Phase 3
Completed N=325
Aripiprazole Open-Label, Safety and Tolerability Study
Source: ClinicalTrials.gov NCT00102518 ↗Enrolled (actual)
325
Serious AEs
6.2%
Results posted
Aug 2012
Primary outcomePrimary: Percentage of Subjects Experiencing SAEs — 6.2 percentage of participants
Summary
The purpose of this study is to test the long-term safety and tolerability of aripiprazole in adolescent patients with schizophrenia, and child and adolescent patients with bipolar I disorder, manic or mixed episode.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Experiencing SAEs |
6.2 | — |
| SECONDARY Change in Change in Positive and Negative Syndrome Scale (PANSS) Total Score |
-7.5 | — |
| SECONDARY Change in Young Mania Rating Scale (Y-MRS) Total Score |
-7.74 | — |
Eligibility Criteria
Inclusion Criteria
- Adolescent patients with schizophrenia, or child and adolescent patients with bipolar I disorder, manic or mixed episode
Exclusion Criteria
- Patients with a co-morbid serious, uncontrolled systemic illness
- Patients with a significant risk of committing suicide
Data sourced from ClinicalTrials.gov (NCT00102518). 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.