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Showing 1–16 of 16 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: Bipolar-I Disorder With Mania or Mania With Mixed Features Clear all
Recruiting Phase 2 Interventional

Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Bipolar I Disorder

NCT07046494
View directory record Official record
Conditions
Bipolar 1 Disorder
Interventions
RAP-219, Placebo
Drug · Other
Lead sponsor
Rapport Therapeutics Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
250 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
22
States / cities
Little Rock, Arkansas • Rogers, Arkansas • Chino, California + 18 more
Source: ClinicalTrials.gov public record
Updated Jun 21, 2026 · Synced Jul 22, 2026, 5:59 AM EDT
Recruiting Phase 3 Interventional

A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder

NCT06951698
View directory record Official record
Conditions
Bipolar-I Disorder With Mania or Mania With Mixed Features
Interventions
KarXT, Placebo
Drug · Other
Lead sponsor
Bristol-Myers Squibb
Industry
Eligibility
18 Years to 65 Years
Enrollment
274 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
22
States / cities
Bentonville, Arkansas • Little Rock, Arkansas • Anaheim, California + 18 more
Source: ClinicalTrials.gov public record
Updated Jun 25, 2026 · Synced Jul 22, 2026, 5:59 AM EDT
Recruiting Phase 3 Interventional

Study of Lumateperone in the Treatment of Patients With Bipolar Mania

NCT06462612
View directory record Official record
Conditions
Bipolar Disorder, Manic
Interventions
Lumateperone, Placebo
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
350 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
22
States / cities
Bentonville, Arkansas • Little Rock, Arkansas • Anaheim, California + 15 more
Source: ClinicalTrials.gov public record
Updated Jun 30, 2025 · Synced Jul 22, 2026, 5:59 AM EDT
Recruiting Phase 3 Interventional

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

NCT07140913
View directory record Official record
Conditions
Mania, Bipolar Disorder
Interventions
Xanomeline/Trospium Chloride, Placebo
Drug
Lead sponsor
Bristol-Myers Squibb
Industry
Eligibility
18 Years to 65 Years
Enrollment
424 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
20
States / cities
Bentonville, Arkansas • Little Rock, Arkansas • Bellflower, California + 17 more
Source: ClinicalTrials.gov public record
Updated Jun 22, 2026 · Synced Jul 22, 2026, 5:59 AM EDT
Terminated Phase 3 Interventional Results available

Safety and Tolerability of Aripiprazole in Adolescents With Schizophrenia or Children and Adolescents With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features.

NCT01122927
View directory record Official record
Conditions
Adolescent Schizophrenia, Child or Adolescent Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features
Interventions
Aripiprazole
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
10 Years to 17 Years
Enrollment
524 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2014
U.S. locations
23
States / cities
Dothan, Alabama • Downey, California • Miami, Florida + 19 more
Source: ClinicalTrials.gov public record
Updated Feb 7, 2016 · Synced Jul 22, 2026, 5:59 AM EDT
Recruiting Phase 3 Interventional

Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania

NCT06462586
View directory record Official record
Conditions
Bipolar Disorder, Manic
Interventions
Lumateperone, Placebo
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
350 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
23
States / cities
Rogers, Arkansas • Bellflower, California • Culver City, California + 18 more
Source: ClinicalTrials.gov public record
Updated Jun 30, 2025 · Synced Jul 22, 2026, 5:59 AM EDT
Recruiting Phase 3 Interventional

A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)

NCT06951711
View directory record Official record
Conditions
Bipolar Disorder Type I With Mania or Mania With Mixed Features
Interventions
KarXT, Placebo
Drug · Other
Lead sponsor
Bristol-Myers Squibb
Industry
Eligibility
18 Years to 65 Years
Enrollment
274 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
28
States / cities
Little Rock, Arkansas • Rogers, Arkansas • Culver City, California + 23 more
Source: ClinicalTrials.gov public record
Updated Jul 19, 2026 · Synced Jul 22, 2026, 5:59 AM EDT
Recruiting Phase 3 Interventional

A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)

NCT06929273
View directory record Official record
Conditions
Bipolar Disorder Type I With Mania
Interventions
KarXT, Lithium, Valproate, Lamotrigine
Drug
Lead sponsor
Bristol-Myers Squibb
Industry
Eligibility
18 Years to 65 Years
Enrollment
450 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2028
U.S. locations
52
States / cities
Glendale, Arizona • Bentonville, Arkansas • Little Rock, Arkansas + 41 more
Source: ClinicalTrials.gov public record
Updated Jul 14, 2026 · Synced Jul 22, 2026, 5:59 AM EDT
Recruiting Phase 2 Interventional

