Quetiapine: 50-150 mg flexible dosing before bed time
Placebo: 1-3 capsules flexible dosing before bed time
Study summary
The goal of this investigator-initiated, randomized, blinded, 3-armed placebo-controlled, pragmatic, clinical superiority trial is to examine the efficacy of melatonin or low-dose quetiapine versus placebo for treatment of insomnia in patients with psychiatric disorders. The aims of the study are:
* To examine the efficacy of melatonin or low-dose quetiapine versus placebo for treatment of insomnia
* To examine how melatonin or low-dose quetiapine affects global symptom severity, sleep quality, psychosocial functioning and subjective well-being.
Participants will receive six weeks of treatment with either melatonin, quetiapine or placebo followed by a brief taper off.
Eligibility
Sex
ALL
Min age
16 Years
Max age
64 Years
Healthy volunteers
No
Inclusion Criteria:
* 16 to 64 years of age
* ICD-10 diagnosis of a current or previous mental or behavioral disorder (F20-F69, F84, F90-95)
* For the diagnoses F84 and F90 a previous period of treatment with melatonin is required
* For the 16-17 years old: Non-pharmacological treatment options including sleep hygiene education, weighted blanket or other gravity products have been tested with insufficient effect
* Self-reported sleep difficulties at least three times per week in the preceding 3 months
* Insomnia Severity Index score ≥11
* Women of childbearing potential: negative pregnancy test at baseline and use of highly effective contraception measures
* Informed consent
Exclusion Criteria:
* Current treatment with melatonin or quetiapine
* Severe somatic comorbidity
* BMI ≥ 35 kg/m2
* Breastfeeding
* Alcohol and/or substance dependency within the last 3 months
* Inadequate Danish language skills
* Not able to make an informed consent
* Increased cardiac risk as assessed by presence of cardiac risk factors, cardiac symptoms, or prolonged QT-interval at baseline ECG
Primary outcome measure(s)
Insomnia severity — 6 weeks Insomnia Severity Index, range 0-28, higher is worse
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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