ClinicalTrials.gg
Sign In
TerminatedNCT01867398Updated Dec 12, 2019

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

An observational study in Conduct Disorder and fMRI, sponsored by National Institute of Mental Health (NIMH). Terminated at 1 site in United States. Open to participants aged 10 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-12.

Sponsored by National Institute of Mental Health (NIMH) · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
12
Ages
10 Years to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 48 studies in Conduct Disorder with a site in United States — 5 open to participants now, 8 under way, none of them phase 3. Conduct Disorder · United States.

Started
2013
the only one that year
Observational
9 of 48
4 open now
Registered
27th of 48
by date
Lead sponsor
5 of 48
National Institute of Mental Health (NIMH)

Among the 48 studies in Conduct Disorder with a site in United States, this one is the only one that started in 2013, is one of 9 observational ones, and was the 27th registered.

Conduct Disorder

101 studies on the registry are indexed under Conduct Disorder; 15 are open to participants now.

Browse Conduct Disorder studies →

Open to participants now

5 of the 48 studies in Conduct Disorder with a site in United States are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 11 Conduct Disorder studies recruiting now, 1 (9%) set no upper age limit and 8 (73%) stop at 75 or younger; 10 take children under 18; 0 take healthy volunteers.

This study: 10 Years to 18 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 48 studies in Conduct Disorder with a site in United States, or all of them as a file.
02

Study 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.
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.

03

Conditions studied

  • Conduct Disorder
  • fMRI

Browse trials for

Keywords

  • Conduct Disorder
  • Antipsychotic
  • Treatment Study
  • Functional Magnetic Resonance Imaging (fMRI)
  • Adolescents
04

Who can participate

Ages eligible
10 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

EXCLUSION CRITERIA:

  1. I.Q.\< 80.
  2. Pregnancy.

  3. Ongoing medical illness requiring the following medications:

    • Beta blockers
    • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Time perspective
Prospective
Enrollment
12 participants (actual)
06

What researchers measure

Primary outcomes

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

    Time frame: ongoing

07

Study locations

1 site
  • Boys Town Research Hospital
    Omaha, Nebraska, United States
08

References and documents

Publications

  • Allison DB, Casey DE. Antipsychotic-induced weight gain: a review of the literature. J Clin Psychiatry. 2001;62 Suppl 7:22-31. PubMed 11346192 ↗
  • 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. PubMed 12153826 ↗
  • 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. PubMed 17265076 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2013, a primary completion of May 2015 and a completion of May 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 31, 2013
First posted
Jun 4, 2013
Start
Apr 29, 2013
Primary completionActual
May 18, 2015
CompletionActual
May 18, 2015
Last update
Dec 12, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01867398
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborators
Boys Town Research Hospital
Responsible party
Sponsor
First posted
Jun 4, 2013
Start date
Apr 29, 2013
Primary completion
May 18, 2015
Completion
May 18, 2015
Last update
Dec 12, 2019

Study contacts

James J Blair, Ph.D.
principal investigator · National Institute of Mental Health (NIMH)
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Conduct Disorder →

Other studies from this sponsor

National Institute of Mental Health (NIMH) →

Start the discussion