Predicting Treatment Response to Stimulants in Adult ADHD Using Functional Magnetic Resonance Imaging

Study Overview
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Brief Summary
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The primary aim of this study is to assess the predictability of treatment response to stimulants in adults with ADHD using functional magnetic resonance This study will be a six-week, open-label study including adults ranging from age 18-55 with ADHD.

Detailed Description
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Certain brain characteristics have been identified in individuals with persistent and remitted ADHD. We predict that neural functional connectivity; specifically decreases in connectivity between the posterior cingulated cortex and medial prefrontal cortex, as well as decreases in anticorrelations between the medial prefrontal cortex and dorsolateral prefrontal cortex, will predict greater response to stimulant treatment.

Official Title
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Predicting Treatment Response to Stimulants in Adult ADHD Using Functional Magnetic Resonance Imaging

Conditions
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ADHD

Intervention / Treatment
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* Drug: OROS-MPH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female adults ages 18-55 years Right handed A diagnosis current of childhood onset ADHD, according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) based on clinical assessment A score of > 20 on the Adult ADHD Investigator Symptom Report Scale (AISRS) or a CGI-Severity score of > 4 (moderate severity) Exclusion Criteria: A history of non-response or intolerance to stimulants at adequate doses as determined by the clinician Pregnant or nursing females Serious, unstable medical illnesses including hepatic, renal, gastroenterological, respiratory, cardiovascular, endocrinologic (thyroid), neurologic (seizure), immunologic, or hematologic disease Glaucoma Clinically unstable psychiatric conditions including suicidality, homocidality, bipolar disorder, psychosis, or lifetime history of a clinically serious condition potentially exacerbated by a stimulant, such as mania or psychosis Tics or diagnosis of Tourette's syndrome Current (within 3 months) DSM-IV criteria for abuse or dependence with any psychoactive substance other than nicotine Current use of psychotropic medications Current use of MAO Inhibitor or use within the past two weeks Claustrophobia or an standard contraindications to MRI scanning (metal in body) Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent or grandchild

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OROS-MPH<br>OROS-MPH is administered in capsule form daily, beginning at 36 mg/day and titrated on a weekly basis for 3 weeks in increments of 18-36 mg/day to a maximum daily dose of 90mg/day. | Drug: OROS-MPH<br>* Capsule administered daily, beginning at 36 mg/day and titrated on a weekly basis for 3 weeks in increments of 18-36 mg/day to a maximum daily dose of 90 mg/day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adult Investigator Rating Scale | AISRS | Baseline to 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, OROS-MPH, Adults, Functional Magnetic Resonance Imaging