Risperidone Augmentation for Treatment-Resistant Aggression in ADHD

Completed · Phase 4

Conditions studied: Aggression

In brief

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.

Key facts

Study ID

NCT00297739

Run by

Armenteros, Jorge L., M.D., P.A.

People needed

25

Starts

2003-01-01

Expected to finish

2005-04-01

Last updated by the study team

2006-03-16

Who can join

Age: 7 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 -

You may not qualify if…

• 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

Where it is running

• Jorge L. Armenteros, M.D., P.A. — Coral Gables, Florida, United States

Full record on ClinicalTrials.gov

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