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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00745966
First Posted: September 3, 2008
Last Update Posted: October 6, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (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.
  Contacts and Locations
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
  More Information

Responsible Party: Joon-Woo Bahn, AstraZeneca
ClinicalTrials.gov Identifier: NCT00745966     History of Changes
Other Study ID Numbers: NIS-NKR-SER-2008/1
First Submitted: September 2, 2008
First Posted: September 3, 2008
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