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Clinical Trials/NCT00520650
NCT00520650CompletedPhase 4

Health Evaluation of Abilify Long-term Therapy

Taiwan Otsuka Pharm. Co., Ltd11 sites in 1 country245 target enrollmentStarted: August 1, 2006Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
245
Locations
11
Primary Endpoint
Change from baseline in Clinical Global Impression-Severity (CGI-S) scale after 52 weeks treatment.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Detailed Description

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Male or female patients between the ages of 18 to
  • •Having a DSM-IV diagnosis of schizophrenia or schizoaffective disorder.
  • •Who are currently taking antipsychotic drugs and clinically intolerable or inadequately controlled that is based upon the clinical judgment of the investigator.

Exclusion Criteria

  • •Pregnant or breast feeding women or planning a pregnancy.
  • •Patient received electroconvulsive therapy within 4 weeks before the Screening Visit.
  • •A known allergy reaction to any antipsychotic medication (including but not limited to haloperidol, chlorpromazine, thioridazine, pimozide, risperidone, quetiapine, ziprasidone).
  • •Patient has clinically relevant organic, neurological, or cardiovascular diseases.
  • •Patient has a history of drug or alcohol abuse within the last 12 weeks.
  • •Acute psychosis, acute suicidal ideation, or any acute psychiatric condition that might require emergent intervention.
  • •Any clinical condition or significant concurrent disease judged by the investigator to complicate the evaluation of the study treatment.
  • •Having participated other investigational drug study and taken the investigation drug within one month prior to study entry.
  • •Depot neuroleptics should be discontinued at least 2 months prior to enrollment.

Outcomes

Primary Outcomes

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

Time Frame: Throughout the study

Secondary Outcomes

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

Investigators

Sponsor
Taiwan Otsuka Pharm. Co., Ltd
Sponsor Class
Industry

Study Sites (11)

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