Trials / Completed
CompletedNCT00422123
Phase 3 /Seroquel SR Acute Mania Monotherapy - US
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled, Phase III Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Mania
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 447 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Mania for 3 weeks. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Conditions
- Affective Psychosis, Bipolar
- Manic Disorder
- Manic-Depressive Psychosis
- Mania
- Manic State
- Psychoses, Manic-Depressive
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Quetiapine fumarate (Seroquel) SR |
Timeline
- Start date
- 2007-01-01
- Completion
- 2007-07-01
- First posted
- 2007-01-15
- Last updated
- 2009-03-25
Locations
51 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00422123. Inclusion in this directory is not an endorsement.