Health Evaluation of Abilify Long-term Therapy (HEALTH)

This study has been completed.
Sponsor:
Information provided by:
Taiwan Otsuka Pharm. Co., Ltd
ClinicalTrials.gov Identifier:
NCT00520650
First received: August 23, 2007
Last updated: December 15, 2009
Last verified: December 2009
  Purpose

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 Intervention Phase
Schizophrenia
Schizoaffective Disorder
Drug: Aripiprazole
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Health Evaluation of Abilify Long-term Therapy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change from baseline in Clinical Global Impression-Severity (CGI-S) scale after 52 weeks treatment. [ Time Frame: Throughout the study ]

Secondary Outcome Measures:
  • Change from baseline in CGI-S scale at each visit during the first 39 weeks treatment. [ Time Frame: Throughout the study ]
  • Change from baseline in total score on the Brief Psychiatric Rating Scale (BPRS) at each visit during the treatment period. [ Time Frame: Throughout the study. ]
  • Change from baseline in total score on WHOQOL-BREF questionnaire at each visit during the treatment period. [ Time Frame: Throughout the study. ]
  • Change from baseline in total score on PANSS (optional) questionnaire at each visit during the treatment period. [ Time Frame: throughout the study ]
  • Change from baseline in total score on SFS (optional) questionnaire at 12 and 52 weeks treatment. [ Time Frame: Throughout the study. ]
  • Change from Visit 2 on POM questionnaire at each visit during the 12-week switching period. [ Time Frame: Throughout the study. ]
  • CGI-I scores after 12, 26, 39, and 52 weeks of treatment. [ Time Frame: Throughout the study. ]

Enrollment: 245
Study Start Date: August 2006
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00520650

Locations
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, Taiwan
Sponsors and Collaborators
Taiwan Otsuka Pharm. Co., Ltd
Investigators
Principal Investigator: Wei-Wen Lin, MD Tri-Service General Hospital
  More Information

No publications provided

Responsible Party: Edward C.Y. Peng, Taiwan Otsuka Pharm. Co., Ltd
ClinicalTrials.gov Identifier: NCT00520650     History of Changes
Other Study ID Numbers: 31-06-P01
Study First Received: August 23, 2007
Last Updated: December 15, 2009
Health Authority: Taiwan: Institutional Review Board

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 20, 2014