Effects of Atypical Antipsychotics on Brain Function in Children and Teens With Conduct Disorders
|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.|
|ClinicalTrials.gov Identifier: NCT01867398|
Recruitment Status : Terminated
First Posted : June 4, 2013
Last Update Posted : April 17, 2018
- 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.
- To see how atypical antipsychotics affect brain activity of children and teenagers with conduct disorders.
- 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.
- 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 or disease|
|Conduct Disorder fMRI|
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.
|Study Type :||Observational|
|Actual Enrollment :||12 participants|
|Official Title:||The Investigation of the Impact of Atypical Antipsychotics on Brain Functioning in Youths With Conduct Disorder|
|Study Start Date :||April 29, 2013|
|Actual Primary Completion Date :||May 18, 2015|
|Actual Study Completion Date :||May 18, 2015|
- Principle dependent measures will relate to BOLD response indices of the pathophysiology of CD. [ Time Frame: ongoing ]
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): NCT01867398
|United States, Nebraska|
|Boys Town Research Hospital|
|Omaha, Nebraska, United States|
|Principal Investigator:||James J Blair, Ph.D.||National Institute of Mental Health (NIMH)|