Clinical trial NCT00520650: Health Evaluation of Abilify Long-term Therapy
Official title: Health Evaluation of Abilify Long-term Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: Taiwan Otsuka Pharm. Co., Ltd
Sponsor class: INDUSTRY
First posted: 2007-08-24
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change from baseline in Clinical Global Impression-Severity (CGI-S) scale after 52 weeks treatment.
timeFrame: Throughout the study
Secondary outcomes:
measure: Change from baseline in CGI-S scale at each visit during the first 39 weeks treatment.
timeFrame: Throughout the study
measure: Change from baseline in total score on the Brief Psychiatric Rating Scale (BPRS) at each visit during the treatment period.
timeFrame: Throughout the study.
measure: Change from baseline in total score on WHOQOL-BREF questionnaire at each visit during the treatment period.
timeFrame: Throughout the study.
measure: Change from baseline in total score on PANSS (optional) questionnaire at each visit during the treatment period.
timeFrame: throughout the study
measure: Change from baseline in total score on SFS (optional) questionnaire at 12 and 52 weeks treatment.
timeFrame: Throughout the study.
measure: Change from Visit 2 on POM questionnaire at each visit during the 12-week switching period.
timeFrame: Throughout the study.
measure: CGI-I scores after 12, 26, 39, and 52 weeks of treatment.
timeFrame: Throughout the study.
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Hsinchu
country: Taiwan
facility: Cardinal Tien Hospital Hsin Chu Mercy Branch
city: Hualien
country: Taiwan
facility: Buddhist Tzu Chi General Hospital
city: Miaoli
country: Taiwan
facility: Wei Gong Memorial Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Cathay General Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Yun-Lin
country: Taiwan
facility: National Taiwan University Hospital Yun-Lin Branch
Study officials:
affiliation: Tri-Service General Hospital
name: Wei-Wen Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: