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...
Date First Received: January 12, 2007
Last Updated: March 24, 2009
Verified by: AstraZeneca, March 2009
Clinical Trial Phase: Phase 3 | Start Date: January 2007
Overall Status: Completed
Estimated Enrollment: 447
Brief Summary
Official Title: “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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Quetiapine fumarate (Seroquel) SR
Outcome Measures for this Clinical Trial
Primary Measures
- Change from baseline to final visit in the YMRS total score
Secondary Measures
- Change from baseline to each visit in YMRS score and changes of YMRS subscores and changes in MADRS.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Provision of written informed consent
- Documented diagnosis of Bipolar Disorder, with most recent episode being manic or mixed
- Inpatient hospital admission for the first 4 days of study treatment
Exclusion Criteria:
- >8 mood episodes within the last 12 months
- Use of prohibited medication
- Substance or alcohol abuse or dependence
- Current suicide risk or suicide attempt within last 6 months.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: AstraZeneca
Overall Clinical Trial Officials and Contacts
Catherine Datto, MD Study Director AstraZeneca
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00422123
Study ID Number: D144CC00004
ClinicalTrials.gov Identifier: NCT00422123
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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