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Clinical Trials/NCT00745966
NCT00745966
Completed
Not Applicable

A 8-Week, Multicenter, Open-Label, Observational Study of Atypical Antipsychotics in Improvement of Quality of Life in Bipolar Disorder

AstraZeneca2 sites in 1 country1,000 target enrollmentJuly 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Naturalistic
Sponsor
AstraZeneca
Enrollment
1000
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
Status
Completed
Last Updated
17 years ago

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.

Registry
clinicaltrials.gov
Start Date
July 2008
End Date
September 2008
Last Updated
17 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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.

Study Sites (2)

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