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Risperidone Augmentation for Treatment-Resistant Aggression in ADHD

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00297739
First Posted: March 1, 2006
Last Update Posted: March 16, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Janssen, LP
Information provided by:
Armenteros, Jorge L., M.D., P.A.
  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
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00297739     History of Changes
Other Study ID Numbers: RIS-ATT-401
First Submitted: February 28, 2006
First Posted: March 1, 2006
Last Update Posted: March 16, 2006
Last Verified: March 2006

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
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents