A Comparative, Randomized, Open-Label, Multicenter Study on the Efficacy and Safety of Switch Treatment With Aripiprazole in Schizophrenic Out-patients Who Are Experiencing Insufficient Efficacy With Risperidone and/or Safety and Tolerability Issues, While on Risperidone

Otsuka Pharmaceutical Development & Commercialization, Inc.1 site in 1 country450 target enrollmentJune 2005

ConditionsSchizophrenia

InterventionsAripiprazole

DrugsAripiprazole

Overview

Phase: Phase 4
Intervention: Aripiprazole
Conditions: Schizophrenia
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Enrollment: 450
Locations: 1
Primary Endpoint: Proportion of patients who discontinue because of Adverse Events
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2005

End Date

April 2007

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Eligibility Criteria

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