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

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.