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

Insomnia Clinical Trial

— MEL-QUE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06062953
• Other study ID #: 2023-504728-24-00
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: September 18, 2023
• Est. completion date: February 28, 2026

Study information

• Verified date: September 2023
• Source: University of Copenhagen
• Contact: Lone Baandrup, MD
• Phone: +4591165903
• Email: lone.baandrup[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 255
• Est. completion date: February 28, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Mental Disorders
• Problem Behavior
• Psychiatric Disorders
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Melatonin
3-9 mg flexible dosing before bed time
• Quetiapine
50-150 mg flexible dosing before bed time
• Placebo
1-3 capsules flexible dosing before bed time

Locations

Country	Name	City	State
Denmark	Mental Health Center Copenhagen	Copenhagen NV

Sponsors (5)

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

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Objective sleep quality (polysomnography)	Total sleep time in minutes, higher is better	6 weeks
Other	Circadian rhythmicity (actigraphy)	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
Primary	Insomnia severity	Insomnia Severity Index, range 0-28, higher is worse	6 weeks
Secondary	Clinical global impression (CGI)	Clinical global impression: Severity, range 0-7, higher is worse	6 weeks
Secondary	Subjective sleep quality	Pittsburgh Sleep Quality Index, range 0-21, higher is worse	6 weeks
Secondary	Psychosocial functioning	Personal and Social Performance Scale, range 1-100, higher is better	6 weeks
Secondary	Patient-reported subjective well-being	WHO-5 well-being index, range 0-100, higher is better	6 weeks