Health Evaluation of Abilify Long-term Therapy

Schizophrenia Clinical Trial

— HEALTH  

Official title:

Health Evaluation of Abilify Long-term Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00520650
• Other study ID #: 31-06-P01
• Status: Completed
• Phase: Phase 4
• First received: August 23, 2007
• Last updated: December 15, 2009
• Start date: August 2006
• Est. completion date: April 2009

Study information

• Verified date: December 2009
• Source: Taiwan Otsuka Pharm. Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a post-market surveillance, and the treatment to patients will be depended upon the decision based on physician's clinical judgment. The health profiles during the switching period, after 12 weeks short-term use, and after 52 weeks long-term use of aripiprazole will be recorded and evaluated.

Description:

Further study details as provided by Taiwan Otsuka Pharmaceutical Co., Ltd.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Male or female patients between the ages of 18 to 65.

2. Having a DSM-IV diagnosis of schizophrenia or schizoaffective disorder.

3. Who are currently taking antipsychotic drugs and clinically intolerable or inadequately controlled that is based upon the clinical judgment of the investigator.

Exclusion Criteria:

1. Pregnant or breast feeding women or planning a pregnancy.

2. Patient received electroconvulsive therapy within 4 weeks before the Screening Visit.

3. A known allergy reaction to any antipsychotic medication (including but not limited to haloperidol, chlorpromazine, thioridazine, pimozide, risperidone, quetiapine, ziprasidone).

4. Patient has clinically relevant organic, neurological, or cardiovascular diseases.

5. Patient has a history of drug or alcohol abuse within the last 12 weeks.

6. Acute psychosis, acute suicidal ideation, or any acute psychiatric condition that might require emergent intervention.

7. Any clinical condition or significant concurrent disease judged by the investigator to complicate the evaluation of the study treatment.

8. Having participated other investigational drug study and taken the investigation drug within one month prior to study entry.

9. Depot neuroleptics should be discontinued at least 2 months prior to enrollment.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• Aripiprazole

Locations

Country	Name	City	State
Taiwan	Changhua Christian Hospital	Changhua
Taiwan	Cardinal Tien Hospital Hsin Chu Mercy Branch	Hsinchu
Taiwan	Buddhist Tzu Chi General Hospital	Hualien
Taiwan	Wei Gong Memorial Hospital	Miaoli
Taiwan	Chung Shan Medical University Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Cathay General Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	National Taiwan University Hospital Yun-Lin Branch	Yun-Lin

Sponsors (1)

Lead Sponsor	Collaborator
Taiwan Otsuka Pharm. Co., Ltd

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Clinical Global Impression-Severity (CGI-S) scale after 52 weeks treatment.		Throughout the study
Secondary	Change from baseline in CGI-S scale at each visit during the first 39 weeks treatment.		Throughout the study
Secondary	Change from baseline in total score on the Brief Psychiatric Rating Scale (BPRS) at each visit during the treatment period.		Throughout the study.
Secondary	Change from baseline in total score on WHOQOL-BREF questionnaire at each visit during the treatment period.		Throughout the study.
Secondary	Change from baseline in total score on PANSS (optional) questionnaire at each visit during the treatment period.		throughout the study
Secondary	Change from baseline in total score on SFS (optional) questionnaire at 12 and 52 weeks treatment.		Throughout the study.
Secondary	Change from Visit 2 on POM questionnaire at each visit during the 12-week switching period.		Throughout the study.
Secondary	CGI-I scores after 12, 26, 39, and 52 weeks of treatment.		Throughout the study.