Status:
COMPLETED
Adult Bipolar Mania
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Quintiles, Inc.
Conditions:
Acute Mania
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine if lithium 600-1800 mg/day is effective when added to quetiapine fumarate extended release (quetiapine XR or SEROQUEL® XR) 400-800 mg/day in treating acute ma...
Eligibility Criteria
Inclusion
- Provision of informed consent before any study procedures are performed.
- The patient must have a documented clinical diagnosis for bipolar I disorder, including recent episode manic or mixed, and being male of females age 18-65 years, inclusive.
- Patients may be outpatients or inpatients at enrollment visit, but all patients must be inpatients when randomized and remain inpatients until discharged at the discretion of the investigator.
Exclusion
- The patient can not have had up to 8 mood episodes during the past 12 months and not been continuously hospitalized for acute bipolar for up to 3 weeks immediately before participating in the study.
- The patient can not have a past diagnosis of stroke or medically documented transient ischemic attacks (TIA) or a history of seizure disorder, except for febrile convulsions.
- The patient must not have received electroconvulsive treatment (ECT) within 90 days before participating in the study and in the doctors judgement pose a current suicidal or homicidal risk.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
356 Patients enrolled
Trial Details
Trial ID
NCT00931723
Start Date
June 1 2009
End Date
November 1 2010
Last Update
April 19 2012
Active Locations (65)
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1
Research Site
Montignies-sur-Sambre, Belgium, Belgium
2
Research Site
Overpelt, Belgium, Belgium
3
Research Site
Cedex, Cedex, Belgium
4
Research Site
Dendermonde, Belgium