Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia
Key facts
- Where
- Copenhagen NV, DenmarkSee the site
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 16 and 64 years old?
Source: NCT06062953, who can take part
Where in Denmark
- Mental Health Center CopenhagenCopenhagen NV, DenmarkContact: Ursula Brinck-Claussen, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Lone Baandrup
- Trial code
- NCT06062953
- Record updated
- 24 April 2025
- Original description
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:Read full original descriptionShow less
Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia: a Randomized Clinical Trial
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.
Inclusion: 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: Current treatment with melatonin or quetiapine; Increased cardiac risk as assessed by presence of cardiac risk factors, cardiac symptoms, or prolonged QT-interval at baseline ECG; 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.