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Atypical Antipsychotics in Improvement of Quality of Life in Bipolar Disorder (POLE)
This study has been completed.
First Received: September 2, 2008   Last Updated: October 3, 2008   History of Changes
Sponsored by: AstraZeneca
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00745966
  Purpose

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
Naturalistic
Observational

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources
Study Type: Observational
Official Title: A 8-Week, Multicenter, Open-Label, Observational Study of Atypical Antipsychotics in Improvement of Quality of Life in Bipolar Disorder

Further study details as provided by AstraZeneca:

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.

Estimated Enrollment: 1000
Study Start Date: July 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00745966

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

No publications provided

Responsible Party: AstraZeneca ( Joon-Woo Bahn )
Study ID Numbers: NIS-NKR-SER-2008/1
Study First Received: September 2, 2008
Last Updated: October 3, 2008
ClinicalTrials.gov Identifier: NCT00745966     History of Changes
Health Authority: Korea: Food and Drug Administration

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

Study placed in the following topic categories:
Affective Disorders, Psychotic
Tranquilizing Agents
Mental Disorders
Bipolar Disorder
Psychotropic Drugs
 Mood Disorders
Central Nervous System Depressants
Quality of Life
Psychotic Disorders
Antipsychotic Agents

Additional relevant MeSH terms:
Affective Disorders, Psychotic
Tranquilizing Agents
Mental Disorders
Bipolar Disorder
Therapeutic Uses
Physiological Effects of Drugs
 Psychotropic Drugs
Mood Disorders
Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009



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