drugset / Trial / NCT00250705

Trial of Aripiprazole in the Treatment of CD in Adolescents

NCT00250705

Phase 4 Completed 12 enrolled University of Iowa Bristol-Myers Squibb · collab
NaSingle-groupOpen-labelTreatment

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: \< 25 kg = 1 mg/d; 25-50 kg = 2 mg/d; 50-70 kg = 5 mg/d; \> 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.

Timeline

Start
2004-11-17
Primary completion
2009-03-23
Completion
2009-03-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Aripiprazole Other / unclassified 1 mg
Subject Aripiprazole Other / unclassified 2 mg
Subject Aripiprazole Other / unclassified 5 mg
Subject Aripiprazole Other / unclassified 10 mg
Subject Aripiprazole Other / unclassified 20 mg

Indications