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

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

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01858064
Enrollment
0
Registered
2013-05-20
Start date
2015-04-30
Completion date
2015-04-30
Last updated
2015-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD

Keywords

ADHD, OROS-MPH, Adults, Functional Magnetic Resonance Imaging

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.

Interventions

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.

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Adult Investigator Rating ScaleBaseline to 6 weeksAISRS

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026