Clinical trial NCT01858064: Predicting Treatment Response to Stimulants in Adult ADHD Using Functional Magnetic Resonance Imaging
Official title: Predicting Treatment Response to Stimulants in Adult ADHD Using Functional Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: ADHD
Keywords: ADHD
OROS-MPH
Adults
Functional Magnetic Resonance Imaging
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2013-05-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adult Investigator Rating Scale
timeFrame: Baseline to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Thomas Spencer, MD
role: PRINCIPAL_INVESTIGATOR
References: