Efficacy & Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
Public ClinicalTrials.gov record NCT00107731. 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
A Multicenter, Randomized, Parallel-Group, Double-Blind, Phase 3 Comparison of the Efficacy & Safety of Quetiapine Fumarate to Placebo When Used as Adjunct to Mood Stabilizers (Lithium or Valproate) in the Maintenance Treatment of Bipolar I Disorder in Adult Patients (Abbreviated)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment Phase and the Randomized treatment Phase. 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
- NCT00107731
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 710 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
- Apr 2004 (Type not available)
- Primary completion
- Not listed
- Completion
- Oct 2006 (Actual)
- Last update posted
- Mar 25, 2009
2004 – 2006
United States locations
- U.S. sites
- 36
- U.S. states
- 18
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Birmingham | Alabama | — | — |
| Research Site | Beverly Hills | California | — | — |
| Research Site | Chula Vista | California | — | — |
| Research Site | Redlands | California | — | — |
| Research Site | San Francisco | California | — | — |
| Research Site | Santa Ana | California | — | — |
| Research Site | Gainesville | Florida | — | — |
| Research Site | Jacksonville | Florida | — | — |
| Research Site | Miami | Florida | — | — |
| Research Site | Sarasota | Florida | — | — |
| Research Site | Tampa | Florida | — | — |
| Research Site | Winter Park | Florida | — | — |
| Research Site | Granite City | Illinois | — | — |
| Research Site | Libertyville | Illinois | — | — |
| Research Site | Schaumburg | Illinois | — | — |
| Research Site | Wichita | Kansas | — | — |
| Research Site | Metairie | Louisiana | — | — |
| Research Site | Glen Burnie | Maryland | — | — |
| Research Site | Kalamazoo | Michigan | — | — |
| Research Site | Saint Charles | Missouri | — | — |
| Research Site | St Louis | Missouri | — | — |
| Research Site | Brooklyn | New York | — | — |
| Research Site | Olean | New York | — | — |
| Research Site | Rochester | New York | — | — |
| Research Site | Morganton | North Carolina | — | — |
| Research Site | Raleigh | North Carolina | — | — |
| Research Site | Oklahoma City | Oklahoma | — | — |
| Research Site | Portland | Oregon | — | — |
| Research Site | Havertown | Pennsylvania | — | — |
| Research Site | Media | Pennsylvania | — | — |
| Research Site | Philadelphia | Pennsylvania | — | — |
| Research Site | Conroe | Texas | — | — |
| Research Site | Houston | Texas | — | — |
| Research Site | Richmond | Virginia | — | — |
| Research Site | Seattle | Washington | — | — |
| Research Site | Milwaukee | Wisconsin | — | — |
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 130 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00107731, 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 Mar 25, 2009 · Synced Oct 23, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00107731 live on ClinicalTrials.gov.