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 Depression for 8 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: December 2006
Overall Status: Completed
Estimated Enrollment: 400
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 SR®) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Depression”
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 Depression for 8 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 in depression symptoms by final visit as measured by the MADRS total score
Secondary Measures
- Change from baseline to final visit on the MADRS total score MADRS item scores, CGI-BP-S, CGI-BP-C
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Provision of written informed consent
- Documented diagnosis of Bipolar 1 disorder or Bipolar 11 disorder
- Outpatient status at enrollment
Exclusion Criteria:
- Patients with >8 mood episodes during the past 12 years
- Use of prohibited medications
- 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/NCT00422214
Study ID Number: D144CC00002
ClinicalTrials.gov Identifier: NCT00422214
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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