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NCT00314184 · ClinicalTrials.gov registry record · Phase 3
Quetiapine Fumarate Bipolar Maintenance Monotherapy
A Phase 3 study of Bipolar Disorder, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,255
- Enrollment target
- 20
- Study locations
NCT00314184: Completed Phase 3 study of Bipolar Disorder, sponsored by AstraZeneca.
NCT00314184 is a Phase 3 study of Bipolar Disorder that has completed, run by AstraZeneca. The registered enrollment target is 1,255 participants, above the 325-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (286% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00314184, a Phase 3 study of Bipolar Disorder, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,255 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG quetiapine fumarate
Study Locations (20)
Florida
- Research Site - Gainesville
- Research Site - Jacksonville
- Research Site - North Miami
- Research Site - Orlando
California
- Research Site - Cerritos
- Research Site - San Diego
- Research Site - Santa Ana
District of Columbia
- Research Site - Washington D.C.
Georgia
- Research Site - Atlanta
Idaho
- Research Site - Eagle
Illinois
- Research Site - Hoffman Estates
Indiana
- Research Site - Terre Haute
Louisiana
- Research Site - Shreveport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,255 participants |
| Start Date | 2005-03 |
| Est. Completion | 2007-07 |
| Phase | Phase 3 |
What the finished NCT00314184 record still lists
NCT00314184 is an interventional study that assigns participants to a tested intervention. Its 1,255 participants enrollment target places it among the larger protocols in the corpus, above the 325-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (286% higher).
The record links to 1 condition, with Bipolar Disorder appearing as the primary indexed condition, and to 1 intervention - of which quetiapine fumarate is the first listed.
NCT00314184 names 20 study sites across 15 states, led by Florida, California, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT00314184 about?
NCT00314184 is a clinical study titled "Quetiapine Fumarate Bipolar Maintenance Monotherapy". 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 Sero...
What is the current status of trial NCT00314184?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,255 participants. The study started on 2005-03. Estimated completion is 2007-07.
What conditions does trial NCT00314184 study?
This clinical trial studies the following conditions: Bipolar Disorder.
What interventions are being tested in trial NCT00314184?
The interventions under investigation include: quetiapine fumarate (DRUG).
Who is sponsoring clinical trial NCT00314184?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00314184 being conducted?
This trial has 20 study locations across California, District of Columbia, Florida, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bipolar Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00314184's enrollment target sits among peer trials
1,255 8th of 162 higher than 155 of 162 other Bipolar Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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