Health Evaluation of Abilify Long-term Therapy

NCT ID: NCT00520650

Last Updated: 2009-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2009-04-30

Brief Summary

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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

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

Conditions

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Schizophrenia Schizoaffective Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Aripiprazole

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taiwan Otsuka Pharm. Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Taiwan Otsuka Pharm. Co., Ltd

Principal Investigators

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Wei-Wen Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Tri-Service General Hospital

Locations

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Changhua Christian Hospital

Changhua, , Taiwan

Site Status

National Taiwan University Hospital Yun-Lin Branch

Douliu, , Taiwan

Site Status

Cardinal Tien Hospital Hsin Chu Mercy Branch

Hsinchu, , Taiwan

Site Status

Buddhist Tzu Chi General Hospital

Hualien City, , Taiwan

Site Status

Wei Gong Memorial Hospital

Miaoli, , Taiwan

Site Status

Chung Shan Medical University Hospital

Taichung, , Taiwan

Site Status

National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status

Cathay General Hospital

Taipei, , Taiwan

Site Status

Tri-Service General Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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31-06-P01

Identifier Type: -

Identifier Source: org_study_id