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ClinicalTrials.gov public records Last synced Sep 30, 2026, 7:22 PM EDT

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Showing 1–18 of 18 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Placebo + (lithium or divalproex) 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, 7:22 PM EDT
Completed Phase 3 Interventional Results available

Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression

NCT01284517
View directory record Official record
Conditions
Bipolar Depression
Interventions
Lurasidone, Placebo
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
356 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2012
U.S. locations
22
States / cities
Costa Mesa, California • Riverside, California • San Diego, California + 16 more
Source: ClinicalTrials.gov public record
Updated Nov 26, 2013 · Synced Sep 30, 2026, 7:22 PM EDT
Completed Phase 2Phase 3 Interventional Results available

Treatment for Bipolar Depression: Acute & Prophylactic Efficacy With Citalopram

NCT00562861
View directory record Official record
Conditions
Bipolar Disorder, Bipolar Depression
Interventions
citalopram + mood stabilizer, placebo + mood stabilizer
Drug
Lead sponsor
Tufts Medical Center
Other
Eligibility
18 Years to 64 Years
Enrollment
119 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2014
U.S. locations
1
States / cities
Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Mar 24, 2017 · Synced Sep 30, 2026, 7:22 PM EDT
Completed Phase 4 Interventional Results available

Allopurinol Add-on Treatment for Refractory Mania

NCT00643123
View directory record Official record
Conditions
Bipolar Disorder, Mixed Mania, Treatment-Resistant Mania
Interventions
Allopurinol, Placebo
Drug · Other
Lead sponsor
Cedars-Sinai Medical Center
Other
Eligibility
18 Years to 70 Years
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2010
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated May 8, 2019 · Synced Sep 30, 2026, 7:22 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, 7:22 PM EDT
Completed Phase 3 Interventional Results available

Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Add-on)

NCT00868452
View directory record Official record
Conditions
Bipolar Depression
Interventions
lurasidone + (lithium or divalproex), Placebo + (lithium or divalproex)
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
348 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2012
U.S. locations
27
States / cities
Little Rock, Arkansas • Anaheim, California • Chino, California + 21 more
Source: ClinicalTrials.gov public record
Updated Apr 17, 2014 · Synced Sep 30, 2026, 7:22 PM EDT
Completed Phase 3 Interventional Results available

3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects

NCT00312494
View directory record Official record
Conditions
Bipolar Disorder
Interventions
Placebo, Ziprasidone
Drug
Lead sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
680 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2008
U.S. locations
66
States / cities
Dothan, Alabama • Scottsdale, Arizona • Little Rock, Arkansas + 51 more
Source: ClinicalTrials.gov public record
Updated Mar 29, 2021 · Synced Sep 30, 2026, 7:22 PM EDT
Completed Phase 3 Interventional Accepts healthy volunteers

Combination Therapy in Dual Diagnosis Bipolar Rapid Cycling

NCT00221975
View directory record Official record
Conditions
Bipolar Disorder
Interventions
Divalproex, Lamotrigine, Lithium
Drug
Lead sponsor
University Hospitals Cleveland Medical Center
Other
Eligibility
16 Years to 65 Years
Enrollment
98 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2002 – 2007
U.S. locations
1
States / cities
Cleveland, Ohio
Source: ClinicalTrials.gov public record
Updated Dec 3, 2014 · Synced Sep 30, 2026, 7:22 PM EDT
Completed Phase 3 Interventional

Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Alcohol Dependency in Patients With Bipolar Disorder

NCT00114686
View directory record Official record
Conditions
Bipolar I Disorder, Alcohol Dependence
Interventions
Quetiapine fumarate, lithium, divalproex
Drug
Lead sponsor
AstraZeneca
Industry
Eligibility
21 Years to 60 Years
Enrollment
350 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2007
U.S. locations
38
States / cities
Cerritos, California • San Diego, California • New Haven, Connecticut + 35 more
Source: ClinicalTrials.gov public record
Updated Jan 4, 2013 · Synced Sep 30, 2026, 7:22 PM EDT
Completed Phase 3 Interventional Results available

