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

October 3, 2008 updated by: AstraZeneca

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

The purpose of this study is to reassure the clinical study data on atypical antipsychotics effect on quality of life in Korean Bipolar patients.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Choonchun-si
      • Kyunggi-do, Choonchun-si, Korea, Republic of
        • Research Site
    • Joong-gu
      • Dae-gu, Joong-gu, Korea, Republic of
        • RFesearch Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
The change from the baseline to week 8 in CGI-BP and GAF scale score.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Joon-Woo Bahn, Astrazeneca, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

September 2, 2008

First Submitted That Met QC Criteria

September 2, 2008

First Posted (Estimate)

September 3, 2008

Study Record Updates

Last Update Posted (Estimate)

October 6, 2008

Last Update Submitted That Met QC Criteria

October 3, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-NKR-SER-2008/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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