Insomnia, Psychiatric Disorders
Conditions
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.
Interventions
DRUGMelatonin
3-9 mg flexible dosing before bed time
DRUGQuetiapine
50-150 mg flexible dosing before bed time
DRUGPlacebo
1-3 capsules flexible dosing before bed time
Sponsors
Danish Center for Sleep Medicine
Region Capital Denmark
Copenhagen Trial Unit, Center for Clinical Intervention Research
Mental Health Services in the Capital Region, Denmark
Lone Baandrup
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia severity | 6 weeks | Insomnia Severity Index, range 0-28, higher is worse |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Denmark
Contacts
Primary ContactLone Baandrup, MD
Outcome results
None listed