Protocol MelatoSom-Kids-PTSD: sleep disturbances in children and adolescents with post-traumatic stress disorder (PTSD) – a randomized double-blind placebo-controlled trial to investigate the efficacy of paediatric prolonged-release melatonin

<b>Introduction</b>: Sleep disorders in the insomnia spectrum, as well as nightmares, are among the most sensitive and persistent symptoms in children with post-traumatic stress disorder (PTSD). There is currently no reference treatment or specific pharmacological treatment recommendation on the management of sleep disturbances in children and adolescents suffering from PTSD, despite the fact that they have a significant effect on daytime functioning and overall mental health of children as well as on family's health and quality of life. In this respect, paediatric prolonged-release melatonin (PedPRM) has shown significant beneficial effects on insomnia disorders in children with autism spectrum disorders and positive effects on anxiety and depressive symptomatology. Our study will be the first randomized controlled trial to examine the efficacy of PedPRM melatonin on sleep disorders in children and adolescents with PTSD, as well as on PTSD symptoms, associated daytime functioning and overall mental health in these children and their caregivers.<b>Methods/design</b>: The MelatoSOM-Kids-PTSD study (French national hospital-based clinical research programme) will be a multi-centre prospective double-blind placebo-controlled parallel group clinical trial investigating the efficacy of paediatric prolonged-release melatonin to alleviate sleep disturbances in children and adolescents with PTSD (120 participants recruited over a 24-month period). The experimental group will be treated with active prolonged-release melatonin over 13 weeks (PedPRM). The control group will receive a placebo. The primary endpoint will be the difference in sleep diary derived total sleep time after 13 weeks of treatment in the PedPRM group versus placebo group. Secondary endpoints will be the differences in objective sleep quality parameters and daytime functioning before and after treatment, in children with PTSD and their caregivers.<b>Discussion</b>: This paper describes the MelatoSOM-Kids-PTSD protocol, which will evaluate the effectiveness of melatonin, a treatment that has already demonstrated an excellent benefit-risk ratio in the paediatric population over 4 years.