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Showing 1–24 of 25 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: Depressive Episodes, Bipolar I Depression Clear all
Completed Phase 3 Interventional

A Double-Blind Randomized Placebo Controlled Study of Quetiapine for the Treatment of Depression in Adolescents With Bipolar Disorder

NCT00232414
View directory record Official record
Conditions
Bipolar I Disorder
Interventions
Quetiapine
Drug
Lead sponsor
University of Cincinnati
Other
Eligibility
12 Years to 18 Years
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2007
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Dec 9, 2013 · Synced Jul 21, 2026, 7:29 PM EDT
Completed Phase 3 Interventional Results available

Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode in Participants With Bipolar I Disorder

NCT02670538
View directory record Official record
Conditions
Bipolar Disorder, Depression
Interventions
Cariprazine, Placebo
Drug
Lead sponsor
Forest Laboratories
Industry
Eligibility
18 Years to 65 Years
Enrollment
493 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2018
U.S. locations
42
States / cities
Birmingham, Alabama • Dothan, Alabama • Phoenix, Arizona + 37 more
Source: ClinicalTrials.gov public record
Updated Mar 11, 2019 · Synced Jul 21, 2026, 7:29 PM EDT
Terminated Phase 3 Interventional Results available

A Clinical Trial to Determine the Long-term Safety and Tolerability of an Investigational Drug in People With Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression).

NCT05227209
View directory record Official record
Conditions
Depressive Episodes, Bipolar I Depression
Interventions
SEP-4199 CR
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
64 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
25
States / cities
Huntsville, Alabama • Anaheim, California • Imperial, California + 22 more
Source: ClinicalTrials.gov public record
Updated Feb 20, 2025 · Synced Jul 21, 2026, 7:29 PM EDT
Completed Phase 3 Interventional Results available

Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally

NCT03249376
View directory record Official record
Conditions
Bipolar Depression
Interventions
Lumateperone, Placebo
Drug · Other
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
381 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
14
States / cities
Birmingham, Alabama • Sherman Oaks, California • Miami, Florida + 11 more
Source: ClinicalTrials.gov public record
Updated Jun 2, 2022 · Synced Jul 21, 2026, 7:29 PM EDT
Completed No phase listed Observational Accepts healthy volunteers

Lithium Effects on the Brain's Functional and Structural Connectome in the Treatment of Bipolar Disorder

NCT03336918
View directory record Official record
Conditions
Bipolar Disorder, Bipolar I Depression, Bipolar II Depression, Bipolar Depression, Depression, Major Depressive Episode
Interventions
Lithium
Drug
Lead sponsor
Brigham and Women's Hospital
Other
Eligibility
18 Years to 60 Years
Enrollment
81 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017 – 2025
U.S. locations
1
States / cities
Cleveland, Ohio
Source: ClinicalTrials.gov public record
Updated Jul 15, 2026 · Synced Jul 21, 2026, 7:29 PM EDT
Completed Phase 3 Interventional

A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive Episode

NCT00094432
View directory record Official record
Conditions
Bipolar I Disorder
Interventions
Aripiprazole, Placebo
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
650 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2006
U.S. locations
40
States / cities
Mesa, Arizona • La Mesa, California • La Palma, California + 37 more
Source: ClinicalTrials.gov public record
Updated Nov 10, 2013 · Synced Jul 21, 2026, 7:29 PM EDT
Completed Phase 1 Interventional

A Study of SEP-380135 in Adults With Schizophrenia or Major Depressive Episode

NCT07549581
View directory record Official record
Conditions
Schizophrenia, Major Depressive Disorder (MDD), Bipolar Disorder
Interventions
SEP-380135, Placebo
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
43 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2025
U.S. locations
1
States / cities
Los Alamitos, California
Source: ClinicalTrials.gov public record
Updated Apr 23, 2026 · Synced Jul 21, 2026, 7:29 PM EDT
Recruiting Phase 3 Interventional

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.

