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Atypical Antipsychotics in Improvement of Quality of Life in Bipolar Disorder (POLE)

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ClinicalTrials.gov Identifier: NCT00745966
Recruitment Status : Completed
First Posted : September 3, 2008
Last Update Posted : October 6, 2008
Sponsor:
Information provided by:
AstraZeneca

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.

Condition or disease
Naturalistic Observational

Study Type : Observational
Estimated Enrollment : 1000 participants
Official Title: A 8-Week, Multicenter, Open-Label, Observational Study of Atypical Antipsychotics in Improvement of Quality of Life in Bipolar Disorder
Study Start Date : July 2008
Actual Primary Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder




Primary Outcome Measures :
  1. 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 :
  1. The change from the baseline to week 8 in CGI-BP and GAF scale score.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00745966


Locations
Korea, Republic of
Research Site
Kyunggi-do, Choonchun-si, Korea, Republic of
RFesearch Site
Dae-gu, Joong-gu, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Joon-Woo Bahn Astrazeneca, Korea

Responsible Party: Joon-Woo Bahn, AstraZeneca
ClinicalTrials.gov Identifier: NCT00745966     History of Changes
Other Study ID Numbers: NIS-NKR-SER-2008/1
First Posted: September 3, 2008    Key Record Dates
Last Update Posted: October 6, 2008
Last Verified: September 2008

Keywords provided by AstraZeneca:
Bipolar
atypical antipsychotics
quality of life
observational

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs