Atypical Antipsychotics in Improvement of Quality of Life in Bipolar Disorder - Full Text View

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

This study has been completed.

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:

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

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.

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

Responsible Party:	AstraZeneca ( Joon-Woo Bahn )
Study ID Numbers:	NIS-NKR-SER-2008/1
First Received:	September 2, 2008
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00745966
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

Mental Disorders

Bipolar Disorder

Mood Disorders

Quality of Life

Psychotic Disorders

ClinicalTrials.gov processed this record on October 24, 2008