Trial of Aripiprazole in the Treatment of CD in Adolescents

NCT ID: NCT00250705

Last Updated: 2017-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-17
• Study Completion Date: 2009-03-23

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.

Conditions

Conduct Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adolescent Conduct Disorder Males

All subjects were male and had a diagnosis of conduct disorder. All subjects were offered treatment with aripiprazole.

Group Type: OTHER

Aripiprazole

Intervention Type: DRUG

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. All subjects initially received either a 5 or 10 mg/d (7.0 ± 2.6 mg/d) dose of aripiprazole. Thereafter the dose was individualized based on response and tolerance. Maximum dose was 20 mg.

Interventions

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. All subjects initially received either a 5 or 10 mg/d (7.0 ± 2.6 mg/d) dose of aripiprazole. Thereafter the dose was individualized based on response and tolerance. Maximum dose was 20 mg.

Intervention Type: DRUG

Other Intervention Names

Abilify

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

University of Iowa

OTHER

Sponsor Role: lead

Responsible Party

Samuel Kuperman, M.D.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samuel Kuperman, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

The University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 22073384 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

200306035

Identifier Type: -

Identifier Source: org_study_id