Clinical trial NCT00250705: Trial of Aripiprazole in the Treatment of CD in Adolescents
Official title: Open Label Trial of Aripiprazole in the Treatment of CD in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Conduct Disorder
Keywords: Aripiprazole
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2005-11-08
Enrollment: 12
Sex: MALE
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open label trial
Primary purpose: TREATMENT

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 description: 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.

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

Primary outcomes:
measure: The Primary Outcome Efficacy Measure: Rating of Aggression Against People and/or Property Scale (RAAPP) (Kemph et al 1993)
timeFrame: 6 weeks
measure: Overt Aggression Scale-Modified (OAS-M)
timeFrame: 6 weeks
measure: Children's Aggression Scale-Parent Version
timeFrame: 6 weeks
Secondary outcomes:
measure: Secondary Outcome Measures Were the Clinical Global Impression-Severity (CGI-S) Scale (NIMH, 1985a).
timeFrame: 6 weeks
measure: Secondary Outcome Measures Were the Clinical Global Impression--Improvement (CGI-I) Scales (NIMH, 1985a).
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: The University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Samuel Kuperman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kuperman S, Calarge C, Kolar A, Holman T, Barnett M, Perry P. An open-label trial of aripiprazole in the treatment of aggression in male adolescents diagnosed with conduct disorder. Ann Clin Psychiatry. 2011 Nov;23(4):270-6.