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ClinicalTrials.gov public records Last synced May 22, 2026, 1:12 AM EDT

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Showing 1–6 of 6 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: Bipolar Disorder I or II With a Major Depressive Episode Clear all
Recruiting Phase 3 Interventional
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 – 2027
U.S. locations
52
States / cities
Dothan, Alabama • Little Rock, Arkansas • Anaheim, California + 38 more
Source: ClinicalTrials.gov public record
Updated Jul 7, 2025 · Synced May 22, 2026, 1:12 AM EDT
Completed Phase 1 Interventional
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 May 22, 2026, 1:12 AM EDT
Recruiting Phase 2 Interventional
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 May 22, 2026, 1:12 AM EDT
Completed Phase 3 Interventional Results available
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 May 22, 2026, 1:12 AM EDT
Completed Phase 3 Interventional Results available
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 May 22, 2026, 1:12 AM EDT
Completed Phase 3 Interventional Results available
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 May 22, 2026, 1:12 AM EDT