Status:
COMPLETED
Risperidone Augmentation for Treatment-Resistant Aggression in ADHD
Lead Sponsor:
Armenteros, Jorge L., M.D., P.A.
Collaborating Sponsors:
Janssen, LP
Conditions:
Aggression
Eligibility:
All Genders
7-12 years
Phase:
PHASE4
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 r...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Boys and girls ages 7 to 12 years, inclusive
- Medical/neurological clearance
- Meets DSM-IV diagnosis of ADHD
- Treatment with a stimulant medication during the last three weeks
- Failure to respond to stimulant medication as documented by:
- Three acts of aggression in the past week, two of which must be acts of physical aggression against other people, objects, or self
- Aggression Questionnaire (AQ) Predatory-Affective index score of 0 or below. This indicates primarily an affective or impulsive subtype of aggression
- Minimum CGI scale rating of 4 (moderately ill)
- IQ \> 75 -
Exclusion
- Major medical problems such as cardiac, renal, thyroid diseases, and seizure disorder
- History of alcohol or substance abuse within the last 4 weeks
- Previous adequate treatment with risperidone (2 mg/day for at least 4 weeks)
- Acutely suicidal or homicidal
- Unable to sign informed consent
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00297739
Start Date
January 1 2003
End Date
April 1 2005
Last Update
March 16 2006
Active Locations (1)
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1
Jorge L. Armenteros, M.D., P.A.
Coral Gables, Florida, United States, 33134