Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
75 participants
INTERVENTIONAL
2005-02-28
2010-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Treatment of Bipolar Mania in Older Adults
NCT00254488
Pharmacotherapy of Treatment-Resistant Mania
NCT00518947
Lithium and Divalproex for the Treatment of Comorbid Rapid Cycling Bipolar Disorder and Substance Abuse Disorder
NCT00194129
Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents
NCT00057681
Maintenance Treatment of Bipolar Depression
NCT00183469
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This study will comprise a 12-week acute phase and a 14-week continuation phase. While the acute phase is the primary component of this study, the continuation phase will provide extended data on the characteristics and course of responders to the initial treatment combinations. Results from the continuation phase will be reported elsewhere. In the acute phase, participants will be randomly assigned to receive one of three treatments: divalproex-extended release (DV-ER) and lithium, DV-ER and quetiapine, or DV-ER and placebo. Participants will receive their intervention for 12 weeks. Participants will have weekly study visits for the first 4 weeks of the acute phase; biweekly study visits will occur for the following 8 weeks. After the acute phase, participants who have not responded to their drug regimen will complete their participation in the study.
Participants whose symptoms of mania have decreased will be offered enrollment in the 14-week continuation phase, during which time participants will continue the drug regimen they began in the acute phase. Participants will have biweekly study visits in the continuation phase. During each study visit in both phases, participants will be interviewed about their mania symptoms. Mania, depression, quality of life, and overall functioning scales will assess participants at study entry, at the end of the acute phase, and at the end of the continuation phase. Participants over 50 years of age will have an electrocardiogram (EKG) at study entry to determine cardiac function.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
DVP + placebo
Participants will receive divalproex ER at a therapeutic dose, plus placebo
Divalproex-extended release (DVP-ER)
Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
DVP + Quetiapine
Participants will receive divalproex ER at a therapeutic dose, plus quetiapine up to 800 mg
Divalproex-extended release (DVP-ER)
Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
Quetiapine
Quetiapine will be dosed to efficacy, provided in 50 mg, 100 mg, 200 mg, or 300 mg pills.
DVP + Lithium
Participants will receive divalproex ER at a therapeutic dose, plus lithium at a therapeutic blood level
Divalproex-extended release (DVP-ER)
Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
Lithium
Extended release lithium will be provided in 300 mg capsules. Participants will be dosed to a therapeutic blood level of lithium from 0.8 to 1.2 mcg/L.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Divalproex-extended release (DVP-ER)
Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
Lithium
Extended release lithium will be provided in 300 mg capsules. Participants will be dosed to a therapeutic blood level of lithium from 0.8 to 1.2 mcg/L.
Quetiapine
Quetiapine will be dosed to efficacy, provided in 50 mg, 100 mg, 200 mg, or 300 mg pills.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Experiencing symptoms of mania at study entry
* Able to speak and understand English
* Willing and able to comply with all study requirements
Exclusion Criteria
* History of intolerance to DVP, DVP-ER, lithium, or quetiapine
* Disorders that would contraindicate the use of DV, DV-ER, lithium, or quetiapine
* Use of antidepressants within 1 month prior to study entry
* Use of fluoxetine within 3 months prior to study entry
* Impaired cardiac function, as evidenced by abnormal EKG in participants 50 or over
* Unstable medical illness within 2 months prior to study entry
* At risk for suicide
* Substance abuse or dependence within 1 month prior to study entry
* Pregnancy, breastfeeding, or plans to become pregnant during the study
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Mental Health (NIMH)
NIH
Palo Alto Veterans Institute for Research
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Patricia Suppes
Director, Bipolar and Depression Research Program
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Trisha Suppes, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford School of Medicine and VA Palo Alto Health Care System
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
VA Palo Alto Health Care System
Palo Alto, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Cosgrove VE, Allende S, Gwizdowski I, Grace Fischer E, Ostacher M, Suppes T. A pilot trial of quetiapine, lithium, or placebo added to divalproex sodium for hypomanic or manic episodes in ambulatory adults with bipolar I disorder. Int J Bipolar Disord. 2022 Mar 2;10(1):7. doi: 10.1186/s40345-022-00252-w.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DSIR 83-ATSO
Identifier Type: -
Identifier Source: secondary_id
SUP0001AGG/ADO
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.