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ClinicalTrials.gov public records Last synced Sep 30, 2026, 5:23 PM EDT

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Showing 1–24 of 31 matching trials from the live ClinicalTrials.gov search.
Filters: Condition: Bipolar I Disorder, Manic or Mixed Clear all
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 23, 2026 · Synced Sep 30, 2026, 5:23 PM EDT
Completed 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
351 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 Jul 24, 2026 · Synced Sep 30, 2026, 5:23 PM EDT
Completed Phase 3 Interventional Results available

Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder

NCT04819776
View directory record Official record
Conditions
Bipolar I Disorder
Interventions
Iloperidone, Iloperidone Placebo
Drug
Lead sponsor
Vanda Pharmaceuticals
Industry
Eligibility
18 Years to 65 Years
Enrollment
417 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
20
States / cities
Little Rock, Arkansas • Rogers, Arkansas • Cerritos, California + 17 more
Source: ClinicalTrials.gov public record
Updated Apr 18, 2024 · Synced Sep 30, 2026, 5:23 PM EDT
Completed Phase 4 Interventional Results available

Study in Adolescents With Schizophrenia or Bipolar Disorder

NCT00982020
View directory record Official record
Conditions
Bipolar I Disorder, Schizophrenia
Interventions
Olanzapine, Standard behavioral weight intervention, Intense behavioral weight intervention
Drug · Behavioral
Lead sponsor
Eli Lilly and Company
Industry
Eligibility
13 Years to 17 Years
Enrollment
203 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2013
U.S. locations
4
States / cities
Lauderhill, Florida • Bloomfield Hills, Michigan • St Louis, Missouri + 1 more
Source: ClinicalTrials.gov public record
Updated Dec 17, 2014 · Synced Sep 30, 2026, 5:23 PM EDT
Active, not 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
253 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
20
States / cities
Little Rock, Arkansas • Rogers, Arkansas • Chino, California + 17 more
Source: ClinicalTrials.gov public record
Updated Aug 10, 2026 · Synced Sep 30, 2026, 5:23 PM EDT
Not listed 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 17, 2025 · Synced Sep 30, 2026, 5:23 PM 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 31, 2012 · Synced Sep 30, 2026, 5:23 PM EDT
Completed Phase 3 Interventional

Efficacy and Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder

NCT00081380
View directory record Official record
Conditions
Bipolar Disorder
Interventions
Seroquel®, quetiapine fumarate (atypical antipsychotic), lithium (mood stabilizer), divalproex (mood stabilizer)
Drug
Lead sponsor
AstraZeneca
Industry
Eligibility
18 Years and older
Enrollment
710 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2006
U.S. locations
81
States / cities
Birmingham, Alabama • Scottsdale, Arizona • Little Rock, Arkansas + 78 more
Source: ClinicalTrials.gov public record
Updated Dec 22, 2008 · Synced Sep 30, 2026, 5:23 PM EDT
Completed Phase 4 Interventional Results available

A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With A Recent Manic or Mixed Episode

NCT00277212
View directory record Official record
Conditions
Bipolar Disorder
Interventions
Lamotrigine + Aripiprazole, Lamotrigine + Placebo
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years and older
Enrollment
1,169 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2009
U.S. locations
62
States / cities
Birmingham, Alabama • Tucson, Arizona • Anaheim, California + 55 more
Source: ClinicalTrials.gov public record
Updated May 13, 2026 · Synced Sep 30, 2026, 5:23 PM EDT
Completed Phase 3 Interventional Results available

Safety and Efficacy of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)

NCT00257166
View directory record Official record
Conditions
Bipolar Disorder
Interventions
Ziprasidone oral capsules, placebo oral capsules
Drug
Lead sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Industry
Eligibility
10 Years to 17 Years
Enrollment
238 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2007
U.S. locations
50
States / cities
Scottsdale, Arizona • Orange, California • San Diego, California + 41 more
Source: ClinicalTrials.gov public record
Updated Mar 3, 2021 · Synced Sep 30, 2026, 5:23 PM 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
61
States / cities
Glendale, Arizona • Scottsdale, Arizona • Tucson, Arizona + 49 more
Source: ClinicalTrials.gov public record
Updated Sep 14, 2026 · Synced Sep 30, 2026, 5:23 PM EDT
Terminated Phase 4 Interventional

