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CompletedNCT00520650HEALTHUpdated Dec 16, 2009

Health Evaluation of Abilify Long-term Therapy

A Phase 4 interventional study of Aripiprazole in Schizophrenia and Schizoaffective Disorder, sponsored by Taiwan Otsuka Pharm. Co., Ltd. Completed at 9 sites in Taiwan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-12-16.

Sponsored by Taiwan Otsuka Pharm. Co., Ltd · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
245
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Schizophrenia
  • Schizoaffective Disorder
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 245 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Taiwan Otsuka Pharm. Co., Ltd is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
245 participants (actual)

Interventions

  • DrugAripiprazole
06

What researchers measure

Primary outcomes

  1. Change from baseline in Clinical Global Impression-Severity (CGI-S) scale after 52 weeks treatment.

    Time frame: Throughout the study

Secondary outcomes

  1. Change from baseline in CGI-S scale at each visit during the first 39 weeks treatment.

    Time frame: Throughout the study

  2. 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.

  3. Change from baseline in total score on WHOQOL-BREF questionnaire at each visit during the treatment period.

    Time frame: Throughout the study.

  4. Change from baseline in total score on PANSS (optional) questionnaire at each visit during the treatment period.

    Time frame: throughout the study

  5. Change from baseline in total score on SFS (optional) questionnaire at 12 and 52 weeks treatment.

    Time frame: Throughout the study.

  6. Change from Visit 2 on POM questionnaire at each visit during the 12-week switching period.

    Time frame: Throughout the study.

  7. CGI-I scores after 12, 26, 39, and 52 weeks of treatment.

    Time frame: Throughout the study.

07

Study locations

9 sites
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00520650
Lead sponsor
Taiwan Otsuka Pharm. Co., Ltd
First posted
Aug 24, 2007
Start date
Aug 2006
Primary completion
Apr 2009
Completion
Apr 2009
Last update
Dec 16, 2009

Study contacts

Wei-Wen Lin, MD
principal investigator · Tri-Service General Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

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