Plain-English translation of NCT07472075 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.
This study is testing whether , a natural hormone that regulates sleep, can help people with bipolar disorder manage their mood and sleep better. About 200 people will take either or a placebo (inactive pill) every evening for 6 months. Neither the patients nor the doctors will know who is getting the real medication, which helps ensure the results are fair and unbiased.
Sleep problems are a major part of bipolar disorder and happen even when other treatments are working. Researchers believe that this medication might help regulate the body's natural sleep-wake cycle and improve mood stability, but this hasn't been carefully studied yet in bipolar disorder.
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You will visit the study clinic and then take a pill every evening at home for 6 months—either the active medication or a placebo. The study team will check in on how you're doing, track your mood and sleep, and monitor your overall well-being throughout the 6 months. You won't know whether you're getting the real medication or the placebo, but researchers will be available to answer questions and monitor your safety.
AI-generated summary from trial data · Jun 5, 2026 · Not medical advice
Denmark
Testing effectiveness
Sponsor
Lars Vedel Kessing
Enrollment target
~200 participants
Started
May 2026
Primary completion
June 2028
Age range
18 Years – 70 Years
Last updated on clinicaltrials.gov in May 2026.
Reach out to the team running this trial. Response times vary — some teams are faster than others.
Central contact
Lars Kessing
University hospital Bispebjerg and Frederiksberg Hospital
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.