Plain-English translation of NCT06372964 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 whether a medication called can help reduce depression in young people (ages 10-17) who have bipolar disorder. Right now, your teen would either receive the actual medication or a placebo (inactive pill), and the study team would carefully monitor how they respond over 6 weeks. This is a Phase 3 trial, which means researchers have already done early testing and are now gathering information from a larger group of patients to confirm the treatment works.
Depression is a serious part of bipolar disorder in young people, but there aren't many treatment options specifically tested and approved for this age group. This trial exists to see whether this medication could become a safe and effective choice for teenagers struggling with bipolar depression.
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If you enroll, you'll go through a 2-week screening period where doctors confirm you meet the study requirements. Then you'll enter the 6-week treatment phase, where you'll randomly receive either the medication or a placebo—neither you nor the study team will know which at first. You'll take the medication at home and attend clinic visits to answer questions about your mood and any side effects. After the 6 weeks ends, you'll have one final visit about a week later so the team can check how you're doing.
AI-generated summary from trial data · Jun 2, 2026 · Not medical advice
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