Plain-English translation of NCT06462612 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This trial is testing a medication called to see if it can help people with bipolar I disorder who are experiencing a manic episode (a period of extremely high energy, racing thoughts, and risky behavior). About 350 people will take part in this study, with some receiving and others receiving a placebo (a pill with no active medicine) to see which works better.
Manic episodes in bipolar disorder can be dangerous and deeply disruptive to people's lives. Doctors are looking for new treatment options that work faster and with fewer side effects than current medications to help people manage these severe mood swings.
You likely qualify if…
You likely don't qualify if…
You would first go through a screening visit (up to one week) to confirm you qualify for the study. Then you would be randomly assigned to either take or a matching placebo for three weeks while hospitalized, with regular check-ins to monitor how you're doing. After the three-week treatment period ends, you would have a final safety visit one week later to make sure you're doing well.
AI-generated summary from trial data · Jun 2, 2026 · Not medical advice
United States