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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 3, 2013 · Synced Sep 22, 2026, 4:55 PM EDT
Completed Phase 4 Interventional Results available

Comparative Effectiveness Study for Bipolar Disorder

NCT01331304
View directory record Official record
Conditions
Bipolar Disorder
Interventions
Lithium, Quetiapine
Drug
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
18 Years to 68 Years
Enrollment
482 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2013
U.S. locations
11
States / cities
Birmingham, Alabama • Stanford, California • Boston, Massachusetts + 8 more
Source: ClinicalTrials.gov public record
Updated Apr 25, 2018 · Synced Sep 22, 2026, 4:55 PM EDT
Completed Phase 4 Interventional Results available

Sequential Multiple Assignment Treatment for Bipolar Disorder

NCT01588457
View directory record Official record
Conditions
Bipolar I Disorder, Bipolar II Disorder
Interventions
Lithium, Divalproex, Lamotrigine, Quetiapine
Drug
Lead sponsor
The University of Texas Health Science Center at San Antonio
Other
Eligibility
18 Years to 65 Years
Enrollment
112 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2016
U.S. locations
2
States / cities
Cleveland, Ohio • San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Aug 18, 2020 · Synced Sep 22, 2026, 4:55 PM EDT
Completed Not applicable Interventional Accepts healthy volunteers Results available

Decision-Making in Bipolar Disorder

NCT01463111
View directory record Official record
Conditions
Bipolar Disorder
Interventions
Lithium, Valproate, Lamotrigine
Drug
Lead sponsor
Emory University
Other
Eligibility
18 Years to 65 Years
Enrollment
37 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2011 – 2016
U.S. locations
1
States / cities
Atlanta, Georgia
Source: ClinicalTrials.gov public record
Updated May 30, 2017 · Synced Sep 22, 2026, 4:55 PM EDT
Completed Phase 3 Interventional

Effectiveness of Family-Focused Treatment Plus Pharmacotherapy for Bipolar Disorder in Adolescents

NCT00332098
View directory record Official record
Conditions
Bipolar Disorder
Interventions
Family-Focused Treatment Plus Pharmacotherapy, Enhanced Care Plus Pharmacotherapy
Behavioral
Lead sponsor
University of California, Los Angeles
Other
Eligibility
13 Years to 17 Years
Enrollment
145 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2012
U.S. locations
3
States / cities
Boulder, Colorado • Cincinnati, Ohio • Pittsburgh, Pennsylvania
Source: ClinicalTrials.gov public record
Updated May 19, 2014 · Synced Sep 22, 2026, 4:55 PM EDT
Completed No phase listed Observational

Pharmacogenomics of Mood Stabilizer Response in Bipolar Disorder (PGBD)

NCT01272531
View directory record Official record
Conditions
Bipolar Affective Disorder
Interventions
Mood stabilizer treatment
Drug
Lead sponsor
University of California, San Diego
Other
Eligibility
18 Years and older
Enrollment
560 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2016
U.S. locations
8
States / cities
San Diego, California • Chicago, Illinois • Indianapolis, Indiana + 5 more
Source: ClinicalTrials.gov public record
Updated Jun 8, 2020 · Synced Sep 22, 2026, 4:55 PM EDT
Completed No phase listed Observational Accepts healthy volunteers

Lithium Therapy: Understanding Mothers, Metabolism and Mood

NCT02490241
View directory record Official record
Conditions
Bipolar Disorder
Interventions
Lithium
Drug
Lead sponsor
Northwestern University
Other
Eligibility
18 Years to 55 Years · Female only
Enrollment
9 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015 – 2020
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Oct 4, 2022 · Synced Sep 22, 2026, 4:55 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 15, 2025 · Synced Sep 22, 2026, 4:55 PM EDT
Completed Phase 2 Interventional Results available

N-Acetyl Cysteine and Aspirin as an Adjunctive Treatment for Bipolar Disorder

NCT01797575
View directory record Official record
Conditions
Bipolar Disorder
Interventions
Aspirin, N-acetyl-cysteine (NAC), Sugar Pill
Drug · Dietary Supplement
Lead sponsor
The University of Texas Health Science Center, Houston
Other
Eligibility
18 Years to 65 Years
Enrollment
38 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2017
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Apr 29, 2018 · Synced Sep 22, 2026, 4:55 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 28, 2021 · Synced Sep 22, 2026, 4:55 PM EDT
Completed Phase 4 Interventional

