Phase 3
Completed N=85
Oral Aripiprazole Open-Label Rollover Study
Source: ClinicalTrials.gov NCT01001702 ↗Enrolled (actual)
85
Serious AEs
12.9%
Results posted
Sep 2013
Primary outcomePrimary: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths — 61; 11; 7; 1 Participants
Summary
The purpose of this study is to test the long-term safety and tolerability of oral aripiprazole in adolescent patients with schizophrenia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths |
61; 11; 7; 1 | — |
| SECONDARY Change From Baseline in Clinical Global Impression Severity of Illness (CGI-S) Score |
-0.26 | — |
| SECONDARY Number of Participants With Clinical Significant Laboratory Tests |
7; 6; 5; 5; 3; 3 | — |
| SECONDARY Number of Participants With Clinically Significant Heart Rate |
0; 0; 1; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Blood Pressure |
4; 3; 5; 2; 5; 0 | — |
| SECONDARY Number of Participants With Clinically Abnormal Changes in Electrocardiograms (ECGs) Evaluations |
7; 6; 1; 1; 5; 1 | — |
| SECONDARY Number of Participants Showing Significant Weight Gain or Loss |
37; 4 | — |
| SECONDARY Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT01001702). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.