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Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia
Sponsor: Lone Baandrup
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.
Official title: Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia: a Randomized Clinical Trial
Key Details
Gender
All
Age Range
16 Years - 64 Years
Study Type
INTERVENTIONAL
Enrollment
255
Start Date
2023-09-18
Completion Date
2029-02-28
Last Updated
2025-04-24
Healthy Volunteers
No
Conditions
Interventions
Melatonin
3-9 mg flexible dosing before bed time
Quetiapine
50-150 mg flexible dosing before bed time
Placebo
1-3 capsules flexible dosing before bed time
Locations (1)
Mental Health Center Copenhagen
Copenhagen NV, Denmark