Adjunctive Ziprasidone in the Treatment of Bipolar I Depression

NCT00483548
View directory record Official record
Conditions
Bipolar Disorder, Depression, Bipolar
Interventions
Ziprasidone, Placebo
Drug
Lead sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Industry
Eligibility
18 Years and older
Enrollment
298 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2008
U.S. locations
60
States / cities
Chandler, Arizona • Litchfield Park, Arizona • Little Rock, Arkansas + 50 more
Source: ClinicalTrials.gov public record
Updated Mar 10, 2021 · Synced Sep 30, 2026, 7:22 PM EDT
Terminated Phase 2 Interventional Results available

Adjunctive Isradipine for the Treatment of Bipolar Depression

NCT01784666
View directory record Official record
Conditions
Bipolar Disorder
Interventions
Isradipine, Placebo
Drug
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
18 Years to 65 Years
Enrollment
2 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Apr 20, 2017 · Synced Sep 30, 2026, 7:22 PM EDT
Completed Phase 3 Interventional Results available

Treatment of Mania Symptoms With Drug Therapy

NCT00183443
View directory record Official record
Conditions
Bipolar Disorder, Schizophrenia
Interventions
Divalproex-extended release (DVP-ER), Lithium, Quetiapine
Drug
Lead sponsor
Palo Alto Veterans Institute for Research
Other
Eligibility
18 Years to 65 Years
Enrollment
75 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2010
U.S. locations
1
States / cities
Palo Alto, California
Source: ClinicalTrials.gov public record
Updated Jul 17, 2018 · Synced Sep 30, 2026, 7:22 PM EDT
Completed Phase 3 Interventional

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

NCT00107731
View directory record Official record
Conditions
Bipolar I Disorder
Interventions
quetiapine fumarate, lithium, divalproex
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
36
States / cities
Birmingham, Alabama • Beverly Hills, California • Chula Vista, California + 33 more
Source: ClinicalTrials.gov public record
Updated Mar 25, 2009 · Synced Sep 30, 2026, 7:22 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 17, 2023 · Synced Sep 30, 2026, 7:22 PM EDT
Active, not recruiting Phase 4 Interventional

Sequential Multiple Assignment Randomized Trial for Bipolar Depression

NCT06433635
View directory record Official record
Conditions
Bipolar I Disorder, Depression
Interventions
Cariprazine, Aripiprazole/Escitalopram combination, Quetiapine, Lurasidone
Drug
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
18 Years to 75 Years
Enrollment
2,726 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2030
U.S. locations
17
States / cities
Birmingham, Alabama • Bloomington, Indiana • Baltimore, Maryland + 13 more
Source: ClinicalTrials.gov public record
Updated Dec 16, 2025 · Synced Sep 30, 2026, 7:22 PM EDT
Completed Phase 3 Interventional Results available

Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex

NCT01358357
View directory record Official record
Conditions
Bipolar I Disorder
Interventions
Lurasidone, Placebo
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
18 Years and older
Enrollment
965 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2015
U.S. locations
26
States / cities
Dothan, Alabama • Glendale, California • Los Angeles, California + 23 more
Source: ClinicalTrials.gov public record
Updated Sep 7, 2016 · Synced Sep 30, 2026, 7:22 PM EDT
Completed Phase 4 Interventional Results available

A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania

NCT00261443
View directory record Official record
Conditions
Bipolar Disorder
Interventions
Lithium or Valproate with placebo (PBO), Lithium or Valproate with Aripiprazole
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years and older
Enrollment
1,270 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2009
U.S. locations
29
States / cities
Tuscaloosa, Alabama • Anaheim, California • Cerritos, California + 24 more
Source: ClinicalTrials.gov public record
Updated Apr 18, 2023 · Synced Sep 30, 2026, 7:22 PM EDT
Terminated Phase 3 Interventional Results available

Efficacy and Safety of Ramelteon Sublingual in Adult Patients With Acute Depressive Episodes Associated With Bipolar I Disorder

NCT01467700
View directory record Official record
Conditions
Acute Depressive Episode
Interventions
Ramelteon SL, Placebo
Drug
Lead sponsor
Takeda
Industry
Eligibility
18 Years to 75 Years
Enrollment
490 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2015
U.S. locations
141
States / cities
Birmingham, Alabama • Dothan, Alabama • Muscle Shoals, Alabama + 137 more
Source: ClinicalTrials.gov public record
Updated May 16, 2016 · Synced Sep 30, 2026, 7:22 PM EDT