Phase 3 /Seroquel SR Acute Mania 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 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...
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”
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: 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 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 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/NCT00422123
Study ID Number: D144CC00004
ClinicalTrials.gov Identifier: NCT00422123
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00422123
