Phase 4
N=12
Trial of Aripiprazole in the Treatment of CD in Adolescents
Conduct Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00250705 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: The Primary Outcome Efficacy Measure: Rating of Aggression Against People and/or Property Scale (RAAPP) (Kemph et al 1993) — 1.7 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Aripiprazole (Drug)
- Age
- Pediatric · 13+ yrs
- Sex
- Male
- Sponsor
- University of Iowa
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Outcome Efficacy Measure: Rating of Aggression Against People and/or Property Scale (RAAPP) (Kemph et al 1993) |
1.7 | — |
| PRIMARY Overt Aggression Scale-Modified (OAS-M) |
1.0; 0.6; 0.6; 1.6 | — |
| PRIMARY Children's Aggression Scale-Parent Version |
2.7; 0.4; 1.6; 0.6; 0.1 | — |
| SECONDARY Secondary Outcome Measures Were the Clinical Global Impression-Severity (CGI-S) Scale (NIMH, 1985a). |
3.0 | — |
| SECONDARY Secondary Outcome Measures Were the Clinical Global Impression--Improvement (CGI-I) Scales (NIMH, 1985a). |
2.1 | — |
Summary
The proposed study will be a 6-week open label study evaluating aripiprazole in the treatment of 12 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder. The initial dose depending on the weight of the patient will be as follows: 70 kg = 10 mg/d (Data on File, 2003, Bristol-Myers Squibb). For the first two weeks of the study, the dose will be flexible based on response and tolerance and thereafter will remain fixed.
Eligibility Criteria
Inclusion Criteria
- Male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder.
Exclusion Criteria
- Clinically significant laboratory and/or ECG abnormalities
- Pre-existing health conditions that would compromise patient safety
- Mental retardation
- Previous use of aripiprazole
- Active psychosis
Data sourced from ClinicalTrials.gov (NCT00250705). 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.