Melatonin versus quetiapine in adolescents (MEL-QUE-A)
Key facts
- Phase
- Phase 2/3
This trial has no sites in United States.
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Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorTrial details
- Who runs it
- Region Hovedstaden
- Trial code
- EU 2024-519597-39-00
- Record updated
- 11 November 2026
- Original description
To examine the efficacy of melatonin or low-dose quetiapine versus placebo for treatment of insomnia.Read full original descriptionShow less
Efficacy of melatonin, low-dose quetiapine, or placebo in adolescents with psychiatric disorders and comorbid insomnia: a randomized clinical trial
To examine the efficacy of melatonin or low-dose quetiapine versus placebo for treatment of insomnia.
Inclusion: 16 to 17 years of age; ICD-10 diagnosis of a current or previous mental or behavioral disorder (F20-F69, F84, F90-F95); For the diagnoses F84 and F90 a previous period of treatment with melatonin is required; Self-reported sleep difficulties at least three times per week in the preceding 3 months; Insomnia Severity Index score ≥11; Non-pharmacological treatment options including sleep hygiene education, weighted blanket or other gravity products have been tested with insufficient effect; Women of childbearing potential: negative pregnancy test at baseline and use of highly effective contraception measures; Informed consent provided by both the minor and the legally designated representative.
Exclusion: Current treatment with melatonin or quetiapine; Increased cardiac risk as assessed by presence of cardiac risk factors, cardiac symptoms, or prolonged QT-interval at baseline electrocardiogram (ECG); Severe somatic comorbidity; BMI ≥ 35 kg/m2; Breastfeeding; Alcohol and/or substance dependency (F1X.2) within the last 3 months; Inadequate Danish language skills; Not able to make an informed consent.