Phase 3 Sleep Disorders Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People aged 16 to 64 years old
- People who have been diagnosed with a current or past mental or behavioural disorder that falls within specific recognised categories (confirm with trial site for the full list of qualifying diagnoses)
- People diagnosed with autism spectrum disorder or attention-related conditions who have previously been treated with melatonin
- Teenagers aged 16 to 17 who have already tried non-medication approaches for sleep problems — such as sleep hygiene education, weighted blankets, or similar products — without enough improvement
- People who have reported sleep difficulties at least three times per week over the past 3 months
- People whose sleep problems score 11 or higher on a standard sleep difficulty questionnaire called the Insomnia Severity Index
- Women who could become pregnant must have a negative pregnancy test at the start of the trial and must be using a highly effective form of contraception
- People who are able to give their informed consent to take part
Who may not be able to join:
- People currently being treated with melatonin or quetiapine
- People with a serious physical health condition
- People with a BMI of 35 or higher
- People who are currently breastfeeding
- People who have had alcohol or substance dependency within the last 3 months
- People who do not have adequate Danish language skills
- People who are not able to give informed consent
- People who have increased heart-related risks, based on risk factors, heart symptoms, or results from a heart tracing (ECG) done at the start of the trial
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Lone Baandrup, MD, Mental Health Center Copenhagen
Phone: +4591165903
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Insomnia severity
Can't join this trial?
Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.