Phase III/Seroquel SR Bipolar Depression Monotherapy - US
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...
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”
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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 Investigator Information
Lead Investigator: AstraZeneca Industry
Overall Clinical Trial Officials and Contacts
Catherine Datto, MD Study Director AstraZeneca
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00422214
