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

Sponsor

Lone Baandrup (Other)

Overall Status

Recruiting

CT.gov ID

NCT06062953

Collaborator

Danish Center for Sleep Medicine (Other), Region Capital Denmark (Other), Copenhagen Trial Unit, Center for Clinical Intervention Research (Other), Mental Health Services in the Capital Region, Denmark (Other)

255

Enrollment

Location

Arms

29.4

Anticipated Duration (Months)

8.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psychiatric Disorders Insomnia	Drug: Melatonin Drug: Quetiapine Drug: Placebo	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

255 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 18, 2023

Anticipated Primary Completion Date :

Feb 28, 2026

Anticipated Study Completion Date :

Feb 28, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Melatonin	Drug: Melatonin 3-9 mg flexible dosing before bed time
Experimental: Quetiapine	Drug: Quetiapine 50-150 mg flexible dosing before bed time
Placebo Comparator: Placebo	Drug: Placebo 1-3 capsules flexible dosing before bed time

Arm

Intervention/Treatment

Experimental: Melatonin

Drug: Melatonin

3-9 mg flexible dosing before bed time

Experimental: Quetiapine

Drug: Quetiapine

50-150 mg flexible dosing before bed time

Placebo Comparator: Placebo

Drug: Placebo

1-3 capsules flexible dosing before bed time

Outcome Measures

Primary Outcome Measures

Insomnia severity [6 weeks]
Insomnia Severity Index, range 0-28, higher is worse

Secondary Outcome Measures

Clinical global impression (CGI) [6 weeks]
Clinical global impression: Severity, range 0-7, higher is worse
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
Patient-reported subjective well-being [6 weeks]
WHO-5 well-being index, range 0-100, higher is better

Other Outcome Measures

Objective sleep quality (polysomnography) [6 weeks]
Total sleep time in minutes, higher is better
Circadian rhythmicity (actigraphy) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mental Health Center Copenhagen	Copenhagen NV		Denmark	2400

Sponsors and Collaborators

Lone Baandrup
Danish Center for Sleep Medicine
Region Capital Denmark
Copenhagen Trial Unit, Center for Clinical Intervention Research
Mental Health Services in the Capital Region, Denmark

Investigators

Principal Investigator: Lone Baandrup, MD, Mental Health Center Copenhagen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lone Baandrup, Sponsor-investigator, University of Copenhagen

ClinicalTrials.gov Identifier:

NCT06062953

Other Study ID Numbers:

2023-504728-24-00

First Posted:

Oct 2, 2023

Last Update Posted:

Oct 2, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders

Study Results

No Results Posted as of Oct 2, 2023