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Efficacy of melatonin, low-dose quetiapine, or placebo in patients with psychiatric disorders and comorbid insomnia: a randomized clinical trial
EU CTIS ID: 2023-504728-24-00
What this study is testing
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.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Current treatment with melatonin or quetiapine
- Severe somatic comorbidity
- BMI ≥ 35 kg/m2
- Breastfeeding
- Alcohol and/or substance dependency (F1X.2) within the last 3 months
- Inadequate Danish language skills
See the full eligibility criteria
- 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
- Current treatment with melatonin or quetiapine
- 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
- Increased cardiac risk as assessed by presence of cardiac risk factors, cardiac symptoms, or prolonged QT-interval at baseline ECG
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.