A Switch Study of BMS-337039 in Schizophrenic Out-patients

Otsuka

Status and phase

Completed

Phase 4

Conditions

Schizophrenia

Treatments

Drug: Aripiprazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT00232687

CN138-169

Details and patient eligibility

About

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.

Enrollment

450 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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