Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia
Status:
Recruiting
Trial end date:
2026-02-28
Target enrollment:
Participant gender:
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Lone Baandrup
Collaborators:
Copenhagen Trial Unit, Center for Clinical Intervention Research Danish Center for Sleep Medicine Mental Health Services in the Capital Region, Denmark Region Capital Denmark