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

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.