RecruitingPhase 2Phase 3NCT06062953

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


Sponsor

Lone Baandrup

Enrollment

255 participants

Start Date

Sep 18, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 16 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Melatonin, a drug called Placebo, and others for people with insomnia and psychiatric disorders. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMelatonin

3-9 mg flexible dosing before bed time

DRUGQuetiapine

50-150 mg flexible dosing before bed time

DRUGPlacebo

1-3 capsules flexible dosing before bed time


Locations(1)

Mental Health Center Copenhagen

Copenhagen NV, Denmark

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NCT06062953


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