Clin2
NCT06062953Possibly a fitRecruiting

Melatonin or low-dose quetiapine for insomnia in psychiatric disorders

Psychiatric DisordersInsomnia

Treatments studied

Part of Brain & nervous system, Mental health clinical trials.

This study tests if melatonin, a low dose of quetiapine, or a placebo can help people with a psychiatric condition who also have trouble sleeping. You may qualify if you have insomnia at least 3 times a week and your sleep problem has lasted 3 months or longer.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 2/Phase 3
Enrollment
255 people
Ages
16 years to 64 years
Study type
Interventional

Who can take part

  • You are between 16 and 64 years old.
  • You have a current or past mental health diagnosis (such as depression, anxiety, bipolar, ADHD, or autism).
  • You have had trouble sleeping at least 3 times a week for the last 3 months.
  • You have an Insomnia Severity Index score of 11 or higher.
  • You are not currently taking melatonin or quetiapine.
  • If you are a woman able to become pregnant, you must have a negative pregnancy test and use effective birth control.
  • You do not have severe health conditions, a BMI of 35 or higher, or recent alcohol/substance dependency.
  • You can understand and speak Danish well enough to give consent.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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