Phase 3 Bipolar I Disorder Trials
2 Phase 3 trials for Bipolar I Disorder. Phase 3 trials are the final stage of testing before a treatment can be submitted for FDA approval.
What is a Phase 3 trial?
Phase 3 clinical trials study a treatment in large groups (hundreds to thousands of people) to confirm its effectiveness, monitor side effects, and compare it to standard treatments. These trials are the last major step before the FDA considers approving a new treatment.
RECRUITINGPhase 3NCT07172516
A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder...
X-CEED is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of azetukalner in adult participants diagnosed with...
Sponsor: Xenon Pharmaceuticals Inc.Enrolling: 40020 locations
RECRUITINGPhase 3NCT05303064
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar...
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
Sponsor: Alkermes, Inc.Enrolling: 22020 locations