Clinical Trial: Effects of Atypical Antipsychotics on Brain Function in Children and Teens With Conduct Disorders

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

Official Title: The Investigation of the Impact of Atypical Antipsychotics on Brain Functioning in Youths With Conduct Disorder

Brief Summary:

Background:

- Some children and teenagers have conditions known as conduct disorders. They often have long-term chronic behavior problems, such as defiant behavior or violence. Conduct disorders are often treated with antipsychotic medication. Researchers want to study two types of newer antipsychotics (aripiprizole and risperidone) for children and adolescents with conduct disorders. They will look at how these drugs affect brain activity. To do so, they will give brain activity tests using magnetic resonance imaging (MRI). The tests will compare the results from healthy volunteer children and teens to those of others with behavior problems.

Objectives:

- To see how atypical antipsychotics affect brain activity of children and teenagers with conduct disorders.

Eligibility:

• Children and teenagers between 10 and 18 years of age who have a conduct disorder and are taking aripiprizole.
• Children and teenagers between 10 and 18 years of age who have a conduct disorder and are taking risperidone.
• Children and teenagers between 10 and 18 years of age who have a conduct disorder and are not taking an atypical antipsychotic.
• Healthy volunteers between 10 and 18 years of age.

Design:

• Participants will be screened with a physical exam and medical history. Parents/guardians will be asked questions about their child s feelings, experiences, and behavior. Participants will also answer questions about their feelings and
  

  Detailed Summary:

  Objective: To determine the impact, as indexed by BOLD response, of the administration of aripiprazole and risperidone during the treatment of Conduct Disorder (CD) on the pathophysiology of CD.

  Study Population: Youth with CD receiving aripiprazole at admission to Boys Town Omaha, youth with CD receiving risperidone at admission to Boys Town Omaha, youth with CD not receiving antipsychotics at admission to Boys Town Omaha, typically developing youth.

  Design: The study will involve a 4 (Group: CD receiving aripiprazole at admission, CD receiving risperidone at admission, CD not receiving antipsychotics at admission, typically developing youth) x 2 (Time: At admission vs. four months subsequent to admission [when treatment for the antipsychotic groups will have been tapered off]) design. Principle dependent measures will relate to BOLD response indices of the pathophysiology of CD.

  Outcome Measures: Principle dependent measures will relate to BOLD response indices of the pathophysiology of CD. In addition, assessments of symptom severity will be collected, as will measurements of cognitive function.

  
  Sponsor: National Institute of Mental Health (NIMH)
  

  Current Primary Outcome: Principle dependent measures will relate to BOLD response indices of the pathophysiology of CD. [ Time Frame: ongoing ]
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome:
  
  Information By: National Institutes of Health Clinical Center (CC)
  

  Dates:
  Date Received: May 31, 2013
  Date Started: April 29, 2013
  Date Completion:
  Last Updated: April 19, 2017
  Last Verified: May 18, 2015