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WithdrawnNCT02247986Updated Dec 3, 2019

Investigating the Impact of Methylphenidate on Neural Response in Disruptive Behavioral Disorder

A Phase 1/2 interventional study of Methylphenidate Hydrochloride in Conduct Disorder and Attention Defict Hyperactivity Disorder, sponsored by National Institute of Mental Health (NIMH). Withdrawn. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-12-03.

Sponsored by National Institute of Mental Health (NIMH) · Phase 1/2, Interventional, and Other

Phase
Phase 1/2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
10 Years to 17 Years
Sex
All
01

Study summary

Background:

  • Disruptive behavior is a common problem for children and adolescents. It can be treated with some success with stimulant medicine. Researchers want to learn more about how this works.

Objective:

  • To learn how the brain changes when taking the medicine methylphenidate for behavior problems.

Eligibility:

  • Children ages 10 17 with conduct disorder and/or attention deficit disorder.
  • Healthy volunteers the same age.

Design:

  • Participants will be screened under a separate protocol.
  • Participants will have two 3-hour sessions at the clinic. Girls who are menstruating will have a pregnancy test before their scans.
  • Visit 1: All participants will:
  • Perform simple tests on a computer.
  • Fill out a questionnaire along with their parent or guardian.
  • Have an MRI scan. A magnetic field and radio waves take pictures of the brain. Participants will lie on a table that slides into a metal cylinder. A coil will be placed over their head. They will be in the scanner for 60 minutes, lying still or performing a simple task. They will practice the task before the scan. A computer screen will show them task information during the scan. The scanner makes loud knocking sounds. Participants will get earplugs. Their parent or guardian can stay with them during the scan.
  • Only participants with behavior disorders will:
  • Take a pill of the study medicine or placebo.
  • Be monitored for any side effects.
  • Visit 2 is a repeat of Visit 1, except participants who got a pill in Visit 1 will get the other pill in Visit 2. For healthy volunteers, the 2 visits are exactly the same.
Read the detailed description

OBJECTIVE:

To determine the impact, as indexed by BOLD response, of the administration of dopaminergic agonist (methylphenidate) on the pathophysiology of CD/ODD.

STUDY POPULATION:

Youth with CD/ODD and typically developing (TD) youth.

DESIGN:

The study will involve a 2 session design (methylphenidate [MPH] vs. placebo). Patients with CD/ODD will participate in both sessions. TD youth will be tested for 2 sessions (no medication) to provide an index of typical task response. Activity within regions of interest identified from the TD youth will be used to determine whether MPH reduces differences in BOLD response in CD/ODD relative to TD youth. ICU scores and current ADHD symptomatology will be used as covariates to determine whether these variables moderate the putative increase in BOLD response in target regions in the patients with CD.

OUTCOME MEASURES:

Principle dependent measures will be BOLD responses as measured through core tasks.

02

Conditions studied

  • Conduct Disorder
  • Attention Defict Hyperactivity Disorder

Keywords

  • Conduct Disorder
  • Methylphenidate
  • Disruptive Behavior Disorders
03

In context

Conduct Disorder

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

Browse Conduct Disorder studies →

Lead sponsor

National Institute of Mental Health (NIMH) is the lead sponsor of 367 studies on the registry; 45 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 24 (96%) have results posted.

Browse National Institute of Mental Health (NIMH) studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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 CD

  1. 10-17 years of age.

  2. A current diagnosis of CD as determined by the Kiddie-SADS, lifetime version.

    • Youth in the CD+comorbid ADHD group will also meet diagnostic criteria for ADHD.
    • Youth in the CD without comorbid ADHD group will specifically not meet diagnostic criteria for ADHD.
  3. Youth with CD shouldmust be na(SqrRoot) ve to psychoactive medication (such as: methylphenidate and amphetamine).

TD youth

  1. 10-17 years of age.
  2. No current psychiatric diagnosis, as determined by the Kiddie-SADS, lifetime version.

