Conduct DisorderNCT01867398
Effects of Atypical Antipsychotics on Brain Function in Children and Teens With Conduct Disorders
An observational study of Conduct Disorder and fMRI, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Conduct Disorder, fMRI
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2013to 18 May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- I.Q.< 80.
- Pregnancy.
- Ongoing medical illness requiring the following medications:
- Beta blockers
- Steroids
- Receipt of any antipsychotic medication other than aripiprazole or risperidone.
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Conduct Disorder, fMRI
- Keywords
- Conduct Disorder, Antipsychotic, Treatment Study, Functional Magnetic Resonance Imaging (fMRI), Adolescents
- Medical subject headings
- Conduct Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Principle dependent measures will relate to BOLD response indices of the pathophysiology of CD.
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study start29 Apr 2013
- Primary completion18 May 2015
- Study completion18 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Conduct DisorderStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Boys Town Research Hospital
- Responsible party
- Sponsor
- Investigators
- James J Blair, Ph.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867398
- Sponsor's protocol ID
- 999913125
- Other IDs
- 13-M-N125
- Status last verified
- 18 May 2015
- First submitted
- 31 May 2013
- Last updated
- 12 Dec 2019
- Results posted
- No
Publications
Allison DB, Casey DE. Antipsychotic-induced weight gain: a review of the literature. J Clin Psychiatry. 2001;62 Suppl 7:22-31.
PubMed 11346192Aman 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.
PubMed 12153826Bortolozzi 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.
PubMed 17265076
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of the Impact of Atypical Antipsychotics on Brain Functioning in Youths With Conduct Disorder
- ClinicalTrials.gov ID
- NCT01867398
- Acronym / sponsor ID
- 999913125
- Conditions
- Conduct Disorder, fMRI
- Keywords
- Conduct Disorder, Antipsychotic, Treatment Study, Functional Magnetic Resonance Imaging (fMRI), Adolescents
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 12 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Collaborators
- Boys Town Research Hospital
- Study start
- 29 Apr 2013
- Primary completion
- 18 May 2015 (actual)
- Study completion
- 18 May 2015 (actual)
- First posted
- 4 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- I.Q.< 80.
- Pregnancy.
- Ongoing medical illness requiring the following medications:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Principle dependent measures will relate to BOLD response indices of the pathophysiology of CD.
Time frame: ongoing
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Background: PubMed 11346192Allison DB, Casey DE. Antipsychotic-induced weight gain: a review of the literature. J Clin Psychiatry. 2001;62 Suppl 7:22-31.
- Background: PubMed 12153826Aman 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.
- Background: PubMed 17265076Bortolozzi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James J Blair, Ph.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Conduct Disorder and fMRI, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Principle dependent measures will relate to BOLD response indices of the pathophysiology of CD. (time frame: ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01867398, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019.