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Neuroimaging of the Effects of Concerta in the Treatment of ADHD

NCT ID: NCT00778310

Last Updated: 2012-07-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-12-31

Brief Summary

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A number of brain regions have been down to be altered in both structure and function in patients with ADHD, including prefrontal cortex, anterior cingulate, caudate and cerebellum. Patients with ADHD often show reduced levels of activity in the frontal and cingulate regions of brain while performing measures of inhibitory control during functional magnetic resonance imaging (fMRI). While stimulant medications robustly improve the clinical symptoms of ADHD, there are only a small number of studies examining the effects of these commonly prescribed medications on brain activity. We propose to obtain fMRI in patients with ADHD on placebo and on their individualized dose of OROS methylphenidate (Concerta). Our hypothesis is that Concerta will increase the activity of the brain in the frontal, cingulate and amygdala of the brain and that these brain changes will be associated with clinical improvement of symptoms.

Detailed Description

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Three age groups of subjects will be studied: school age children (aged 9-12), older adolescents (age 15-17 years) and young adults (age 20-25 years). Twenty subjects will be studied in each group. All subjects must meet criteria for ADHD, combined type and be either treatment naïve or currently taking and responding well to Concerta. Child and adolescent patients taking Concerta will have their current levels of ADHD symptoms assessed with the Dupaul ADHD rating scale (11); adults taking Concerta will be assessed with Conners Adult ADHD Rating Scale (CAARS). Patients whose symptoms are in remission as evidenced by scores in the normal range on these scales may proceed directly to the neuroimaging portion of the study. Subjects who are treatment naïve or are treated but are not in remission shall under a three week open label trial of Concerta to determine the optimal dose for treatment of their symptoms.

Subjects will have two fMRI sessions on different days. During each fMRI session, they will perform both the Stop Signal Task and the Emotional Conflict Resolution Task . On the morning of the scan, placebo and Concerta will be administered in a double-blind, crossover design, with order of medication and placebo randomized. The scan sessions will take place between 3 and 7 hours after medication administration. After each scan, the subject and a research assistant will go to a quiet room in the imaging center; the subjects will be given arithmetic level set at a level of difficulty that the subject has mastered. The subject will be given 15 minutes to complete as many problems as possible.

Conditions

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Attention Deficit Disorder With Hyperactivity

Keywords

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Attention Deficit Disorder with Hyperactivity Attention Deficit Hyperactivity Disorder ADHD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Concerta

The subject will be administered their usual dose of Concerta the morning of the FMRI scan in a double blind fashion

Group Type EXPERIMENTAL

methylphenidate-OROS

Intervention Type DRUG

The collaborator (Ortho-McNiel Janssen Scientific Affairs, LLC) will provide capsules of Concerta that are made to appear similar to placebo capsules. The subject will be administered their usual dose of Concerta the morning of the scan.

Placebo

The subject will be administered a placebo the morning of the FMRI scan in a double blind fashion

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The collaborator (Ortho-McNiel Janssen Scientific Affairs, LLC) will provide capsules of placebo that are made to appear similar to Concerta capsules. The subject will be administered placebo the morning of the scan.

Interventions

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methylphenidate-OROS

The collaborator (Ortho-McNiel Janssen Scientific Affairs, LLC) will provide capsules of Concerta that are made to appear similar to placebo capsules. The subject will be administered their usual dose of Concerta the morning of the scan.

Intervention Type DRUG

Placebo

The collaborator (Ortho-McNiel Janssen Scientific Affairs, LLC) will provide capsules of placebo that are made to appear similar to Concerta capsules. The subject will be administered placebo the morning of the scan.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Meets DSM-IV criteria for Attention Deficit Hyperactivity Disorder
* Current clinical responder to Concerta (OROS-methylphenidate)

Exclusion Criteria

* IQ \< 95
* Presence of Learning Disorder
* Presence of an Affective or Psychotic Disorder
* Presence of a Substance/Alcohol Abuse/Dependence Disorder
* Presence of an Autism Spectrum Disorder
* Presence of a Tic Disorder
* Taking any psychotropic medication other than Concerta
* A medical condition requiring daily medication
* Previous adverse or non response to Concerta
Minimum Eligible Age

9 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ortho-McNeil Janssen Scientific Affairs, LLC

INDUSTRY

Sponsor Role collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven R Pliszka, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

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Dept of Psychiatry, UTHSCSA

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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Bush G, Spencer TJ, Holmes J, Shin LM, Valera EM, Seidman LJ, Makris N, Surman C, Aleardi M, Mick E, Biederman J. Functional magnetic resonance imaging of methylphenidate and placebo in attention-deficit/hyperactivity disorder during the multi-source interference task. Arch Gen Psychiatry. 2008 Jan;65(1):102-14. doi: 10.1001/archgenpsychiatry.2007.16.

Reference Type BACKGROUND
PMID: 18180434 (View on PubMed)

Pliszka SR, Glahn DC, Semrud-Clikeman M, Franklin C, Perez R 3rd, Xiong J, Liotti M. Neuroimaging of inhibitory control areas in children with attention deficit hyperactivity disorder who were treatment naive or in long-term treatment. Am J Psychiatry. 2006 Jun;163(6):1052-60. doi: 10.1176/ajp.2006.163.6.1052.

Reference Type BACKGROUND
PMID: 16741206 (View on PubMed)

Other Identifiers

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CONCERTAATT4087

Identifier Type: -

Identifier Source: org_study_id