Antidepressant Therapy for Bipolar II Major Depression

NCT00641927
View directory record Official record
Conditions
Bipolar Type II Disorder
Interventions
Venlafaxine, Lithium Carbonate
Drug
Lead sponsor
Stanley Medical Research Institute
Other
Eligibility
18 Years and older
Enrollment
90 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2002 – 2006
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Mar 23, 2008 · Synced Sep 22, 2026, 4:55 PM EDT
Completed Phase 4 Interventional Results available

Antidepressant Therapy in Treating Bipolar Type II Major Depression

NCT00602537
View directory record Official record
Conditions
Bipolar Disorder, Depression
Interventions
Venlafaxine, Lithium Carbonate
Drug
Lead sponsor
University of Pennsylvania
Other
Eligibility
18 Years and older
Enrollment
140 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2013
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Apr 24, 2017 · Synced Sep 22, 2026, 4:55 PM EDT
Completed Not applicable Interventional

Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD)

NCT00012558
View directory record Official record
Conditions
Bipolar Disorder
Interventions
lithium, valproate, bupropion, paroxetine, lamotrigine, risperidone, inositol, tranylcypromine, Cognitive Behavioral Therapy, Family-focused Therapy, Interpersonal and Social Rhythms Therapy
Drug · Behavioral
Lead sponsor
National Institute of Mental Health (NIMH)
NIH
Eligibility
15 Years and older
Enrollment
5,000 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1998 – 2005
U.S. locations
11
States / cities
Stanford, California • Denver, Colorado • Boston, Massachusetts + 8 more
Source: ClinicalTrials.gov public record
Updated May 3, 2007 · Synced Sep 22, 2026, 4:55 PM EDT
Completed Phase 4 Interventional Results available

Effectiveness of Lithium Plus Optimized Medication in Treating People With Bipolar Disorder

NCT00667745
View directory record Official record
Conditions
Bipolar Disorder
Interventions
Lithium Carbonate, Optimized Treatment (OPT)
Drug
Lead sponsor
National Institute of Mental Health (NIMH)
NIH
Eligibility
18 Years to 80 Years
Enrollment
283 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2010
U.S. locations
6
States / cities
Stanford, California • Boston, Massachusetts • Cleveland, Ohio + 3 more
Source: ClinicalTrials.gov public record
Updated Feb 12, 2018 · Synced Sep 22, 2026, 4:55 PM EDT
Completed Phase 3 Interventional

Lithium Versus Divalproex for Treating Pediatric Bipolar Disorder

NCT00221429
View directory record Official record
Conditions
Bipolar Disorder
Interventions
Lithium, sodium divalproex, Placebo
Drug · Other
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Other
Eligibility
7 Years to 18 Years
Enrollment
153 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2001 – 2015
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Feb 7, 2024 · Synced Sep 22, 2026, 4:55 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 24, 2009 · Synced Sep 22, 2026, 4:55 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 21, 2008 · Synced Sep 22, 2026, 4:55 PM 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 Sep 22, 2026, 4:55 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 23, 2017 · Synced Sep 22, 2026, 4:55 PM EDT
Completed Phase 1Phase 2 Interventional Accepts healthy volunteers Results available

The Role of Dopamine Metabolism in the Antidepressant Effects of Sleep Deprivation and Sertraline in Depressed Patients

NCT00581009
View directory record Official record
Conditions
Major Depressive Disorder, Bipolar Disorder
Interventions
chronobiological augmentation, sertraline, lithium, one night of sleep deprivation and two FDG PET scans
Other · Drug · Radiation
Lead sponsor
University of California, Irvine
Other
Eligibility
18 Years to 75 Years
Enrollment
49 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2001 – 2011
U.S. locations
2
States / cities
Irvine, California • La Jolla, California
Source: ClinicalTrials.gov public record
Updated Oct 16, 2024 · Synced Sep 22, 2026, 4:55 PM EDT