Plain-English translation of NCT06226025 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 trial is testing whether —a common sleep supplement—combined with behavioral coaching about sleep habits can help people with bipolar disorder who naturally stay up late. Researchers believe that shifting your sleep schedule earlier might help improve mood and sleep quality. About 50 people will participate, with half receiving plus sleep coaching and half receiving placebo (a fake pill) plus standard sleep information.
Many people with bipolar disorder have a natural tendency to stay up late at night, which may worsen their mood symptoms. This study explores whether adjusting the body's internal clock earlier—using this medication paired with behavioral changes—could be a helpful new way to improve mood and sleep in bipolar disorder.
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You would take either or a placebo pill once daily for 28 days, starting in the afternoon or evening. Throughout the study, you'll work with a sleep coach on behavioral strategies to shift your sleep schedule earlier. You'll use a mobile app to track your progress and likely complete some questionnaires about your mood and sleep. The study team will measure changes in your sleep timing and depression symptoms before and after the treatment period.
AI-generated summary from trial data · Jun 2, 2026 · Not medical advice
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