Melatonin or low-dose quetiapine for insomnia in people with psychiatric disorders
Compares melatonin, low-dose quetiapine and placebo for long-lasting insomnia alongside psychiatric treatment.
Key facts
- Who runs it
- Region Hovedstadens Psykiatriske
- Where
- Denmark1 site in 1 countryChoose a country to see its sites
- Trial code
- Registry title
- Efficacy of melatonin, low-dose quetiapine, or placebo in patients with psychiatric disorders and comorbid insomnia: a randomized clinical trial
- Status
- Recruiting
- Phase
- Phase 2/3
- People taking part
- 255 people, planned
- Started
- 15 Sept 2023
- Expected to end
- 28 Feb 2029
- Type of study
- Interventional
- Record updated
- 17 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a mental or behavioral disorder who also have long-lasting trouble sleeping (insomnia). It compares melatonin, low-dose quetiapine and a dummy pill (placebo) added to usual treatment.
- Age
- 18 to 64 years
- Sex
- All sexes
- Disease stage
- A current or previous mental or behavioral disorder (ICD-10 F20-F69, F84, F90-F95). Sleep difficulties at least three times per week in the preceding 3 months. Insomnia Severity Index score ≥11.
- Earlier treatment
- People with the diagnoses F84 or F90 must have had a previous period of treatment with melatonin. People currently taking melatonin or quetiapine cannot join.
Main reasons for not taking part
- Current treatment with melatonin or quetiapine
- Severe other physical illness
- BMI ≥ 35 kg/m2
- Breastfeeding, or alcohol or drug dependency within the last 3 months
- Increased heart risk, including heart symptoms or a prolonged QT-interval on the baseline ECG (heart tracing)
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 18 to 64 years of age
- ICD-10 diagnosis of a current or previous mental or behavioral disorder (F20-F69, F84, F90-F95)
- For the diagnoses F84 and F90 a previous period of treatment with melatonin is required
- 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
Who cannot take part
- 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 (F1X.2) within the last 3 months
- Inadequate Danish language skills
- Not able to make an informed consent
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The objective of the trial is to examine the efficacy of melatonin versus low-dose quetiapine versus placebo as augmentation to treatment as usual in patients with psychiatric disorders and comorbid chronic insomnia.
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
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- Efficacy of melatonin, low-dose quetiapine, or placebo in patients with psychiatric disorders and comorbid insomnia: a randomized clinical trial
- Plain-language title
- Melatonin or low-dose quetiapine for insomnia in people with psychiatric disordersGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from 2023-504728-24-00, who can take part
- Record updated
- 17 June 2026