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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00745966
First received: September 2, 2008
Last updated: October 3, 2008
Last verified: September 2008
  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

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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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

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

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

ClinicalTrials.gov processed this record on August 26, 2014