- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01867398
Effects of Atypical Antipsychotics on Brain Function in Children and Teens With Conduct Disorders
The Investigation of the Impact of Atypical Antipsychotics on Brain Functioning in Youths With Conduct Disorder
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Nebraska
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Omaha, Nebraska, United States
- Boys Town Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA:
Youth with Conduct Disorder (CD)
- 10-18 years of age.
- A current diagnosis of CD.
- Currently taking aripiprazole, risperidone or unmedicated with antipsychotics.
Typically developing (TD) youth
- 10-18 years of age.
- No current psychiatric diagnosis.
EXCLUSION CRITERIA:
- I.Q.< 80.
- Pregnancy.
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Principle dependent measures will relate to BOLD response indices of the pathophysiology of CD.
Time Frame: ongoing
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ongoing
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Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- Allison DB, Casey DE. Antipsychotic-induced weight gain: a review of the literature. J Clin Psychiatry. 2001;62 Suppl 7:22-31.
- Aman MG, De Smedt G, Derivan A, Lyons B, Findling RL; Risperidone Disruptive Behavior Study Group. Double-blind, placebo-controlled study of risperidone for the treatment of disruptive behaviors in children with subaverage intelligence. Am J Psychiatry. 2002 Aug;159(8):1337-46. doi: 10.1176/appi.ajp.159.8.1337.
- Bortolozzi A, Diaz-Mataix L, Toth M, Celada P, Artigas F. In vivo actions of aripiprazole on serotonergic and dopaminergic systems in rodent brain. Psychopharmacology (Berl). 2007 Apr;191(3):745-58. doi: 10.1007/s00213-007-0698-y. Epub 2007 Jan 30.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999913125
- 13-M-N125
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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