Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia

Launched by LONE BAANDRUP · Sep 25, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how effective melatonin and low-dose quetiapine are in helping people with psychiatric disorders who also struggle with insomnia. Essentially, the study aims to see if these treatments can improve sleep quality, reduce overall symptoms of mental health issues, and enhance well-being compared to a placebo (a harmless sugar pill). Participants will be treated for six weeks with either melatonin, quetiapine, or the placebo, followed by a short period of gradually reducing the treatment.

To be eligible for this trial, participants must be between 18 and 65 years old and have a diagnosed mental or behavioral disorder. They should also experience sleep difficulties at least three times a week for the past three months. Women who can become pregnant will need to confirm they are not pregnant and use effective birth control. It's important to note that individuals currently taking melatonin or quetiapine, or who have certain health issues, may not qualify for the study. If you decide to participate, you'll be contributing to valuable research that may help improve treatments for insomnia in people with psychiatric conditions.

Gender

ALL

Eligibility 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