Status:
COMPLETED
Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients With Bipolar Depression
Lead Sponsor:
AstraZeneca
Conditions:
Bipolar Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to evaluate the superior efficacy of quetiapine extended release(XR) mono-therapy, administered once daily compared to placebo, in the treatment of depressive sy...
Eligibility Criteria
Inclusion
- Provision of informed consent prior to any study specific procedures
- Male and female patients, aged 18 to 65 years, inclusive.
- Meets Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) criteria for bipolar disorder I or bipolar II, most recent episode depressed (296.5x and 296.89x).
- Hamilton Rating Scale for Depression (HAM-D) (17-item) total score of ≥ 20 and HAM-D item 1 (depressed mood) score ≥ 2 at enrolment and randomisation.
- Patients must be able to understand and comply with the requirements of the study,as judged by the Investigator
Exclusion
- Patients with a current Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) diagnosis other than bipolar disorder
- Patients whose Young Mania Rating Scale (YMRS) total score \>12 at enrolment and randomisation.
- Patients with \>8 mood episodes during the past 12 months at enrolment.
- Patients whose current episode of depression exceeds 12 months or is less than 4 weeks from enrolment.
- Patients with a history of non-response to an adequate treatment (6 weeks) with more than 2 classes of antidepressants during their current episode.
- Alcohol or other substance dependence or abuse as defined by Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) criteria at enrolment that is not in extended full or extended partial remission (12 months or longer), except caffeine and nicotine dependence.
- Patients who, in the Investigator's judgment, pose a current serious suicidal or homicidal risk, have a Hamilton Rating Scale for Depression (HAM-D) item 3 score ≥ 3, or have made a suicide attempt within the past 6 months.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
361 Patients enrolled
Trial Details
Trial ID
NCT01256177
Start Date
December 1 2010
End Date
November 1 2012
Last Update
April 15 2016
Active Locations (12)
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1
Research Site
Baoding, China
2
Research Site
Beijing, China
3
Research Site
Changsha, China
4
Research Site
Guangzhou, China