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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00314184
The ClinicalTrials.gov registry entry for NCT00314184 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,255 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 325-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (286% higher). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.