Atypical Antipsychotics in Improvement of Quality of Life in Bipolar Disorder

Observational Clinical Trial

— POLE  

Official title:

A 8-Week, Multicenter, Open-Label, Observational Study of Atypical Antipsychotics in Improvement of Quality of Life in Bipolar Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00745966
• Other study ID #: NIS-NKR-SER-2008/1
• Status: Completed
• Phase: N/A
• First received: September 2, 2008
• Last updated: October 3, 2008
• Start date: July 2008

Study information

• Verified date: September 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Bipolar Disorder
• Naturalistic
• Observational

Locations

Country	Name	City	State
Korea, Republic of	RFesearch Site	Dae-gu	Joong-gu
Korea, Republic of	Research Site	Kyunggi-do	Choonchun-si

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The change from the baseline to week 8 in CGI-BP and GAF scale score.