Testing melatonin and low-dose quetiapine for insomnia in patients with psychiatric disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Lemborexant for insomnia in people with psychiatric conditions

  We will try lemborexant for 8 weeks in adults with psychiatric disorders who have insomnia to see if it helps them sleep better and is safe.

  Recruiting at 9 sites Shanghai Mental Health Center · Suzhou, Jiangsu and 8 other locations · NCT07417813

• SleepCogni for children with chronic insomnia

  A handheld SleepCogni device is tested to see if it helps kids aged 6–16 with chronic insomnia sleep better.

  Recruiting Sheffield Children's NHS Foundation Trust · Sheffield · NCT07926724

• Music therapy after stroke

  This trial tests whether adding music therapy to standard care helps stroke patients sleep better and feel less anxious or depressed while in the hospital.

  Recruiting Universidad de Granada · Granada, Granada · NCT07899034

• Remote ischemic conditioning for post-stroke insomnia

  A 136-person, randomized study will test whether a non-invasive arm-cuff procedure done twice daily for 90 days can improve sleep after a first ischemic stroke in adults 18–80.

  Recruiting Sichuan Academy of Medical Sciences · Chengdu, Sichuan · NCT07874594

• Nurse-guided app-based brief behavioral therapy for insomnia in older adults

  Aging adults with insomnia will be asked to try a nurse-supported, smartphone app therapy for four weeks to see if it helps with sleep.

  Recruiting Taipei Medical University · Taipei · NCT07842250

• Three rTMS approaches to lessen insomnia-related pain after exercise-induced muscle soreness

  This study tests whether three different rTMS approaches can reduce pain sensitivity and improve recovery in adults with insomnia after inducing muscle soreness from exercise.

  Recruiting The Hong Kong Polytechnic University · Hong Kong · NCT07827677

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.