An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania

NCT07288320
View directory record Official record
Conditions
Bipolar I Disorder, Mania
Interventions
NBI-1117568, Placebo
Drug
Lead sponsor
Neurocrine Biosciences
Industry
Eligibility
18 Years to 65 Years
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2028
U.S. locations
6
States / cities
Garden Grove, California • Hollywood, California • San Diego, California + 3 more
Source: ClinicalTrials.gov public record
Updated Mar 23, 2026 · Synced Jul 22, 2026, 5:59 AM EDT
Completed Phase 3 Interventional Results available

Aripiprazole Open-Label, Safety and Tolerability Study

NCT00102518
View directory record Official record
Conditions
Schizophrenia, Bipolar Disorder
Interventions
Aripiprazole
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
10 Years to 17 Years
Enrollment
325 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2007
U.S. locations
50
States / cities
Birmingham, Alabama • Little Rock, Arkansas • Costa Mesa, California + 47 more
Source: ClinicalTrials.gov public record
Updated Aug 30, 2012 · Synced Jul 22, 2026, 5:59 AM EDT
Completed Phase 2Phase 3 Interventional

BHV-7000 Acute Treatment of Bipolar Mania

NCT06419582
View directory record Official record
Conditions
Bipolar Disorder
Interventions
BHV-7000, Placebo
Drug
Lead sponsor
Biohaven Therapeutics Ltd.
Industry
Eligibility
18 Years to 75 Years
Enrollment
274 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2025
U.S. locations
32
States / cities
Bentonville, Arkansas • Little Rock, Arkansas • Rogers, Arkansas + 26 more
Source: ClinicalTrials.gov public record
Updated Dec 15, 2025 · Synced Jul 22, 2026, 5:59 AM EDT
Completed Phase 3 Interventional Results available

A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features

NCT03573297
View directory record Official record
Conditions
Bipolar I Disorder, Mania, Depression
Interventions
Cariprazine, Placebo
Drug
Lead sponsor
AbbVie
Industry
Eligibility
18 Years to 65 Years
Enrollment
901 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2022
U.S. locations
46
States / cities
Little Rock, Arkansas • Rogers, Arkansas • Anaheim, California + 39 more
Source: ClinicalTrials.gov public record
Updated Sep 27, 2023 · Synced Jul 22, 2026, 5:59 AM EDT
Completed Phase 3 Interventional Results available

Aripiprazole in Children and Adolescents With Bipolar I Disorder

NCT00110461
View directory record Official record
Conditions
Bipolar Disorder
Interventions
Aripiprazole, placebo
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
10 Years to 17 Years
Enrollment
296 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2007
U.S. locations
53
States / cities
Scottsdale, Arizona • Little Rock, Arkansas • National City, California + 50 more
Source: ClinicalTrials.gov public record
Updated May 20, 2012 · Synced Jul 22, 2026, 5:59 AM EDT
Completed Phase 3 Interventional Results available

A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes Associated With Bipolar I Disorder

NCT03259555
View directory record Official record
Conditions
Bipolar I Disorder, Manic Episode
Interventions
Brexpiprazole, Placebo
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
322 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
29
States / cities
Little Rock, Arkansas • Rogers, Arkansas • Culver City, California + 23 more
Source: ClinicalTrials.gov public record
Updated Feb 9, 2020 · Synced Jul 22, 2026, 5:59 AM EDT
Completed Phase 3 Interventional Results available

A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes, Associated With Bipolar I Disorder

NCT03257865
View directory record Official record
Conditions
Bipolar I Disorder, Manic Episode
Interventions
Brexpiprazole, Placebo
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
333 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
27
States / cities
Little Rock, Arkansas • Bellflower, California • Cerritos, California + 21 more
Source: ClinicalTrials.gov public record
Updated Feb 10, 2020 · Synced Jul 22, 2026, 5:59 AM EDT
Active, not recruiting Phase 3 Interventional

Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients

NCT06608641
View directory record Official record
Conditions
Bipolar 1 Disorder
Interventions
Endoxifen enteric-coated tablet (8 mg), Placebo Tablets
Drug
Lead sponsor
Jina Pharmaceuticals Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
490 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2025
U.S. locations
12
States / cities
Cerritos, California • Los Angeles, California • Orange, California + 8 more
Source: ClinicalTrials.gov public record
Updated Mar 16, 2025 · Synced Jul 22, 2026, 5:59 AM EDT