Status:
RECRUITING
Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia
Lead Sponsor:
Lone Baandrup
Collaborating Sponsors:
Danish Center for Sleep Medicine
Region Capital Denmark
Conditions:
Psychiatric Disorders
Insomnia
Eligibility:
All Genders
16-64 years
Phase:
PHASE2
PHASE3
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 pl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2029
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT06062953
Start Date
September 18 2023
End Date
February 28 2029
Last Update
April 24 2025
Active Locations (1)
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1
Mental Health Center Copenhagen
Copenhagen NV, Denmark, 2400