Phase 3 Bipolar Clinical Trials
22 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 1–20 of 22 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 Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder
Bipolar-I Disorder With Mania or Mania With Mixed Features
Bristol-Myers Squibb274 enrolled63 locationsNCT06951698
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 3
A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder.
DepressionBipolar I Disorder
AbbVie380 enrolled80 locationsNCT04777357
Recruiting
Phase 3
Low Frequency Right Dorsolateral Pre Frontal Cortical Repetitive TMS for Bipolar Depression
Bipolar Depression Depressed Phase
Tyler Kaster80 enrolled2 locationsNCT06986460
Recruiting
Phase 3
Evaluation of the Efficacy, Safety, and Tolerability of Lacosamide in Major Depressive Episodes of Bipolar Disorder Types I and II.
Bipolar Affective Disorder
University of Sao Paulo40 enrolled1 locationNCT07412132
Recruiting
Phase 3
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
SchizophreniaBipolar I Disorder
Alkermes, Inc.220 enrolled47 locationsNCT05303064
Recruiting
Phase 3
Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure
Major Depressive DisorderBipolar DepressionSchizophrenia and Related Disorders
Dr. Inge Winter1,254 enrolled1 locationNCT05603104
Recruiting
Phase 3
The Effect of a Six Week Intensified Pharmacological Treatment for Bipolar Depression Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.
Bipolar Depression
Dr. Inge Winter418 enrolled13 locationsNCT05973786
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
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Bipolar Depression
Intra-Cellular Therapies, Inc.384 enrolled59 locationsNCT06372964
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
Brexpiprazole Treatment for Bipolar I Depression
Bipolar Depression
Douglas Mental Health University Institute58 enrolled3 locationsNCT04569448
Recruiting
Phase 3
The Kite Trial: Examining the Effectiveness of Ketamine for Adults with Bipolar Depression
Bipolar Disorder
The University of Melbourne98 enrolled4 locationsACTRN12624000789561