Actively Recruiting
Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia
Led by Lone Baandrup · Updated on 2025-04-24
255
Participants Needed
1
Research Sites
284 weeks
Total Duration
On this page
Sponsors
L
Lone Baandrup
Lead Sponsor
D
Danish Center for Sleep Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 16 to 64 years
- ICD-10 diagnosis of a current or previous mental or behavioral disorder (F20-F69, F84, F90-F95)
- For diagnoses F84 and F90, prior treatment with melatonin is required
- For ages 16-17, non-drug treatments like sleep hygiene education or weighted blankets have been tried without sufficient effect
- Self-reported sleep difficulties at least three times per week over the last 3 months
- Insomnia Severity Index score of 11 or higher
- Women of childbearing potential must have a negative pregnancy test at baseline and use highly effective contraception
- Ability to provide informed consent
You will not qualify if you...
- Currently treated with melatonin or quetiapine
- Severe physical illness
- Body mass index (BMI) of 35 kg/m2 or higher
- Breastfeeding
- Alcohol or substance dependency within the last 3 months
- Insufficient Danish language skills
- Unable to provide informed consent
- Increased cardiac risk due to risk factors, symptoms, or prolonged QT interval on baseline ECG
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mental Health Center Copenhagen
Copenhagen NV, Denmark, 2400
Actively Recruiting
Research Team
L
Lone Baandrup, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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