Clareo Health | 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
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
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
You may not be if
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.
