Status:
TERMINATED
A Comparison of the Effectiveness of Seroquel XR and Seroquel XR Plus Lithium in Patients With Acute Bipolar Mania: An Open-label, Randomized, Parallel Groups, Rater-blinded, 4 Week, Multicenter, Comparative,Study
Lead Sponsor:
AstraZeneca
Conditions:
Acute Bipolar Mania
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The primary objective of this study is to compare the efficacy of Seroquel XR monotherapy compared with Seroquel XR plus lithium in the treatment of acute bipolar mania by evaluation of the changes fr...
Detailed Description
A comparison of the effectiveness of Seroquel XR and Seroquel XR plus lithium in patients with acute bipolar mania: An open-label, randomized, parallel groups, rater-blinded, 4 week, multicenter, comp...
Eligibility Criteria
Inclusion
- Female and/or male inpatients or outpatients, aged over 18 years and under 65 years
- Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
- YMRS total score =20 at enrollment and randomization (Day 1) Patients had a history of at least one manic episode that required hospitalization and/or treatment with a mood stabilizer or antipsychotic.
- Female patients must have a negative urine human chorionic gonadotropin (HCG) test at enrolment and must be using a reliable method of birth control, ie, barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive
Exclusion
- Pregnancy or lactation Meeting the criteria for any other (than bipolar disorder) DSM-IV Axis I diagnosis, concomitant organic mental disorder or mental retardation
- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization/baseline
- Known intolerance or hypersensitivity to, or lack of response to previous treatment with quetiapine fumarate or lithium
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT01254721
Start Date
December 1 2010
End Date
October 1 2012
Last Update
May 8 2014
Active Locations (5)
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1
Research Site
Ansan, Gyeonggi-do, South Korea
2
Research Site
Daegu, Gyeongsangbuk-do, South Korea
3
Research Site
Jinju, Gyeongsangnam-do, South Korea
4
Research Site
Pusan, Gyeongsangnam-do, South Korea