Atypical Antipsychotics in Improvement of Quality of Life... | NCT00745966

Studies
Atypical Antipsychotics in Improvement of Quality of Life in Bipolar Disorder

NCT00745966

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Oct 6, 2008Estimated

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Naturalistic
Observational

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Sep 2008Actual

Completion Date

Not provided

First Submitted Date

Sep 2, 2008

First Submission Date that Met QC Criteria

Sep 2, 2008

First Posted Date

Sep 3, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2008

Last Update Posted Date

Oct 6, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joon-Woo Bahn	Astrazeneca, Korea	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Kyunggi-do	Choonchun-si		South Korea
RFesearch Site