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Melatonin versus quetiapine in adolescents (MEL-QUE-A)
EU CTIS ID: 2024-519597-39-00
What this study is testing
To examine the efficacy of melatonin or low-dose quetiapine versus placebo for treatment of 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
- 16 to 17 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
- Non-pharmacological treatment options including sleep hygiene education, weighted blanket or other gravity products have been tested with insufficient effect
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
- 16 to 17 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
- Non-pharmacological treatment options including sleep hygiene education, weighted blanket or other gravity products have been tested with insufficient effect
- Women of childbearing potential: negative pregnancy test at baseline and use of highly effective contraception measures
- Informed consent provided by both the minor and the legally designated representative
- 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 electrocardiogram (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, 0-17 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.