Clinical Trial: Trial of Aripiprazole in the Treatment of CD in Adolescents

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Open Label Trial of Aripiprazole in the Treatment of CD in Adolescents

Brief 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.

Detailed Summary: The use of atypical antipsychotics in children began in 1992 with several small case series with clozapine. Since that time, five other atypical agents, risperidone, olanzapine, quetiapine, ziprasidone and aripiprazole have been introduced into the US market. The newer atypical agents are not associated with agranulocytosis that has limited the usefulness of clozapine. Among the atypical antipsychotics, risperidone has remained the most extensively studied in children and adolescents, for a variety of problems, including Tourette's disorder, conduct disorder, schizophrenia, aggression, and pervasive development disorder. Risperidone has been shown to be an effective treatment in many of these disorders. However, weight gain, hyperprolactinemia, and extrapyramidal symptoms (EPS) are troublesome adverse effects more commonly associated with risperidone such that the drug's utility in this aged patient population is limited. We expect that the utility of aripiprazole in treating the pediatric population will not be limited by adverse effects like the other atypical antipsychotics.
Sponsor: University of Iowa

Current Primary Outcome: The primary outcome efficacy measures will be the Rating of Aggression Against People and/or Property Scale (RAAPP) (Kemph et al 1993), Overt Aggression Scale-Modified (OAS-M) (Kay et al 1988), and Children's Aggression Scale-Parent Version (CAS-P) [ Time Frame: 6 weeks ]

Original Primary Outcome: The primary outcome efficacy measures will be the Rating of Aggression Against People and/or Property Scale (RAAPP) (Kemph et al 1993), Overt Aggression Scale-Modified (OAS-M) (Kay et al 1988), and Children's Aggression Scale-Parent Version (CAS-P)

Current Secondary Outcome: The secondary outcome measure will be the CGI severity and improvement scale (NIMH, 1985a). [ Time Frame: 6 weeks ]

Original Secondary Outcome: The secondary outcome measure will be the CGI severity and improvement scale (NIMH, 1985a).

Information By: University of Iowa

Dates:
Date Received: November 4, 2005
Date Started: May 2004
Date Completion:
Last Updated: January 14, 2010
Last Verified: January 2010