Trial record 20 of 37 for:    teen AND (violence OR aggression) | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier:
NCT01867398
First received: May 31, 2013
Last updated: April 8, 2014
Last verified: March 2014
  Purpose

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 moods.
  • This study will involve two visits. Each visit will involve MRI scanning.
  • At the first visit, participants will have memory and thinking tests. The tests will involve making decisions or playing games. Some of these tests will use MRI scanning to look at brain activity.
  • The second visit will be 3 to 5 months after the first visit. The tests from the first visit will be repeated.

Condition
Conduct Disorder
fMRI

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Investigation of the Impact of Atypical Antipsychotics on Brain Functioning in Youths With Conduct Disorder

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Principle dependent measures will relate to BOLD response indices of the pathophysiology of CD. [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 320
Study Start Date: April 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

Youth with Conduct Disorder (CD)

  1. 10-18 years of age.
  2. A current diagnosis of CD.
  3. Currently taking aripiprazole, risperidone or unmedicated with antipsychotics.

Typically developing (TD) youth

  1. 10-18 years of age.
  2. No current psychiatric diagnosis.

EXCLUSION CRITERIA:

  1. I.Q.< 80.
  2. Pregnancy.
  3. Ongoing medical illness requiring the following medications:

    • Beta blockers
    • Steroids
    • Receipt of any antipsychotic medication other than aripiprazole or risperidone.
    • Receipt of risperidone for the CD group medicated with aripiprazole.
    • Receipt of aripiprazole for the CD group medicated with risperidone.
    • Receipt of antipsychotics for the un-medicated CD group.
    • Explicit exclusions include active psychosis, Pervasive Developmental
    • Neurologic disorder (including seizures).
    • Any ferromagnetic metallic objects in the body. Metal plates, certain types of dental braces, cardiac pacemakers, etc., that are sensitive to electromagnetic fields contraindicate MRI scans.
    • Claustrophobia
  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 ClinicalTrials.gov identifier: NCT01867398

Contacts
Contact: James J Blair, Ph.D. (301) 496-5198 jamesblair@mail.nih.gov

Locations
United States, Nebraska
Boys Town Research Hospital Recruiting
Omaha, Nebraska, United States
Sponsors and Collaborators
Investigators
Principal Investigator: James J Blair, Ph.D. National Institute of Mental Health (NIMH)
  More Information

Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier: NCT01867398     History of Changes
Other Study ID Numbers: 999913125, 13-M-N125
Study First Received: May 31, 2013
Last Updated: April 8, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Conduct Disorder
Antipsychotic
Treatment Study
Functional Magnetic Resonance Imaging (fMRI)
Adolescents

Additional relevant MeSH terms:
Disease
Conduct Disorder
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 18, 2014