NCT04777357
View directory record Official record
Conditions
Depression, Bipolar I Disorder
Interventions
Cariprazine, Placebo
Drug
Lead sponsor
AbbVie
Industry
Eligibility
10 Years to 17 Years
Enrollment
380 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2027
U.S. locations
69
States / cities
Bentonville, Arkansas • Anaheim, California • Beverly Hills, California + 54 more
Source: ClinicalTrials.gov public record
Updated Jun 25, 2026 · Synced Jul 21, 2026, 7:29 PM EDT
Completed Phase 2 Interventional Results available

A Clinical Study to Test the Effectiveness of an Investigational Drug to Treat People That Have Major Depressive Episodes When They Have Bipolar 1 Depression

NCT03543410
View directory record Official record
Conditions
Depressive Episode, Bipolar 1 Depression
Interventions
SEP-4199 200 mg, SEP-4199 400 mg, Placebo
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
344 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
7
States / cities
Cerritos, California • Garden Grove, California • San Diego, California + 4 more
Source: ClinicalTrials.gov public record
Updated May 17, 2023 · Synced Jul 21, 2026, 7:29 PM EDT
Recruiting Phase 3 Interventional

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

NCT07172516
View directory record Official record
Conditions
Bipolar Disorder, Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder
Interventions
Azetukalner, Placebo
Drug
Lead sponsor
Xenon Pharmaceuticals Inc.
Industry
Eligibility
18 Years to 74 Years
Enrollment
400 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2028
U.S. locations
28
States / cities
Tucson, Arizona • Little Rock, Arkansas • Rogers, Arkansas + 23 more
Source: ClinicalTrials.gov public record
Updated Jun 2, 2026 · Synced Jul 21, 2026, 7:29 PM EDT
Completed Phase 4 Interventional Results available

A Study for Assessing Treatment of Patients Ages 10-17 With Bipolar Depression

NCT00844857
View directory record Official record
Conditions
Bipolar Depression
Interventions
Olanzapine Fluoxetine Combination (OFC), Placebo
Drug
Lead sponsor
Eli Lilly and Company
Industry
Eligibility
10 Years to 17 Years
Enrollment
291 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2012
U.S. locations
1
States / cities
San Diego, California
Source: ClinicalTrials.gov public record
Updated Feb 17, 2013 · Synced Jul 21, 2026, 7:29 PM EDT
Recruiting Phase 2 Interventional

Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With BP1MDE.

NCT07494305
View directory record Official record
Conditions
Bipolar I Disorder
Interventions
LB-102, Placebo
Drug · Other
Lead sponsor
LB Pharmaceuticals Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
320 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
26
States / cities
Bentonville, Arkansas • Little Rock, Arkansas • Bellflower, California + 23 more
Source: ClinicalTrials.gov public record
Updated May 10, 2026 · Synced Jul 21, 2026, 7:29 PM EDT
Completed Phase 3 Interventional Results available

Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression

NCT02600507
View directory record Official record
Conditions
Bipolar Depression
Interventions
Lumateperone (ITI-007), Placebo
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
529 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2020
U.S. locations
42
States / cities
Rogers, Arkansas • Cerritos, California • Costa Mesa, California + 39 more
Source: ClinicalTrials.gov public record
Updated May 16, 2023 · Synced Jul 21, 2026, 7:29 PM EDT
Recruiting Phase 2 Interventional

ALTO-100 in Bipolar Disorder With Depression (BD-D)

NCT06656416
View directory record Official record
Conditions
Bipolar Disorder I or II With a Major Depressive Episode
Interventions
ALTO-100, Placebo
Drug
Lead sponsor
Alto Neuroscience
Industry
Eligibility
18 Years to 70 Years
Enrollment
200 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
27
States / cities
Chandler, Arizona • Phoenix, Arizona • Yuma, Arizona + 22 more
Source: ClinicalTrials.gov public record
Updated Jul 15, 2025 · Synced Jul 21, 2026, 7:29 PM EDT
Terminated Phase 3 Interventional Results available

A Clinical Study of an Investigational Drug for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder.

