systemic or severe acute disease whose care would hinder attendance at appointments * Pregnancy, breastfeeding * Known diagnosis of another significant sleep disorder (e.g., moderate to severe sleep apnea) * Treatment with any form of melatonin within 2 weeks prior to screening * Unresponsiveness to previous prolonged release melatonin within the 2 years prior to the study * Known allergy to melatonin or lactose * Use of prohibited medication (benzodiazepine, z-drug, antihistaminic, among others) within 2 weeks prior to screening * Start of a cognitive behavioural therapy (CBT) targeting sleep disturbances or mood disorders, within 6 weeks before study inclusion * Participation in a clinical trial within the last month prior to the study * Transmeridian travel (\> 2 time zones) within the month before the start of the study * Females not using contraceptives who are sexually active, pregnant, and/or breastfeeding * Other reasons: inability to receive clear information, inability to participate in the entire study, lack of coverage by the social security system, refusal to sign consent.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67091, France

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