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Health Evaluation of Abilify Long-term Therapy (HEALTH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00520650
First Posted: August 24, 2007
Last Update Posted: December 16, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Taiwan Otsuka Pharm. Co., Ltd
  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: Intervention Model: Single Group Assignment
Masking: None (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: August 23, 2007
First Posted: August 24, 2007
Last Update Posted: December 16, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs