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Risperidone Augmentation for Treatment-Resistant Aggression in ADHD

This study has been completed.
Janssen, LP
Information provided by:
Armenteros, Jorge L., M.D., P.A. Identifier:
First received: February 28, 2006
Last updated: March 15, 2006
Last verified: March 2006

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.

Condition Intervention Phase
Aggression Drug: Risperidone Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Risperidone Augmentation for Treatment-Resistant Aggression in ADHD

Resource links provided by NLM:

Further study details as provided by Armenteros, Jorge L., M.D., P.A.:

Primary Outcome Measures:
  • Children' Aggression Scale

Secondary Outcome Measures:
  • Clinical Global Impressions

Estimated Enrollment: 25
Study Start Date: January 2003
Estimated Study Completion Date: April 2005
  Show Detailed Description


Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00297739

United States, Florida
Jorge L. Armenteros, M.D., P.A.
Coral Gables, Florida, United States, 33134
Sponsors and Collaborators
Armenteros, Jorge L., M.D., P.A.
Janssen, LP
Principal Investigator: Jorge L Armenteros, MD Jorge L. Armenteros, M.D., P.A.
  More Information Identifier: NCT00297739     History of Changes
Other Study ID Numbers: RIS-ATT-401
Study First Received: February 28, 2006
Last Updated: March 15, 2006

Keywords provided by Armenteros, Jorge L., M.D., P.A.:

Additional relevant MeSH terms:
Behavioral Symptoms
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents processed this record on August 17, 2017