NCT05169710
View directory record Official record
Conditions
Depressive Episodes, Bipolar I Depression
Interventions
SEP-4199 CR 200 mg, SEP-4199 CR 400 mg, Placebo
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
83 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
34
States / cities
Huntsville, Alabama • Bryant, Arkansas • Anaheim, California + 30 more
Source: ClinicalTrials.gov public record
Updated Oct 2, 2024 · Synced Jul 21, 2026, 7:29 PM EDT
Completed Phase 3 Interventional

Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depression Episode

NCT00080314
View directory record Official record
Conditions
Bipolar Disorder
Interventions
Aripiprazole, Placebo
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
400 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2006
U.S. locations
28
States / cities
Tuscaloosa, Alabama • Little Rock, Arkansas • San Diego, California + 25 more
Source: ClinicalTrials.gov public record
Updated Nov 10, 2013 · Synced Jul 21, 2026, 7:29 PM EDT
Completed Phase 4 Interventional Results available

Tranylcypromine Treatment of Bipolar Depression

NCT01430455
View directory record Official record
Conditions
Bipolar Disorder I or II
Interventions
Tranylcypromine
Drug
Lead sponsor
New York State Psychiatric Institute
Other
Eligibility
18 Years to 65 Years
Enrollment
7 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2014
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Mar 14, 2018 · Synced Jul 21, 2026, 7:29 PM EDT
Completed No phase listed Observational

Bipolar Proteomic Assay Validation Study

NCT02746367
View directory record Official record
Conditions
Major Depressive Disorder, Bipolar I and Bipolar II
Interventions
Diagnostic test (LDT)
Other
Lead sponsor
Myriad Genetic Laboratories, Inc.
Industry
Eligibility
18 Years to 70 Years
Enrollment
261 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2018
U.S. locations
5
States / cities
Iowa City, Iowa • Minneapolis, Minnesota • Mason, Ohio + 2 more
Source: ClinicalTrials.gov public record
Updated May 13, 2020 · Synced Jul 21, 2026, 7:29 PM EDT
Completed Phase 3 Interventional Results available

Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression

NCT02600494
View directory record Official record
Conditions
Bipolar Depression
Interventions
ITI-007 (Lumateperone), Placebo
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
554 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2019
U.S. locations
55
States / cities
Little Rock, Arkansas • Rogers, Arkansas • Cerritos, California + 52 more
Source: ClinicalTrials.gov public record
Updated Nov 2, 2025 · Synced Jul 21, 2026, 7:29 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 27, 2023 · Synced Jul 21, 2026, 7:29 PM EDT
Terminated Phase 2 Interventional Results available

NeoSync TMS Treatment for Bipolar I Depression

NCT02839798
View directory record Official record
Conditions
Major Depressive Episode, Bipolar Depression, Bipolar Disorder, Mood Disorders
Interventions
NEST (NeoSync EEG Synchronized TMS)
Device
Lead sponsor
Butler Hospital
Other
Eligibility
18 Years to 70 Years
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2018
U.S. locations
1
States / cities
Providence, Rhode Island
Source: ClinicalTrials.gov public record
Updated Apr 8, 2020 · Synced Jul 21, 2026, 7:29 PM EDT
Recruiting Phase 3 Interventional

Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients

NCT06372964
View directory record Official record
Conditions
Bipolar Depression
Interventions
Lumateperone, Placebo
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
10 Years to 17 Years
Enrollment
384 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2031
U.S. locations
56
States / cities
Dothan, Alabama • Little Rock, Arkansas • Anaheim, California + 38 more
Source: ClinicalTrials.gov public record
Updated Jul 6, 2026 · Synced Jul 21, 2026, 7:29 PM EDT
Completed Phase 3 Interventional Results available

Light Therapy for Bipolar Disorder. Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial

NCT00852592
View directory record Official record
Conditions
Bipolar Disorder, Major Depressive Episode
Interventions
7000lux broad-spectrum light, 50lux dim red light
Device
Lead sponsor
Northwestern University
Other
Eligibility
18 Years to 65 Years
Enrollment
46 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2015
U.S. locations
2
States / cities
Pittsburgh, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Nov 6, 2016 · Synced Jul 21, 2026, 7:29 PM EDT
Completed Phase 3 Interventional Results available

Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder

NCT04285515
View directory record Official record
Conditions
Bipolar Depression, Major Depressive Disorder
Interventions
Lumateperone, Placebos
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
488 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2022
U.S. locations
13
States / cities
Garden Grove, California • Oceanside, California • Sherman Oaks, California + 10 more
Source: ClinicalTrials.gov public record
Updated Mar 18, 2025 · Synced Jul 21, 2026, 7:29 PM EDT