Phase 3
N=302
Aripiprazole in Adolescents With Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00102063 ↗Enrolled (actual)
302
Serious AEs
3.6%
Results posted
Aug 2012
Primary outcome: Primary: Change in Positive and Negative Syndrome Scale (PANSS) Total Score — -26.7; -28.6; -21.2 points — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aripiprazole tablet, 10 mg (Drug); Aripiprazole tablet, 30 mg (Drug); Placebo tablet (Drug)
- Age
- Pediatric · 13+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Primary completion
- Aug 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Positive and Negative Syndrome Scale (PANSS) Total Score |
-26.7; -28.6; -21.2 | 0.05 |
| SECONDARY Change in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Score |
-7.6; -8.1; -5.6 | — |
| SECONDARY Change in Positive and Negative Syndrome Scale (PANSS) Negative Subscale Score |
-6.9; -6.6; -5.4 | — |
| SECONDARY Change in Clinical Global Impression (CGI) Severity Score |
-1.2; -1.3; -0.9 | — |
| SECONDARY Clinical Global Impression (CGI) Improvement Score |
2.7; 2.5; 3.1 | — |
| SECONDARY Change in Children's Global Assessment Scale (CGAS) Score |
14.7; 14.8; 9.8 | — |
Summary
The purpose of this trial is to test the safety and efficacy of aripiprazole in adolescent patients with schizophrenia for a period of at least 6 weeks.
Eligibility Criteria
Inclusion Criteria
- Primary diagnosis of Schizophrenia 1
Exclusion Criteria
- Patients diagnosed with schizoaffective disorder, major depressive disorder, delirium, or bipolar disorder
Data sourced from ClinicalTrials.gov (NCT00102063). 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.