Aripiprazole (BMS-337039) for Outpatients With Schizophrenia Completing Aripiprazole Clinical Trials: A Non-Comparative Rollover Protocol
Overview
- Phase
- Phase 3
- Intervention
- Aripiprazole
- Conditions
- Schizophrenia
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Enrollment
- 119
- Locations
- 1
- Primary Endpoint
- Mean Clinical Global Impression Severity Score (CGI-S) From Baseline Through End of Study- - Safety Population.
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Currently receiving aripiprazole at time of screening
- •Men and women ages 18 to 70
Exclusion Criteria
- •All patients previously discontinued from an aripiprazole study for any reason
- •Active alcohol or substance abuse
- •Patients who represent a significant risk of committing suicide
- •Patients with clinically significant abnormal laboratory test results, vital signs or ECG findings
Arms & Interventions
AI
Intervention: Aripiprazole
Outcomes
Primary Outcomes
Mean Clinical Global Impression Severity Score (CGI-S) From Baseline Through End of Study- - Safety Population.
Time Frame: 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.
Secondary Outcomes
- Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuation Due to an AE - Safety Population(Baseline to Week 348)
- Mean Exposure to Aripiprazole at Days 541 to 630, Days 721 to 810 and Days 1081 to 1170 - Safety Population(Day 1 to Day 1170)
- Number of Participants With Potentially Clinically Relevant Chemistry Laboratory Abnormalities During Treatment - Safety Population(Baseline to end of study (Week 348))
- Number of Participants With Potentially Clinically Relevant Hematology Laboratory Abnormalities During Treatment - Safety Population(Baseline to end of study (Week 348))
- Number of Participants With Potentially Clinically Relevant Vital Sign Abnormality During Treatment - Safety Population(Baseline to end of study (Week 348))
- Number of Participants With Potentially Clinically Relevant ECG Abnormalities During Treatment - Safety Population(Baseline to end of study (Week 348)