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

Mass General Brigham

Status and phase: Withdrawn; Phase 4

Conditions: ADHD

Treatments: Drug: OROS-MPH

Study type: Interventional

Funder types: Other

Identifiers

NCT01858064

2013000956

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

OROS-MPH

Experimental group

Description:

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.

Treatment:

Drug: OROS-MPH