Testing melatonin and low-dose quetiapine for insomnia in patients with psychiatric disorders
Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia: a Randomized Clinical Trial
This study is testing whether melatonin and a low dose of quetiapine can help people with psychiatric disorders sleep better compared to a placebo.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 255 (estimated) |
| Ages | 16 Years to 64 Years |
| Sex | All |
| Sponsor | University of Copenhagen Academic / other |
| Locations | 1 site (Copenhagen NV) |
| Trial ID | NCT06062953 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of melatonin and low-dose quetiapine compared to a placebo in treating insomnia among patients with psychiatric disorders. It is a randomized, blinded, three-armed, placebo-controlled trial designed to assess not only the improvement in sleep but also the overall symptom severity, sleep quality, psychosocial functioning, and subjective well-being of participants. Over a six-week treatment period, participants will receive either melatonin, quetiapine, or a placebo, followed by a brief tapering phase. The study aims to provide insights into how these treatments can alleviate insomnia in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16 to 64 with a diagnosed psychiatric disorder and self-reported sleep difficulties occurring at least three times a week.
Not a fit: Patients currently receiving treatment with melatonin or quetiapine, or those with severe comorbidities or substance dependency, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective treatment options for insomnia in patients with psychiatric disorders, improving their overall quality of life.
How similar studies have performed: Previous studies have shown promise in using melatonin for sleep disorders, but the combination with low-dose quetiapine in this specific population is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Copenhagen NV
- Mental Health Center Copenhagen — Copenhagen NV, Denmark (Recruiting)
Study contacts
- Principal investigator: Lone Baandrup, MD — Mental Health Center Copenhagen
- Study coordinator: Lone Baandrup, MD
- Email: lone.baandrup@regionh.dk
- Phone: +4591165903
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.