Condition: Major Depressive Disorder(MDD) · Insomnia Comorbid to Psychiatric Disorder · Sponsor: Unity Health Toronto
The goal of this clinical trial is to learn if Lemborexant works to treat residual insomnia in adults with depression that is being treated. It will also learn about how practical, tolerable, and effective Lemborexant is. The main questions it aims to answer are: * Does Lemborexant help participants improve sleep and reduce insomnia symptoms? * How practical is it to use Lemborexant (how many participants join, drop out, and follow the study rules)? How do participants feel about using it (based on surveys and interviews)? Researchers will compare Lemborexant to a placebo (a look-alike substance that contains no drug) to see if Lemborexant works to treat residual insomnia in adequately treated major depressive disorder. Participants will: * Take Lemborexant or a placebo every day for 6 weeks (2 weeks at 5 mg then 4 weeks at 10 mg) * Complete clinical assessments and in-person study visits * Maintain a digital sleep diary and complete daily and weekly self-report ecological momentary assessments (EMAs) * Use a wearable device which will be used to collect and monitor physiological data
This description comes directly from the study's public registry record.
Venkat Bhat, MD, MSc · 416-360-4000 · venkat.bhat@unityhealth.to
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| St. Michael's Hospital, Unity Health Toronto | Toronto, Ontario, Canada | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06843187