Actively Recruiting
Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia: a Randomized Clinical Trial
Led by Lone Baandrup · Updated on 2025-04-24
255
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the effectiveness of melatonin and low-dose quetiapine compared to a placebo for treating insomnia in patients with psychiatric disorders. This randomized, blinded, placebo-controlled clinical trial aims to study how these treatments impact insomnia severity, overall symptom severity, sleep quality, psychosocial functioning, and subjective well-being. The study is investigator-initiated and designed to determine if melatonin or quetiapine shows superiority over placebo in this patient group. Participants will be randomly assigned to one of three groups receiving either melatonin (3-9 mg), low-dose quetiapine (50-150 mg), or placebo (1-3 capsules) taken before bedtime. The treatment period lasts six weeks, followed by a brief tapering off phase. Dosing is flexible within the specified ranges to accommodate individual needs. During the trial, participants will be assessed for insomnia severity, clinical global impression, subjective sleep quality, psychosocial functioning, and patient-reported well-being, all measured at six weeks. The study includes careful monitoring, and participants will provide informed consent prior to starting. The total participation duration includes treatment and follow-up assessments over the six-week period.
CONDITIONS
Brief 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...
- 16 to 64 years of age
- ICD-10 diagnosis of a current or previous mental or behavioral disorder (F20-F69, F84, F90-95)
- For diagnoses F84 and F90, previous treatment with melatonin is required
- For ages 16-17, non-drug treatments like sleep hygiene education or weighted blankets must have been tried without enough effect
- Self-reported sleep difficulties at least three times per week for the past 3 months
- Insomnia Severity Index score of 11 or higher
- Women of childbearing potential must have a negative pregnancy test and use effective contraception
- Informed consent provided
You will not qualify if you...
- Current treatment with melatonin or quetiapine
- Severe physical health problems
- Body mass index (BMI) of 35 kg/m2 or higher
- Breastfeeding
- Alcohol or substance dependency within the last 3 months
- Inadequate Danish language skills
- Unable to provide informed consent
- Increased cardiac risk based on symptoms, risk factors, or prolonged QT interval on ECG
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive melatonin, low-dose quetiapine, or placebo with flexible dosing before bedtime to treat insomnia associated with psychiatric disorders.
Weekly visits for up to 6 weeks
Trial Site Locations
Total: 1 location
1
Mental Health Center Copenhagen
Copenhagen NV, Denmark, 2400
Actively Recruiting
Research Team
L
Lone Baandrup, MD
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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