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

Phase 2

Recruiting

• Conditions: Psychiatric Disorders; Insomnia
• Interventions: Drug: Placebo; Drug: Melatonin; Drug: Quetiapine

• Registration Number: NCT06062953
• Lead Sponsor: Lone Baandrup

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-13
• Study Start: 2023-09-18
• Study First Submitted QC: 2023-09-25
• Study First Posted: 2023-10-02
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24
• Primary Completion: 2029-02-28
• Study Completion: 2029-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 255

Inclusion Criteria

• 16 to 64 years of age
• ICD-10 diagnosis of a current or previous mental or behavioral disorder (F20-F69, F84, F90-95)
• For the diagnoses F84 and F90 a previous period of treatment with melatonin is required
• For the 16-17 years old: Non-pharmacological treatment options including sleep hygiene education, weighted blanket or other gravity products have been tested with insufficient effect
• 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 within the last 3 months
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Melatonin	Melatonin	-
Quetiapine	Quetiapine	-

Primary Outcome Measures

Name	Time	Method
Insomnia severity	6 weeks	Insomnia Severity Index, range 0-28, higher is worse

Secondary Outcome Measures

Name	Time	Method
Clinical global impression (CGI)	6 weeks	Clinical global impression: Severity, range 0-7, higher is worse
Patient-reported subjective well-being	6 weeks	WHO-5 well-being index, range 0-100, higher is better
Subjective sleep quality	6 weeks	Pittsburgh Sleep Quality Index, range 0-21, higher is worse
Psychosocial functioning	6 weeks	Personal and Social Performance Scale, range 1-100, higher is better

Trial Locations

Locations (1)

Mental Health Center Copenhagen; 🇩🇰 Copenhagen NV, Denmark