Atypical Antipsychotics in Improvement of Quality of Life in Bipolar Disorder

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00745966

Acronym

POLE

Enrollment

1000

Registered

2008-09-03

Start date

2008-07-31

Completion date

Unknown

Last updated

2008-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Naturalistic, Observational

Keywords

Bipolar, atypical antipsychotics, quality of life, observational

Brief 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.

Interventions

None listed

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

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

Countries

South Korea

Outcome results