An Open- Label Rollover Study for Subjects With Schizophrenia Completing ABILIFY® (Aripiprazole) Clinical Study 31-03-241
Overview
- Phase
- Phase 3
- Intervention
- Aripiprazole
- Conditions
- Schizophrenia
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Enrollment
- 85
- Locations
- 1
- Primary Endpoint
- Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study is to test the long-term safety and tolerability of oral aripiprazole in adolescent patients with schizophrenia.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects with a confirmed Axis I Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of schizophrenia who must have completed Otsuka study 31-03-241 (NCT00102518) treatment of adolescent subjects with schizophrenia
Exclusion Criteria
- •Patients with a co-morbid serious, uncontrolled systemic illness
- •Patients with a significant risk of committing suicide
Arms & Interventions
Oral Aripiprazole
Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
Intervention: Aripiprazole
Outcomes
Primary Outcomes
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths
Time Frame: Up to 72 months
An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject. Change in clinical relevance (severity increased) was entered as a new AE in the current trial. Abnormal laboratory test findings were considered AEs if, in the opinion of the investigator, they represented an abnormal (clinically significant) change from baseline for that individual subject. An AE was considered serious if it was fatal; life-threatening; persistently or significantly disabling or incapacitating; required in-patient hospitalization or prolonged hospitalization; a congenital anomaly/birth defect; or other medically significant event that, based upon appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention. Additional information about Adverse Events can be found in the Adverse Event section.
Secondary Outcomes
- Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)(Baseline, Up to 72 months)
- Change From Baseline in Clinical Global Impression Severity of Illness (CGI-S) Score(Baseline, Last Visit (Up to 72 Months))
- Number of Participants With Clinical Significant Laboratory Tests(Baseline, Up to 72 Months)
- Number of Participants With Clinically Significant Heart Rate(Baseline, Up to 72 months)
- Number of Participants With Clinically Significant Blood Pressure(Baseline, Up to 72 months)
- Number of Participants With Clinically Abnormal Changes in Electrocardiograms (ECGs) Evaluations(Baseline, Up to 72 months)
- Number of Participants Showing Significant Weight Gain or Loss(Baseline, Up to 72 months)