Quetiapine Fumarate Bipolar Maintenance Monotherapy
Public ClinicalTrials.gov record NCT00314184. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of Quetiapine Fumarate and Lithium as Monotherapy for up to 104 Weeks Maintenance Treatment of Bipolar I Disorder in Adult Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a multicenter, randomized, parallel-group, double-blind, placebo-controlled study to evaluate the efficacy and safety of quetiapine and lithium (comparator in the study) for up to 104 weeks of maintenance treatment in adult patients with Bipolar I Disorder. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Study identification
- NCT ID
- NCT00314184
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,255 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2005
- Primary completion
- Not listed
- Completion
- Jun 30, 2007
- Last update posted
- Dec 21, 2008
2005 – 2007
United States locations
- U.S. sites
- 30
- U.S. states
- 21
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Cerritos | California | — | — |
| Research Site | San Diego | California | — | — |
| Research Site | Santa Ana | California | — | — |
| Research Site | Washington D.C. | District of Columbia | — | — |
| Research Site | Gainesville | Florida | — | — |
| Research Site | Jacksonville | Florida | — | — |
| Research Site | North Miami | Florida | — | — |
| Research Site | Orlando | Florida | — | — |
| Research Site | Atlanta | Georgia | — | — |
| Research Site | Eagle | Idaho | — | — |
| Research Site | Hoffman Estates | Illinois | — | — |
| Research Site | Terre Haute | Indiana | — | — |
| Research Site | Shreveport | Louisiana | — | — |
| Research Site | Flowood | Mississippi | — | — |
| Research Site | Saint Charles | Missouri | — | — |
| Research Site | Las Vegas | Nevada | — | — |
| Research Site | Clementon | New Jersey | — | — |
| Research Site | Rochester | New York | — | — |
| Research Site | Raleigh | North Carolina | — | — |
| Research Site | Fargo | North Dakota | — | — |
| Research Site | Portland | Oregon | — | — |
| Research Site | Salem | Oregon | — | — |
| Research Site | Philadelphia | Pennsylvania | — | — |
| Research Site | Memphis | Tennessee | — | — |
| Research Site | Austin | Texas | — | — |
| Research Site | Lake Jackson | Texas | — | — |
| Research Site | Richmond | Virginia | — | — |
| Research Site | Bellevue | Washington | — | — |
| Research Site | Kirkland | Washington | — | — |
| Research Site | Seattle | Washington | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 65 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00314184, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 21, 2008 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00314184 live on ClinicalTrials.gov.