NCT00745966

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 3, 2008

Completed
Last Updated

October 6, 2008

Status Verified

September 1, 2008

Enrollment Period

2 months

First QC Date

September 2, 2008

Last Update Submit

October 3, 2008

Conditions

NaturalisticObservational

Keywords

Bipolaratypical antipsychoticsquality of lifeobservational

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Kyunggi-do, Choonchun-si, South Korea

Location

RFesearch Site

Daegu, Joong-gu, South Korea

Location

Study Officials

  • Joon-Woo Bahn

    Astrazeneca, Korea

    STUDY DIRECTOR

Study Design

Study Type
observational
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 2, 2008

First Posted

September 3, 2008

Study Start

July 1, 2008

Primary Completion

September 1, 2008

Last Updated

October 6, 2008

Record last verified: 2008-09

Locations

KR(2)