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

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia: a Randomized Clinical Trial

Conditions
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Psychiatric Disorders, Insomnia

Intervention / Treatment
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* Drug: Melatonin
* Drug: Quetiapine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 65 years of age ICD-10 diagnosis of a current or previous mental or behavioral disorder (F20-F69) 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin<br> | Drug: Melatonin<br>* 3-9 mg flexible dosing before bed time<br>|
| Experimental: Quetiapine<br> | Drug: Quetiapine<br>* 50-150 mg flexible dosing before bed time<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 1-3 capsules flexible dosing before bed time<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia severity | Insomnia Severity Index, range 0-28, higher is worse | 6 weeks | 

Secondary Outcome Measures

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