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

August 23, 2007
December 15, 2009
August 2006
April 2009   (final data collection date for primary outcome measure)
Change from baseline in Clinical Global Impression-Severity (CGI-S) scale after 52 weeks treatment. [ Time Frame: Throughout the study ]
Same as current
Complete list of historical versions of study NCT00520650 on ClinicalTrials.gov Archive Site
  • 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. ]
Same as current
Not Provided
Not Provided
 
Health Evaluation of Abilify Long-term Therapy
Health Evaluation of Abilify Long-term Therapy

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.

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

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Schizophrenia
  • Schizoaffective Disorder
Drug: Aripiprazole
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
245
April 2009
April 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00520650
31-06-P01
No
Edward C.Y. Peng, Taiwan Otsuka Pharm. Co., Ltd
Taiwan Otsuka Pharm. Co., Ltd
Not Provided
Principal Investigator: Wei-Wen Lin, MD Tri-Service General Hospital
Taiwan Otsuka Pharm. Co., Ltd
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP