Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia
Eligible age
16–64 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: Lone Baandrup
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Source: ClinicalTrials.gov · NCT06062953 · last updated 2025-04-24