NCT06062953

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 255 (estimated)
• Sponsor: Lone Baandrup · Academic / Other
• Sex: All
• Age: 16 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psychiatric Disorders
• Insomnia

Interventions

Type	Name	Description
DRUG	Melatonin	3-9 mg flexible dosing before bed time
DRUG	Quetiapine	50-150 mg flexible dosing before bed time
DRUG	Placebo	1-3 capsules flexible dosing before bed time

Timeline

• Start date: 2023-09-18
• Primary completion: 2029-02-28
• Completion: 2029-02-28
• First posted: 2023-10-02
• Last updated: 2025-04-24

Locations

1 site across 1 country: Denmark