Not yet recruitingPHASE3INTERVENTIONAL

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

This study is investigating if a specific children's melatonin medicine, called pediatric prolonged-release melatonin (PedPRM), can help children and teenagers aged 2 to 18 who have Post-Traumatic Stress Disorder (PTSD) and significant sleep problems. Many children with PTSD struggle with sleep, including difficulty falling asleep, waking up often, and nightmares. Currently, there aren't many recommended treatments for these sleep issues in young people with PTSD, even though they can greatly affect their daily life and recovery. The study will compare PedPRM to a placebo (a dummy pill) to see if it improves sleep, reduces PTSD symptoms, and helps with their daily activities. Participants will be carefully monitored for effects on their well-being, and potentially for their caregivers' well-being too.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

University Hospital, Strasbourg, France

Enrolment target

120

Start

01 Jan 2027

Estimated completion

01 Jun 2029

Post-traumatic Stress Disorder (PTSD)Current Significant Sleep Disturbances

What is this study about?

When children and teenagers experience something very upsetting or traumatic, they can sometimes develop Post-Traumatic Stress Disorder (PTSD). A common and difficult part of PTSD for young people is having serious sleep problems, like finding it hard to fall asleep, waking up many times during the night, waking up too early, or having lots of bad dreams. More than half of children with PTSD still have these sleep issues a year after the traumatic event.

At the moment, there's no widely recommended best treatment, especially no specific medicines, for these sleep problems in children and teenagers with PTSD. This is a big challenge because poor sleep can really affect a child’s daily life, their mood, and their overall mental health. If these sleep issues aren't sorted out, they can make anxiety worse, make PTSD last longer, and even make other treatments, like talking therapies, less effective.

We've previously seen that this special children's melatonin medicine, PedPRM, helped improve sleep in children with autism spectrum disorder. It also had positive effects on their daily behaviour, including anxiety. This new study is the first of its kind to test if PedPRM can help children and teenagers with PTSD who are struggling with sleep. We want to see if it can improve their sleep, reduce their PTSD symptoms, help with their daily activities, and also have a positive effect on their parents or caregivers.

Key takeaways

Study for children (2-18) with PTSD and significant sleep issues.
Compares a special melatonin medicine (PedPRM) to a dummy pill.
Aims to improve sleep, reduce PTSD symptoms, and help daily function.
No proven treatments currently for these specific sleep problems.
Contribution to medical knowledge about children's mental health.

Who may be eligible?

This study is looking for children and teenagers between 2 and 17 and a half years old who have been diagnosed with Post-Traumatic Stress Disorder (PTSD).

To join, they must also be having significant sleep problems for at least three months. This could mean sleeping for less than 6 hours straight, taking more than 30 minutes to fall asleep, or having a nightmare disorder. They also need to have tried and not responded to at least four weeks of good sleep practices (like having a regular bedtime routine).

There are also some reasons why someone couldn't join. For example, if they have other serious health problems, are allergic to melatonin or lactose, are pregnant or breastfeeding, have another significant sleep disorder (like severe sleep apnea), or have taken certain other medications recently. They also can't have started a new talking therapy for sleep or mood within the last six weeks, or participated in another study recently.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child aged between 2 and 17 and a half years old?
Has your child been diagnosed with Post-Traumatic Stress Disorder (PTSD)?
Does your child have significant sleep problems (e.g., struggles to fall asleep, wakes often, or has nightmares)?
Have good sleep routines not helped your child's sleep after at least 4 weeks?
Is your child generally in good health otherwise, without other severe sleep conditions like severe sleep apnea?
Has your child not taken melatonin in the last 2 weeks and not started talking therapy for sleep/mood in the last 6 weeks?

Answer every question to see your result.

What does participation involve?

If you or your child decide to take part, you would be involved in a clinical trial. This means your child would either receive the special melatonin medicine (PedPRM) or a dummy pill (placebo). Neither you nor the study team would know which one your child is taking (this is called 'double-blind'). You would have regular visits to the study clinic where your child's sleep, mood, and PTSD symptoms would be carefully checked. You would likely fill out questionnaires and your child might have some assessments. There would be a period of taking the medication, followed by careful monitoring. The total duration of participation in the study is not specified but clinical trials often last several months, with follow-up appointments.

Potential risks and benefits

Participating in this study might offer a chance for your child's sleep to improve, which could then help with their PTSD symptoms and overall daily life. There's also the benefit of contributing to our understanding of how best to help children and teenagers with PTSD and sleep difficulties. However, there's no guarantee that your child will receive the active medicine or that it will work for them. As with any medicine, there's a chance of side effects, although melatonin is generally considered safe. You will be fully informed of any known risks. You are always free to withdraw from the study at any time, for any reason, without it affecting your child's medical care.

Locations (1)

Hôpitaux Universitaires de Strasbourg
Verified postcode
Strasbourg, France

Common questions

What is PTSD?

PTSD stands for Post-Traumatic Stress Disorder. It's a mental health condition that can develop after someone experiences or witnesses a terrifying event. Symptoms can include flashbacks, nightmares, severe anxiety, and uncontrollable thoughts about the event.

What is melatonin?

Melatonin is a natural hormone your body makes that helps control your sleep-wake cycle. The type used in this study is a special child-friendly version that releases slowly over time.

Will my child definitely get the real medicine?

No, this is a 'randomized, placebo-controlled' study. This means your child will be randomly assigned to either receive the active melatonin medicine or a placebo (a dummy pill with no active ingredient). Neither you nor the doctors will know which one they are taking.

What does 'prolonged-release' mean for melatonin?

It means the melatonin is designed to be released slowly into the body over several hours, rather than all at once. This helps it to work throughout the night.

What is a 'clinical trial'?

A clinical trial is a research study that looks at new ways to prevent, detect, or treat diseases. It's a careful way to find out if a new treatment is safe and effective.

How to find out more

Julie ROLLING, MD

julie.rolling@chru-strasbourg.fr 03 88 11 54 82 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.