Risperidone Augmentation for Treatment-Resistant Aggression in ADHD

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Armenteros, Jorge L., M.D., P.A.
• Collaborator: Janssen, LP
• Treatments: Risperidone

Criteria

Inclusion Criteria:

1. Boys and girls ages 7 to 12 years, inclusive

2. Medical/neurological clearance

3. Meets DSM-IV diagnosis of ADHD

4. Treatment with a stimulant medication during the last three weeks

5. Failure to respond to stimulant medication as documented by:

1. Three acts of aggression in the past week, two of which must be acts of physical aggression against other people, objects, or self

2. Aggression Questionnaire (AQ) Predatory-Affective index score of 0 or below. This indicates primarily an affective or impulsive subtype of aggression

3. Minimum CGI scale rating of 4 (moderately ill)

6. IQ > 75 -

Exclusion Criteria:

1. Major medical problems such as cardiac, renal, thyroid diseases, and seizure disorder

2. History of alcohol or substance abuse within the last 4 weeks

3. Previous adequate treatment with risperidone (2 mg/day for at least 4 weeks)

4. Acutely suicidal or homicidal

5. Unable to sign informed consent