A Switch Study of BMS-337039 in Schizophrenic Out-patients
- Registration Number
- NCT00232687
- Brief Summary
The purpose of this clinical research study is to evaluate the safety and tolerability of two switching strategies from risperidone to aripiprazole over a period of 12 weeks in out-patients who are treated in a general psychiatric practice setting and who are currently experiencing efficacy and/or safety/tolerability issues while on risperidone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 450
Inclusion Criteria
- Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR2 criteria
- Out-patients who have been taking Risperidone for minimum 6 weeks who are not optimally controlled and/or experiencing safety/tolerability issues with Risperidone
- Men and women, aged 18 - 65 years
Exclusion Criteria
- Patients who are at risk for committing suicide
- Patients with a diagnosis of schizoaffective disorder, bipolar disorder, depression with psychotic symptoms, or organic brain syndromes
- Meeting DSM-IV-TR criteria for any significant Psychoactive Substance Use Disorder within the 3 months prior to Screening
- Treatment-resistant to antipsychotic medication
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A1 Aripiprazole - A2 Aripiprazole -
- Primary Outcome Measures
Name Time Method Proportion of patients who discontinue because of Adverse Events
- Secondary Outcome Measures
Name Time Method Change in Clinical Global Impression scale, Investigator Assessment Questionnaire, cognitive functioning and outcome research assessments at endpoint
Trial Locations
- Locations (1)
Local Institution
🇬🇧Haywards Health, West Sussex, United Kingdom