Back to resultsAtypical Antipsychotics in Improvement of Quality of Life in Bipolar Disorder (POLE)
Primary Purpose
Naturalistic, Observational
Status
Completed
Phase
Locations
Korea, Republic of
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Naturalistic focused on measuring Bipolar, atypical antipsychotics, quality of life, observational
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.
Sites / Locations
- Research Site
- RFesearch Site
Outcomes
Primary Outcome Measures
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 Outcome Measures
The change from the baseline to week 8 in CGI-BP and GAF scale score.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00745966
Brief Title
Atypical Antipsychotics in Improvement of Quality of Life in Bipolar Disorder
Acronym
POLE
Official Title
A 8-Week, Multicenter, Open-Label, Observational Study of Atypical Antipsychotics in Improvement of Quality of Life in Bipolar Disorder
Study Type
Observational
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Naturalistic, Observational
Keywords
Bipolar, atypical antipsychotics, quality of life, observational
7. Study Design
Enrollment
1000 (Anticipated)
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
The change from the baseline to week 8 in CGI-BP and GAF scale score.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joon-Woo Bahn
Organizational Affiliation
Astrazeneca, Korea
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Kyunggi-do
State/Province
Choonchun-si
Country
Korea, Republic of
Facility Name
RFesearch Site
City
Dae-gu
State/Province
Joong-gu
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Atypical Antipsychotics in Improvement of Quality of Life in Bipolar Disorder
We'll reach out to this number within 24 hrs