drugset / Trial / NCT06062953
Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia
Phase 2/3
Recruiting
255 enrolled
Lone Baandrup
Copenhagen Trial Unit, Center for Clinical Intervention Research · collabDanish Center for Sleep Medicine · collabMental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital · collabRegion Capital Denmark · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2023-09-18
- Primary completion
- 2029-02-28
- Completion
- 2029-02-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Melatonin | Small molecule | 3 mg | — |
| Subject | Melatonin | Small molecule | 9 mg | — |
| Subject | Quetiapine | Small molecule | 50 mg | — |
| Subject | Quetiapine | Small molecule | 150 mg | — |