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Not Yet RecruitingNCT07418554

Pediatric, prolonged released melatonin for PTSD

This study is not yet recruiting in France. It is testing pediatric, prolonged released melatonin for PTSD.

PTSD, PTSD (PTSD), ...DrugFrom 2 Years to 18 Years
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In plain English

Key information made simple

What is this study testing?

This study is testing whether pediatric, prolonged released melatonin may be useful for adolescents experiencing ptsd.

What would participation involve?

Participants may receive pediatric, prolonged released melatonin, complete questionnaires or follow-up assessments, attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in France.

Who is it mainly for?

This study appears to be mainly for adolescents with ptsd. Because it involves minors, a parent or guardian may need to be involved.

What should you check before joining?

Ask about the dose, safety monitoring, and possible side effects, whether there is placebo, randomization, or a comparison group, how many visits or travel steps are needed, what role parents or guardians have in the process.

What to expect

Your next step

The official record does not clearly describe the visit format, so the practical details are best checked directly in the source. Participation appears to involve study activities and follow-up chosen by the research team. The main fit and exclusions are best confirmed in the eligibility section of the official record. The phase details are not clearly stated here.

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateNot clearly listed
Recruitment status
Not Yet Recruiting
Estimated enrollment
120
Sponsor
University Hospital, Strasbourg, France
Sponsor type
Hospital / academic medical center
Study type
Drug
Intervention type
Medication / drug
Study phase
PHASE3Usually a larger study designed to confirm effectiveness and safety in a broader group.
Locations
France
Age range
From 2 Years to 18 Years
Official registry ID
NCT07418554
Official title
Sleep Disturbances in Children and Adolescents With Post-traumatic Stress Disorder (PTSD): a Randomized Double-blind Placebo-controlled Trial to Investigate the Efficacy of Pediatric Prolonged-release Melatonin
Official source
Official registry link

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Study ID: NCT07418554. We help you review the study, but cannot decide medical eligibility.
In practice

For you

Taking part may give access to a new approach being evaluated.

It requires regular follow-up, often through questionnaires or interviews.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

FAQ

Questions about this study

What is this study trying to understand?

Based on the public registry summary, this study is trying to understand: Among the most sensitive and persistent symptoms of post-traumatic stress disorder (PTSD) in children are sleep disturbances in the insomnia spectrum (sleep onset disturbances, fragmented sleep with multiple nocturnal awakening, early morning awakening) as well as nightmares,. The study team can confirm the exact objective and what it means for you.

Does this study involve a medication?

This appears to be a medication / drug study involving pediatric, prolonged released melatonin, Placebo. The listed phase is PHASE3. Ask the study team what that means in practice for safety, monitoring, and criteria.

Who might this study be for?

This study may concern people with ptsd; age range: From 2 Years to 18 Years. The criteria appear fairly specific, but you should not assume you are eligible. The study team must confirm diagnosis, age, exclusions, available locations, and next steps.

What would I likely need to do?

You may need to take a study treatment and have regular medical follow-up. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.

What side effects, interactions, or treatment changes should I check?

If the study involves a medication, ask whether it is already approved, experimental, or being tested for a new use. Check possible side effects, interactions with current treatment, dose changes, monitoring, and what happens if you feel worse. For any mental health study, also ask who to contact if you feel worse, whether participation may affect current treatment, whether you can stop, and who confirms eligibility.

Will I need to travel or attend in-person visits?

The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.

Who is behind this study?

This study is sponsored by University Hospital, Strasbourg, France, which appears to be a hospital or academic medical center. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.

Can I still join this study?

The registry indicates that this study has not started recruiting yet. You can check the planned start date and available contacts. The registry lists an estimated enrollment of 120 participants.

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