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Risperidone Augmentation for Treatment-Resistant Aggression in ADHD

This study has been completed.
Sponsor:
Collaborator:
Janssen, LP
Information provided by:
Armenteros, Jorge L., M.D., P.A.
ClinicalTrials.gov Identifier:
NCT00297739
First received: February 28, 2006
Last updated: March 15, 2006
Last verified: March 2006
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Risperidone Augmentation for Treatment-Resistant Aggression in ADHD

Resource links provided by NLM:

Drug Information available for: Risperidone
U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00297739

Locations
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
Investigators
Principal Investigator: Jorge L Armenteros, MD Jorge L. Armenteros, M.D., P.A.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00297739     History of Changes
Other Study ID Numbers: RIS-ATT-401
Study First Received: February 28, 2006
Last Updated: March 15, 2006
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Aggression
Behavioral Symptoms
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
 Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 19, 2013