Exclusion criteria

EXCLUSION CRITERIA

Exclusion criteria for youth with CD (with or without ADHD)

  1. Comorbid psychotic, major mood, tic, pervasive developmental, and substance abuse disorders.
  2. Presence of comorbid ADHD is exclusory for the group of patients with CD without ADHD
  3. History of known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems
  4. Current weight less than 25kg or over 90kg

Exclusion criteria for all participants (CD with ADHD, CD without ADHD and TD)

  1. History of serious CNS disease disorder (examples aresuch as: history of seizure, epilepsy, brain tumor, brain hemorrhage, and major CNS infection such as meningitis or encephalitis)
  2. Previous history of known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems
  3. Current use of any psychiatric medications and centrally acting medications (such as stimulants, non-stimulant ADHD medications, antidepressants, anxiolytics, antipsychotics and anti-epilepsy medications), and past history of use of psychoactive medication (such as methylphenidate and amphetamine)
  4. A positive urine pregnancy test
  5. A Positive urine toxicology, History/current diagnosis of substance abuse/dependence
  6. Suicidal or homicidal ideation within the past 6 months.
  7. Wechsler Abbreviated Scale of Intelligence (WASI) (D. Wechsler, 1999) scores \<70
  8. Metal in body (i.e., hearing aid, cardiac pacemaker, bone plates, etc), claustrophobia, or any other condition that would preclude fMRI scanning.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
0 participants (actual)

Interventions

06

What researchers measure

Primary outcomes

  1. Patients with CD will show an increase in the amygdala response to fearful expressions such that the difference between BOLD response in patients and TDs is reduced on MPH relative to placebo. ICU score will be a significant covariate of the inc...

    Time frame: 2 years from the initiation of the protocol

  2. Patients with CD will show an increase in reward prediction errors and reward expected value signaling within striatum and ventromedial frontal cortex (vmPFC) such that the difference between BOLD response in patients and TDs is reduced on MPH r...

    Time frame: 2 years from the initiation of the protocol

  3. Patients with CD will show an increase in conflict related signaling within dorsomedial, lateral and parietal cortices such that the difference between BOLD response in patients and TDs is reduced on MPH relative to placebo. Current ADHD sympto...

    Time frame: 2 years from the initiation of the protocol

Secondary outcomes

  1. Symptom profiles measured by the clinical scales listed in the protocol (CBCL, the ICU, Connor s parent report on ADHD symptom) will be significantly related to the BOLD signal changes after methylphenidate administration.

    Time frame: 2 years from the initiation of the protocol

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Waschbusch DA, Carrey NJ, Willoughby MT, King S, Andrade BF. Effects of methylphenidate and behavior modification on the social and academic behavior of children with disruptive behavior disorders: the moderating role of callous/unemotional traits. J Clin Child Adolesc Psychol. 2007 Oct-Dec;36(4):629-44. doi: 10.1080/15374410701662766. PubMed 18088220 ↗
  • Blair RJ. Neurocognitive models of aggression, the antisocial personality disorders, and psychopathy. J Neurol Neurosurg Psychiatry. 2001 Dec;71(6):727-31. doi: 10.1136/jnnp.71.6.727. PubMed 11723191 ↗
  • White SF, Pope K, Sinclair S, Fowler KA, Brislin SJ, Williams WC, Pine DS, Blair RJ. Disrupted expected value and prediction error signaling in youths with disruptive behavior disorders during a passive avoidance task. Am J Psychiatry. 2013 Mar;170(3):315-23. doi: 10.1176/appi.ajp.2012.12060840. PubMed 23450288 ↗
09

Timeline

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

The record gives a start of Sep 2014, 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
Sep 20, 2014
First posted
Sep 25, 2014
Start
Sep 4, 2014
Primary completionActual
May 18, 2015
CompletionActual
May 18, 2015
Last update
Dec 3, 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 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02247986
Lead sponsor
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Sep 25, 2014
Start date
Sep 4, 2014
Primary completion
May 18, 2015
Completion
May 18, 2015
Last update
Dec 3, 2019

Study contacts

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

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

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