Clinical trial NCT06062953: Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia
Official title: Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Psychiatric Disorders
Insomnia
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Danish Center for Sleep Medicine
name: Region Capital Denmark
name: Copenhagen Trial Unit, Center for Clinical Intervention Research
name: Mental Health Services in the Capital Region, Denmark
First posted: 2023-10-02
Enrollment: 255
Sex: ALL
Minimum age (years): 16
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Insomnia severity
timeFrame: 6 weeks
Secondary outcomes:
measure: Clinical global impression (CGI)
timeFrame: 6 weeks
measure: Subjective sleep quality
timeFrame: 6 weeks
measure: Psychosocial functioning
timeFrame: 6 weeks
measure: Patient-reported subjective well-being
timeFrame: 6 weeks
Other outcomes:
measure: Objective sleep quality (polysomnography)
timeFrame: 6 weeks
measure: Circadian rhythmicity (actigraphy)
timeFrame: 6 weeks
Locations:
city: Copenhagen NV
country: Denmark
facility: Mental Health Center Copenhagen
Study officials:
affiliation: Mental Health Center Copenhagen
name: Lone Baandrup, MD
role: PRINCIPAL_INVESTIGATOR
References: