Trial of Aripiprazole in the Treatment of CD in Adolescents

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00250705
First received: November 4, 2005
Last updated: January 14, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Conduct Disorder
Drug: Aripiprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Trial of Aripiprazole in the Treatment of CD in Adolescents

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary outcome measure will be the CGI severity and improvement scale (NIMH, 1985a). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: May 2004
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Aripiprazole
    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). Thereafter the dose will be flexible based on response and tolerance for the duration of the 6 week study.
    Other Name: Abilify
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

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00250705

Locations
United States, Iowa
The University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Bristol-Myers Squibb
Investigators
Principal Investigator: Samuel Kuperman, M.D. University of Iowa
  More Information

No publications provided

Responsible Party: Samuel Kuperman, M.D., principal investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT00250705     History of Changes
Other Study ID Numbers: 200306035, B042700
Study First Received: November 4, 2005
Last Updated: January 14, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
Aripiprazole

Additional relevant MeSH terms:
Conduct Disorder
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 11, 2014