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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Melatonin; Quetiapine Fumarate

Criteria

Inclusion Criteria:

• 18 to 65 years of age

• ICD-10 diagnosis of a current or previous mental or behavioral disorder (F20-F69)

• 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

• 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