Plain-English translation of NCT04777357 on ClinicalTrials.gov ↗ · Source last updated ·
Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This study is testing whether , a medication already approved for treating depression in adults with bipolar I disorder, can work safely and effectively in teenagers. About 380 young people aged 10–17 will participate. Half will receive the medication, and half will receive a placebo (a dummy pill with no active ingredient) over 6 weeks to see if the treatment truly helps reduce depressive symptoms.
Bipolar disorder affects many teenagers, but doctors have fewer proven treatment options for depressive episodes in this age group compared to adults. This trial will help doctors understand whether this medication can safely treat depression in young people with bipolar I disorder.
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You would attend weekly visits at a hospital or clinic over 6 weeks, plus a 4-week safety follow-up period. During visits, doctors will check your mood through questionnaires and rating scales, do blood tests, monitor for any side effects, and track how you're responding to the treatment. You'll have a 50–50 chance of receiving either the medication or placebo, and your dose may be adjusted at week 3 based on how you're doing.
AI-generated summary from trial data · Jul 2, 2026 · Not medical advice
United States