Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia
Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia: a Randomized Clinical Trial
Lone Baandrup
255 participants
Sep 18, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria8
- 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
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Interventions
3-9 mg flexible dosing before bed time
50-150 mg flexible dosing before bed time
1-3 capsules flexible dosing before bed time
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06062953