Phase 3 Bipolar Disorder Trials
5 Phase 3 trials for Bipolar 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.
A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive...
Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States. The treatment of the...
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder...
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania...
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...
Cannabidiol for Bipolar Depression (CBD-BD)
Bipolar disorder (BD) is a lifelong condition characterized by recurrent episodes of depression and (hypo)mania. Periods of chronic and recurring depressive episodes are more...
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism...
This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism...