Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia
NCT ID: NCT06062953
Last Updated: 2025-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
255 participants
INTERVENTIONAL
2023-09-18
2029-02-28
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Melatonin
Melatonin
3-9 mg flexible dosing before bed time
Quetiapine
Quetiapine
50-150 mg flexible dosing before bed time
Placebo
Placebo
1-3 capsules flexible dosing before bed time
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
64 Years
ALL
No
Sponsors
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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
Lone Baandrup
OTHER
Responsible Party
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Lone Baandrup
Sponsor-investigator
Principal Investigators
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Lone Baandrup, MD
Role: PRINCIPAL_INVESTIGATOR
Mental Health Center Copenhagen
Locations
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Mental Health Center Copenhagen
Copenhagen NV, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-504728-24-00
Identifier Type: -
Identifier Source: org_study_id
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