A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Azetukalner in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
Phase 3 – large-scale trial before approval
Conditions:
Depressive episodes associated with Bipolar disorder I or II (Bipolar Depression)
Sponsor: Xenon Pharmaceuticals Inc.
trial.available_in:
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Overview
Trial status: Authorised
Change from baseline in the CGI-S score at Week 6., Change from baseline in the MADRS total score at Week 1., Change from baseline in the SHAPS total score at Week 6.
Change from baseline in the MADRS total score at Week 6.
Description
Change from baseline in the CGI-S score at Week 6., Change from baseline in the MADRS total score at Week 1., Change from baseline in the SHAPS total score at Week 6.
Who can participate
Age group: 65+ years, 18-64 years
Gender: Female, Male
Target enrollment: 123 participants
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