Clinical Trial: Risperidone Augmentation for Treatment-Resistant Aggression in ADHD

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

Official Title: Risperidone Augmentation for Treatment-Resistant Aggression in ADHD

Brief Summary:

Primary objectives:

  1. To assess the short-term efficacy of risperidone augmentation for treatment-resistant aggression in children with ADHD.
  2. To assess the short-term safety and tolerability of risperidone augmentation in the same group of subjects.

Detailed Summary:

Methods and Procedures:

Study Design

The study will be a double-blind placebo-controlled trial of risperidone as an augmenting agent in 40 children, 7-12 years of age, with ADHD. All subjects would have been treated first with a stimulant medication as a single agent, but continue to present impulsive aggression. The active phase of treatment will be four weeks long, during which risperidone or placebo will be added to a constant dose of stimulant medication. The study will include a four weeks continuation phase where placebo nonresponders will have the opportunity to receive risperidone on an open basis.

Subject recruitment

Special time and effort will be devoted to subject recruitment since we recognize that it is crucial to the study. Our primary recruitment sites are the Child and Adolescent Psychiatry (CAP) outpatient clinic, the psychiatry crisis unit, and the child and adolescent psychiatry inpatient unit. Clinical staff will identify and refer to the research team potential candidates for the study. Community referrals will be sought after by means of professional liaisons and academic presentations at local psychiatric facilities. Possible subjects will then be scheduled for a full evaluation after telephone screening for inclusion and exclusion criteria. Recruitment will be continuous until the total number of proposed subjects (N=40), complete the study.

Inclusion criteria

  1. Boys and girls ages 7 to 12 years, inclusive
  2. Medical/neurological clearance
  3. Meets DSM-IV diagnosis of ADHD
  4. Tr
    Sponsor: Armenteros, Jorge L., M.D., P.A.

    Current Primary Outcome: Children' Aggression Scale

    Original Primary Outcome: Same as current

    Current Secondary Outcome: Clinical Global Impressions

    Original Secondary Outcome: Same as current

    Information By: Armenteros, Jorge L., M.D., P.A.

    Dates:
    Date Received: February 28, 2006
    Date Started: January 2003
    Date Completion: April 2005
    Last Updated: March 15, 2006
    Last Verified: March 2006