Could melatonin help kids with PTSD sleep better?
NCT ID NCT07418554
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Current significant sleep disturbances are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can reassuring cues help military personnel with PTSD read emotions?
- Can talk therapies quiet the trauma of violence?
- Could pausing psychiatric pills boost PTSD therapy?
- Can emotional patterns reveal the true nature of teen trauma?
- Beta-Blocker may rewrite traumatic memories in PTSD
- Zapping the Brain's fear hub: a new hope for PTSD?