HEALTH: Health Evaluation of Abilify Long-term Therapy
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Detailed Description
Further study details as provided by Taiwan Otsuka Pharmaceutical Co., Ltd.
Study Design
Outcome Measures
Primary Outcome Measures
- Change from baseline in Clinical Global Impression-Severity (CGI-S) scale after 52 weeks treatment. [Throughout the study]
Secondary Outcome Measures
- Change from baseline in CGI-S scale at each visit during the first 39 weeks treatment. [Throughout the study]
- Change from baseline in total score on the Brief Psychiatric Rating Scale (BPRS) at each visit during the treatment period. [Throughout the study.]
- Change from baseline in total score on WHOQOL-BREF questionnaire at each visit during the treatment period. [Throughout the study.]
- Change from baseline in total score on PANSS (optional) questionnaire at each visit during the treatment period. [throughout the study]
- Change from baseline in total score on SFS (optional) questionnaire at 12 and 52 weeks treatment. [Throughout the study.]
- Change from Visit 2 on POM questionnaire at each visit during the 12-week switching period. [Throughout the study.]
- CGI-I scores after 12, 26, 39, and 52 weeks of treatment. [Throughout the study.]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female patients between the ages of 18 to 65.
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Having a DSM-IV diagnosis of schizophrenia or schizoaffective disorder.
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Who are currently taking antipsychotic drugs and clinically intolerable or inadequately controlled that is based upon the clinical judgment of the investigator.
Exclusion Criteria:
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Pregnant or breast feeding women or planning a pregnancy.
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Patient received electroconvulsive therapy within 4 weeks before the Screening Visit.
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A known allergy reaction to any antipsychotic medication (including but not limited to haloperidol, chlorpromazine, thioridazine, pimozide, risperidone, quetiapine, ziprasidone).
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Patient has clinically relevant organic, neurological, or cardiovascular diseases.
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Patient has a history of drug or alcohol abuse within the last 12 weeks.
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Acute psychosis, acute suicidal ideation, or any acute psychiatric condition that might require emergent intervention.
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Any clinical condition or significant concurrent disease judged by the investigator to complicate the evaluation of the study treatment.
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Having participated other investigational drug study and taken the investigation drug within one month prior to study entry.
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Depot neuroleptics should be discontinued at least 2 months prior to enrollment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Changhua Christian Hospital | Changhua | Taiwan | ||
| 2 | Cardinal Tien Hospital Hsin Chu Mercy Branch | Hsinchu | Taiwan | ||
| 3 | Buddhist Tzu Chi General Hospital | Hualien | Taiwan | ||
| 4 | Wei Gong Memorial Hospital | Miaoli | Taiwan | ||
| 5 | Chung Shan Medical University Hospital | Taichung | Taiwan | ||
| 6 | National Cheng Kung University Hospital | Tainan | Taiwan | ||
| 7 | Cathay General Hospital | Taipei | Taiwan | ||
| 8 | Tri-Service General Hospital | Taipei | Taiwan | ||
| 9 | National Taiwan University Hospital Yun-Lin Branch | Yun-Lin | Taiwan |
Sponsors and Collaborators
- Taiwan Otsuka Pharm. Co., Ltd
Investigators
- Principal Investigator: Wei-Wen Lin, MD, Tri-Service General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 31-06-P01