- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06062953
Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia (MEL-QUE)
Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia: a Randomized Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Lone Baandrup, MD
- Phone Number: +4591165903
- Email: lone.baandrup@regionh.dk
Study Locations
-
-
-
Copenhagen NV, Denmark, 2400
- Recruiting
- Mental Health Center Copenhagen
-
Contact:
- Ursula Brinck-Claussen, MD
- Phone Number: +4520483136
- Email: ursula.oedum.brinck-claussen@regionh.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
1-3 capsules flexible dosing before bed time
|
Experimental: Melatonin
|
3-9 mg flexible dosing before bed time
|
Experimental: Quetiapine
|
50-150 mg flexible dosing before bed time
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insomnia severity
Time Frame: 6 weeks
|
Insomnia Severity Index, range 0-28, higher is worse
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical global impression (CGI)
Time Frame: 6 weeks
|
Clinical global impression: Severity, range 0-7, higher is worse
|
6 weeks
|
Subjective sleep quality
Time Frame: 6 weeks
|
Pittsburgh Sleep Quality Index, range 0-21, higher is worse
|
6 weeks
|
Psychosocial functioning
Time Frame: 6 weeks
|
Personal and Social Performance Scale, range 1-100, higher is better
|
6 weeks
|
Patient-reported subjective well-being
Time Frame: 6 weeks
|
WHO-5 well-being index, range 0-100, higher is better
|
6 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective sleep quality (polysomnography)
Time Frame: 6 weeks
|
Total sleep time in minutes, higher is better
|
6 weeks
|
Circadian rhythmicity (actigraphy)
Time Frame: 6 weeks
|
Interdaily stability which quantifies the invariability from day to day, i.e., the predictability of the 24 h rest-activity pattern.
This index will be 1 for perfect interdaily stability and thus lower values reflect higher variability between the observed days
|
6 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lone Baandrup, MD, Mental Health Center Copenhagen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Nervous System Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Problem Behavior
- Sleep Initiation and Maintenance Disorders
- Mental Disorders
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Protective Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Antidepressive Agents
- Antioxidants
- Melatonin
- Quetiapine Fumarate
Other Study ID Numbers
- 2023-504728-24-00
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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