Trial of Aripiprazole in the Treatment of CD in Adolescents

NCT00250705 | Completed Phase 4 Results

• 1 other identifier: 200306035
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Conduct Disorder

Keywords

Aripiprazole

Outcome Measures

Primary Outcomes (3)

• The Primary Outcome Efficacy Measure: Rating of Aggression Against People and/or Property Scale (RAAPP) (Kemph et al 1993)

  Rating of Aggression Against People and/or Property Scale (RAAPP) (Kemph et al 1993) is a global rating scale of aggression completed by clinicians. Score given based on following severity scale with subject assigned 1 number: Intolerable behavior-frequently physically attacks others and destroys property (5); Severe-occasionally physically attacks people and destroys property (4); Moderately 21); and No aggressiveness reported (1). A minimum score of 1 is best and a maximum score of 5 is worst. There are no subscale scores.

  6 weeks

• Overt Aggression Scale-Modified (OAS-M)

  OAS-M divides aggressions into 4 subtypes: 1) verbal aggression, 2) property aggression, 3) self aggression (autoaggression), and 4) physical aggression. Each subtype has an initial score ranging from 0 (least aggressive) to 4 (most aggressive). The score for each subscale is further weighed (multiplied) by a constant: verbal scale's constant is 1 (max adjusted score of 4); property scale's constant is 2 (max adjusted score 8); self scale's constant is 3 (max adjusted score 12); and physical scale's constant is 4 (max adjusted score of 16). Within a given scale, "0" is the best score and maximum adjusted scale score is worst.

  6 weeks

• Children's Aggression Scale-Parent Version

  CAS-P is a 33 item scale representing 5 domains of aggression: Items in a domain were computed based on two reference points. The first was based on a 5 point frequency range with "0" being best (never) and "4" (\> 10 times being) worst. These same items were then adjusted such that more severe acts would be weighted more heavily compared to less severe aggressive behaviors. Within a domain, 0 was the best score. Worst score for the various aggression domains were: Verbal 26.16, Against Objects and Animals 11.8, Provoked 15.84, Initiated 17.84, and Use of Weapons 13.16.

  6 weeks

Secondary Outcomes (2)

• Secondary Outcome Measures Were the Clinical Global Impression-Severity (CGI-S) Scale (NIMH, 1985a).

  6 weeks

• Secondary Outcome Measures Were the Clinical Global Impression--Improvement (CGI-I) Scales (NIMH, 1985a).

  6 weeks

Study Arms (1)

Adolescent Conduct Disorder Males

OTHER

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

Drug: Aripiprazole

Interventions

Aripiprazole 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.

Also known as: Abilify

Adolescent Conduct Disorder Males

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder.

You may not qualify if:

• Clinically significant laboratory and/or ECG abnormalities
• Pre-existing health conditions that would compromise patient safety
• Mental retardation
• Previous use of aripiprazole
• Active psychosis

Sponsors & Collaborators

• University of Iowa: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

The University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

• 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.

  PMID: 22073384 RESULT

MeSH Terms

Conditions

Conduct Disorder

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

12 subjects were recruited for this study but only 10 (83%) completed at least a week of data demonstrating the primary frustrations of the investigators in this study. Conduct disorder was a difficult diagnosis to recruit patients into this study.

Results Point of Contact

• Title: An Open Label Trial of Aripiprazole in the Treatment of Conduct Disorder in Adolescents.
• Organization: The University of Iowa

Samuel-Kuperman@uiowa.edu

319-356-1482

Study Officials

• Samuel Kuperman, M.D.

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: open label trial

Study Record Dates

• First Submitted: November 4, 2005
• First Posted: November 8, 2005
• Study Start: November 17, 2004
• Primary Completion: March 23, 2009
• Study Completion: March 23, 2009
• Last Updated: July 11, 2017
• Results First Posted: July 11, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)