Phase 3 Bipolar Disorder Clinical Trials
12 recruitingPhase 3
What is a Phase 3 trial?
Phase 3 trials compare the new treatment against the current standard of care in large groups, often hundreds to thousands of participants. Successful Phase 3 results are typically required for regulatory approval.
Showing 1–12 of 12 trials
Recruiting
Phase 3
A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
Bipolar DisorderMania
Bristol-Myers Squibb424 enrolled103 locationsNCT07140913
Recruiting
Phase 3
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
Bipolar Disorder Type I With Mania or Mania With Mixed Features
Bristol-Myers Squibb274 enrolled74 locationsNCT06951711
Recruiting
Phase 3
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
Bipolar Disorder Type I With Mania
Bristol-Myers Squibb450 enrolled170 locationsNCT06929273
Recruiting
Phase 3
A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
Bipolar DisorderBipolar I DisorderBipolar II Disorder+1 more
Xenon Pharmaceuticals Inc.400 enrolled27 locationsNCT07172516
Recruiting
Phase 2Phase 3
Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy
Suicidal IdeationMajor Depressive DisorderBipolar Disorder+1 more
Michigan State University30 enrolled1 locationNCT06529029
Recruiting
Phase 3
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
SchizophreniaAutism Spectrum DisorderBipolar Disorder
Intra-Cellular Therapies, Inc.500 enrolled50 locationsNCT06229210
Recruiting
Phase 3
Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania
Bipolar Disorder, Manic
Intra-Cellular Therapies, Inc.350 enrolled42 locationsNCT06462586
Recruiting
Phase 3
Study of Lumateperone in the Treatment of Patients With Bipolar Mania
Bipolar Disorder, Manic
Intra-Cellular Therapies, Inc.350 enrolled35 locationsNCT06462612
Not Yet Recruiting
Phase 3
The INTENSIFY Trial: The Effect of a Six-Week Intensified Pharmacological Treatment (Third-Line Medication) for Bipolar Disorder Compared to Treatment as Usual (Second-Line Medication) in Participants Who Did Not Respond to a First-Line Medication Treatment.
Bipolar Disorder
The University of Adelaide50 enrolled1 locationACTRN12625000328471
Recruiting
Phase 3
Cannabidiol for Bipolar Depression (CBD-BD)
Bipolar Disorder
University of British Columbia360 enrolled6 locationsNCT05867849
Recruiting
Phase 3
The Kite Trial: Examining the Effectiveness of Ketamine for Adults with Bipolar Depression
Bipolar Disorder
The University of Melbourne98 enrolled4 locationsACTRN12624000789561
Recruiting
Phase 3
MELODY Trial: A 12-week randomised controlled trial of adjunctive melatonin or digital cognitive behavioural therapy for insomnia, or placebo to improve depressive symptoms in young adults with mood disorders
Bipolar Disorder Type IIDepressionSleep Disturbance
The University of Sydney660 enrolled1 locationACTRN12624000017527