NCT00292409CompletedPhase 3
A Prospective Open-Label Study of Aripiprazole in the Management of Patients With Schizophrenia in General Psychiatric Practices
Otsuka Pharmaceutical Development & Commercialization, Inc.0 sites400 target enrollmentStarted: March 1, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 400
- Primary Endpoint
- Clinical Global Impression-Improvement at endpoint
Study Overview
Brief Summary
The purpose of this clinical research study is to evaluate the overall effectiveness of 8 week of aripiprazole treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •diagnosis of schizophrenia or schizoaffective disorder being treated as outpatients,no response to past antipsychotic treatment and patients who symptoms are notoptimally controlled defined as CGI- S<7
Exclusion Criteria
- •pregnant or breastfeeding,patients at risk for committing suicide,diagnosis of mood disorders, delirium, dementia and other cognitive disorders,patients treatment resistant to otherantipyschotic medications and treatment with a long acting psychotic in which the last dose was within 3 months of treatment phase
Outcomes
Primary Outcomes
Clinical Global Impression-Improvement at endpoint
Secondary Outcomes
- Investigator's Assessment Questionnaire
- Patient preference of medication at endpoint
- Clinical Global Impression scale
Investigators
Similar Trials
Completed
Phase 3
A Study of Aripiprazole in the Management of Patients With Schizophrenia in the General Psychiatric PracticesSchizophreniaNCT00237939Otsuka Pharmaceutical Development & Commercialization, Inc.1,200
Completed
Phase 4
Aripiprazole in Patients With Psychosis Associated With Parkinson's DiseasePsychosesParkinson's DiseaseNCT00095810Otsuka Pharmaceutical Development & Commercialization, Inc.50
Completed
Phase 2
An Open-Label Trial of Aripiprazole in Autism Spectrum DisordersPervasive Developmental DisorderAsperger's DisorderAutismNCT00308074Cambridge Health Alliance14
Completed
Phase 3
A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With SchizophreniaSchizophreniaNCT01942148Otsuka Pharmaceutical Co., Ltd.68
Completed
Phase 4
Trial of Aripiprazole in the Treatment of CD in AdolescentsConduct DisorderNCT00250705University of Iowa12