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Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia

NCT06062953 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2025-04-24

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Danish Center for Sleep Medicine

    collaborator OTHER

  • Region Capital Denmark

    collaborator OTHER

  • Copenhagen Trial Unit, Center for Clinical Intervention Research

    collaborator OTHER

  • Mental Health Services in the Capital Region, Denmark

    collaborator OTHER

  • Lone Baandrup

    lead OTHER

Principal Investigators

  • Lone Baandrup, MD · Mental Health Center Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-18
Primary Completion
2029-02-28
Completion
2029-02-28

Countries

  • Denmark

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06062953 on ClinicalTrials.gov