Health Evaluation of Abilify Long-term Therapy (HEALTH)

December 15, 2009 updated by: Taiwan Otsuka Pharm. Co., Ltd
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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

245

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in CGI-S scale at each visit during the first 39 weeks treatment.
Time Frame: Throughout the study
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.
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.
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
throughout the study
Change from baseline in total score on SFS (optional) questionnaire at 12 and 52 weeks treatment.
Time Frame: Throughout the study.
Throughout the study.
Change from Visit 2 on POM questionnaire at each visit during the 12-week switching period.
Time Frame: Throughout the study.
Throughout the study.
CGI-I scores after 12, 26, 39, and 52 weeks of treatment.
Time Frame: Throughout the study.
Throughout the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Wei-Wen Lin, MD, Tri-Service General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

August 23, 2007

First Submitted That Met QC Criteria

August 23, 2007

First Posted (Estimate)

August 24, 2007

Study Record Updates

Last Update Posted (Estimate)

December 16, 2009

Last Update Submitted That Met QC Criteria

December 15, 2009

Last Verified

December 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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