DB/Maintenance of Equetro (Carbamazepine) in Children With Acute Manic or Mixed Bipolar 1 Disorder

NCT02623504
View directory record Official record
Conditions
Bipolar Disorder
Interventions
Carbamazepine, Placebo
Drug
Lead sponsor
Validus Pharmaceuticals
Industry
Eligibility
10 Years to 17 Years
Enrollment
17 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2018
U.S. locations
4
States / cities
Orlando, Florida • Baltimore, Maryland • St Louis, Missouri + 1 more
Source: ClinicalTrials.gov public record
Updated Mar 3, 2023 · Synced Sep 30, 2026, 5:23 PM EDT
Completed Phase 3 Interventional

Evaluate the Safety of Depakote Extended Release Tablets in the Treatment of Mania Associated With Bipolar Disorder in Children and Adolescents

NCT00195767
View directory record Official record
Conditions
Bipolar I Disorder, Manic or Mixed
Interventions
divalproex sodium
Drug
Lead sponsor
Abbott
Industry
Eligibility
10 Years to 17 Years
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2004
U.S. locations
1
States / cities
North Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Mar 19, 2007 · Synced Sep 30, 2026, 5:23 PM 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 8, 2016 · Synced Sep 30, 2026, 5:23 PM EDT
Completed Phase 4 Interventional

Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder

NCT00034580
View directory record Official record
Conditions
Bipolar Disorder
Interventions
olanzapine, risperidone
Drug
Lead sponsor
Eli Lilly and Company
Industry
Eligibility
18 Years to 70 Years
Enrollment
326 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2001 – 2002
U.S. locations
21
States / cities
Berkley, California • Los Angeles, California • Orange, California + 18 more
Source: ClinicalTrials.gov public record
Updated Jul 19, 2006 · Synced Sep 30, 2026, 5:23 PM EDT
Completed Phase 3 Interventional Results available

Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer in Bipolar I Disorder (Manic or Mixed)

NCT00280566
View directory record Official record
Conditions
Bipolar Mania, Bipolar Disorder
Interventions
Placebo, Ziprasidone Oral Capsule
Drug
Lead sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Industry
Eligibility
18 Years and older
Enrollment
584 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2008
U.S. locations
73
States / cities
Birmingham, Alabama • Scottsdale, Arizona • Little Rock, Arkansas + 59 more
Source: ClinicalTrials.gov public record
Updated Mar 25, 2021 · Synced Sep 30, 2026, 5:23 PM 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 28, 2023 · Synced Sep 30, 2026, 5:23 PM 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 16, 2025 · Synced Sep 30, 2026, 5:23 PM EDT
Completed Phase 3 Interventional Results available

A Study to Evaluate the Effectiveness and Safety of Extended-Release (ER) Paliperidone Compared With Placebo in Delaying the Recurrence of Symptoms in Bipolar I Disorder

NCT00490971
View directory record Official record
Conditions
Bipolar Disorder
Interventions
Olanzapine, Paliperidone ER, Placebo
Drug
Lead sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Industry
Eligibility
18 Years to 65 Years
Enrollment
768 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2010
U.S. locations
16
States / cities
Scottsdale, Arizona • Riverside, California • San Diego, California + 13 more
Source: ClinicalTrials.gov public record
Updated Apr 15, 2015 · Synced Sep 30, 2026, 5:23 PM 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 21, 2012 · Synced Sep 30, 2026, 5:23 PM 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 Sep 24, 2026 · Synced Sep 30, 2026, 5:23 PM EDT
Completed Phase 4 Interventional

The Young Adult and Pediatric Bipolar Study

NCT00350857
View directory record Official record
Conditions
Bipolar I Disorder
Interventions
Extended-Release Carbamazepine
Drug
Lead sponsor
Validus Pharmaceuticals
Industry
Eligibility
10 Years to 17 Years
Enrollment
161 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2007
U.S. locations
26
States / cities
Altamonte Springs, Florida • Fort Lauderdale, Florida • Gainesville, Florida + 22 more
Source: ClinicalTrials.gov public record
Updated Feb 20, 2014 · Synced Sep 30, 2026, 5:23 PM 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 10, 2020 · Synced Sep 30, 2026, 5:23 PM EDT
Completed 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
354 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 Jul 24, 2026 · Synced Sep 30, 2026, 5:23 PM EDT