A Randomized Trial of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder
Phase 3
400
about 3.1 years
18–74
27 sites in AR, AZ, CA +11
About this study
This trial is testing a treatment called azetukalner versus a placebo (inactive pill) for people with bipolar depression. The goal is to see if azetukalner helps improve depressive symptoms in adults diagnosed with bipolar disorder.
Based on ClinicalTrials.gov records.
What participants do
- 1.Take Azetukalner
- 2.Take Placebo
Participation effort
Estimated from trial records. Details can vary by site.
Logistics difficulty varies by site location and availability.
Trial highlights
Treatment details
Auto-extracted from trial records to preview treatments and outcomes.
Primary: Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6.
Secondary: Change from baseline in the Clinical Global Impression of Severity (CGI-S) score at Week 6., Change from baseline in the MADRS total score at Week 1., Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score at Week 6.
Psychiatry / Mental Health