Schizophrenia and Schizoaffective Disorder Clinical Trial
Official title:
A Prospective Open-Label Study of Aripiprazole in the Management of Patients With Schizophrenia in General Psychiatric Practices
The purpose of this clinical research study is to evaluate the overall effectiveness of 8 week of aripiprazole treatment.
Status | Completed |
Enrollment | 400 |
Est. completion date | November 2007 |
Est. primary completion date | November 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka America Pharmaceutical |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Global Impression-Improvement at endpoint | |||
Secondary | Clinical Global Impression scale | |||
Secondary | Investigator's Assessment Questionnaire | |||
Secondary | Patient preference of medication at endpoint |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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