Plain-English translation of NCT07494305 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 is a Phase 2 clinical trial testing a new medication called for adults experiencing depression related to bipolar I disorder. Half of the participants will receive the medication, and half will receive a placebo (inactive pill), so researchers can see if the treatment actually works. The study lasts 6 weeks and will help doctors understand whether this medication is safe and effective.
Depression in bipolar I disorder can be hard to treat, and people often need better treatment options. This study is exploring whether this medication could offer a new way to help people manage these depressive episodes more effectively.
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You will visit the study clinic multiple times over 6 weeks. At the start, you'll take either the new medication (starting at 25 mg once daily) or a placebo pill once daily—neither you nor the study team will know which one you're receiving. After 3 weeks, your dose may be increased based on how you're responding. Throughout the study, doctors will monitor your mood and check for any side effects. After the 6-week treatment period ends, you can restart any other depression or mood-stabilizing medications you were taking before.
AI-generated summary from trial data · Jun 5, 2026 · Not medical advice
United States