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| Name | Class |
|---|---|
| Ortho-McNeil Janssen Scientific Affairs, LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concerta | Experimental | The subject will be administered their usual dose of Concerta the morning of the FMRI scan in a double blind fashion |
|
| Placebo | Placebo Comparator | The subject will be administered a placebo the morning of the FMRI scan in a double blind fashion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methylphenidate-OROS | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Brain Oxygenation Level Dependent Signal in the Fusiform Gyrus and the Amygdala on Concerta vs. Placebo | Each subject viewed shapes and faces on multiple trials. The subject matched faces or shapes on each trial. BOLD activity during shape trials was subtracted from BOLD activity during Face trials and this value was compared on drug vs. placebo trials. | Placebo and Drug day, 1-2 weeks apart |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven R Pliszka, MD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Psychiatry, UTHSCSA | San Antonio | Texas | 78229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18180434 | Background | 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. | |
| 16741206 |
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Psychiatric assessment was performed to confirm the diagnosis of ADHD. Fifteen (15) patients were screen failures. Five (5) patients did not respond to an open label trial of Concerta were excluded. 11 withdrew consent or lost to follow up. (1) withdrew to claustrophobia. 43 were exposed to study drug (Concerta and placebo) in crossover design.
A total of 75 patients were enrolled from 11/4/2008 t0 8/12/2010. Patients were recruited from advertisements in local papers as well as flyers in the UTHSCSA psychiatric clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adults | These were participants between the age of 21-25 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design. |
| FG001 | Children | These were participants between the age of 3- 17 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adults | These were participants between the age of 21-25 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design. |
| BG001 | Children |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Brain Oxygenation Level Dependent Signal in the Fusiform Gyrus and the Amygdala on Concerta vs. Placebo | Each subject viewed shapes and faces on multiple trials. The subject matched faces or shapes on each trial. BOLD activity during shape trials was subtracted from BOLD activity during Face trials and this value was compared on drug vs. placebo trials. | The number who completed both fMRI one week apart (crossover study, scanned twice | Posted | Mean | Standard Deviation | Face-Shape BOLD signal difference | Placebo and Drug day, 1-2 weeks apart |
|
Adverse events were collected on the day of the scans.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adults | These were participants between the age of 21-25 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design. |
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No typically developing control group compared to either the adult or child group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven R. Pliszka MD | University of Texas Health Science Center at San Antonio | 210-567-5475 | pliszka@uthscsa.edu |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Placebo | 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. |
|
| 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. |
These were participants between the age of 3- 17 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
This is the BOLD signal data on the Placebo day scan.
| OG002 | Children Drug Condition | This is the BOLD signal data on the Concerta day scan. |
| OG003 | Children Placebo Condition | This is the BOLD signal data on the Placebo day scan. |
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Children | These were participants between the age of 3- 17 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design. | 0 | 26 | 0 | 26 |
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