Aripiprazole (BMS-337039) for Outpatients With Schizophrenia Completing Aripiprazole Clinical Trials: A Non-Comparative Rollover Protocol

NCT00239356 Phase 3 COMPLETED Results posted

The purpose of this study is to provide aripiprazole to schizophrenic outpatients and Community Treated Patients who are currently receiving aripiprazole therapy on another BMS sponsored clinical trial.

Details

Lead sponsor	Otsuka Pharmaceutical Development & Commercialization, Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	119
Start date	2003-03
Completion	2012-10

Conditions

• Schizophrenia

Interventions

• Aripiprazole

Primary outcomes

• Mean Clinical Global Impression Severity Score (CGI-S) From Baseline Through End of Study- - Safety Population. — Baseline to Week 348
  Baseline is Day 1 of the study, prior to first dose. CGI-S is a questionnaire completed by the clinician which evaluates the severity of mental illness of a participant at a specific point in time. It consists of 7 categories with the lower categories indicating less illness and the higher numbered categories indicating greater severity of illness: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3= mildly ill; 4=moderately ill; 5= markedly ill; 6=severely ill; 7=among the most extremely ill.

Countries

Canada, Croatia, Czechia, France, Hungary, Netherlands, Poland, Romania, Russia, South Africa, United Kingdom