NCT00745966CompletedNot Applicable
A 8-Week, Multicenter, Open-Label, Observational Study of Atypical Antipsychotics in Improvement of Quality of Life in Bipolar Disorder
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 1,000
- Locations
- 2
- Primary Endpoint
- The change from the baseline to week 8 in Short Form of the Quality of Life Enjoyment and satisfaction Questionnaire (Q-LES-Q) score
Study Overview
Brief Summary
The purpose of this study is to reassure the clinical study data on atypical antipsychotics effect on quality of life in Korean Bipolar patients.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The patient and the patient's legal representative (if any) must understand the nature of the study and must have given written consent.
- •Meet DSM-IV-TR criteria for bipolar disorder (bipolar I disorder, bipolar II disorder) at the time of baseline.
Exclusion Criteria
- •Serious or unstable, medical illness. Subjects with chronic illness may be included but must be stable and otherwise physically healthy on the basis of a physical examination, medical history.
- •Known intolerance for or lack of response to atypical antipsychotics , as judged by the investigator.
Outcomes
Primary Outcomes
The change from the baseline to week 8 in Short Form of the Quality of Life Enjoyment and satisfaction Questionnaire (Q-LES-Q) score
Secondary Outcomes
- The change from the baseline to week 8 in CGI-BP and GAF scale score.
Investigators
Study Sites (2)
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