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Conduct DisorderPhase 1/2NCT02247986

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

A Phase 1/2 study testing Methylphenidate Hydrochloride in people with Conduct Disorder and Attention Defict Hyperactivity Disorder, run by National Institute of Mental Health (NIMH).

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 17 years
What is being tested?
Methylphenidate Hydrochloride
How many people
0 participants
Where
No sites listed yet
Study dates
4 Sep 2014to 18 May 2015
Phase
Phase 1/2
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 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Youth with CD
  • 10-17 years of age.
  • 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.
  • Youth with CD shouldmust be na(SqrRoot) ve to psychoactive medication (such as: methylphenidate and amphetamine).
Show all 9Show fewer
  • TD youth
  • 10-17 years of age.
  • No current psychiatric diagnosis, as determined by the Kiddie-SADS, lifetime version.

Who cannot join

  • Comorbid psychotic, major mood, tic, pervasive developmental, and substance abuse disorders.
  • Presence of comorbid ADHD is exclusory for the group of patients with CD without ADHD
  • History of known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems
  • Current weight less than 25kg or over 90kg
  • Exclusion criteria for all participants (CD with ADHD, CD without ADHD and TD)
  • 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)
Show all 13Show fewer
  • Previous history of known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems
  • 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)
  • A positive urine pregnancy test
  • A Positive urine toxicology, History/current diagnosis of substance abuse/dependence
  • Suicidal or homicidal ideation within the past 6 months.
  • Wechsler Abbreviated Scale of Intelligence (WASI) (D. Wechsler, 1999) scores <70
  • Metal in body (i.e., hearing aid, cardiac pacemaker, bone plates, etc), claustrophobia, or any other condition that would preclude fMRI scanning.

About this study

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.
Read more

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.

Being tested
Methylphenidate Hydrochloride
Keywords
Conduct Disorder, Methylphenidate, Disruptive Behavior Disorders
Medical subject headings
Conduct Disorder, Attention Deficit and Disruptive Behavior Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Methylphenidate HydrochlorideDrug

    Bold signal changes by methylphenidate on DBD

What is being measured

The primary outcome is the main question the study is designed to answer.

  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...

    Measured: 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...

    Measured: 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...

    Measured: 2 years from the initiation of the protocol

Secondary outcomes (1)

  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.

    Measured: 2 years from the initiation of the protocol

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2014 (estimated)
  2. Study start4 Sep 2014
  3. Primary completion18 May 2015
  4. Study completion18 May 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02247986
Sponsor's protocol ID
140193
Other IDs
14-M-0193
Status last verified
18 May 2015
First submitted
20 Sep 2014
Last updated
3 Dec 2019
Results posted
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Methylphenidate Hydrochloride in people with Conduct Disorder and Attention Defict Hyperactivity Disorder, run by National Institute of Mental Health (NIMH).

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 9 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: withdrawn, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

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). The study lists 3 primary outcomes in all. 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 NCT02247986, 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 3 Dec 2019.

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