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

NCT01867398 | Terminated

• 2 other identifiers: 99991312513-M-N125
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Conduct Disorder; fMRI

Keywords

Conduct Disorder; Antipsychotic; Treatment Study; Functional Magnetic Resonance Imaging (fMRI); Adolescents

Outcome Measures

Primary Outcomes (1)

• Principle dependent measures will relate to BOLD response indices of the pathophysiology of CD.

  ongoing

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Youth with Conduct Disorder (CD)
• years of age.
• A current diagnosis of CD.
• Currently taking aripiprazole, risperidone or unmedicated with antipsychotics.
• Typically developing (TD) youth
• years of age.
• No current psychiatric diagnosis.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead
• Boys Town Research Hospital: collaborator

Study Sites (1)

Boys Town Research Hospital

Omaha, Nebraska, United States

Location

Related Publications (3)

• Allison DB, Casey DE. Antipsychotic-induced weight gain: a review of the literature. J Clin Psychiatry. 2001;62 Suppl 7:22-31.

  PMID: 11346192 BACKGROUND

• 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.

  PMID: 12153826 BACKGROUND

• 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.

  PMID: 17265076 BACKGROUND

MeSH Terms

Conditions

Conduct Disorder

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• James J Blair, Ph.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2013
• First Posted: June 4, 2013
• Study Start: April 29, 2013
• Primary Completion: May 18, 2015
• Study Completion: May 18, 2015
• Last Updated: December 12, 2019

Record last verified: 2015-05-18

Locations

US (1)