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

April 27, 2015 updated by: Thomas J. Spencer, MD, Massachusetts General Hospital

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OROS-MPH
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
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

May 16, 2013

First Submitted That Met QC Criteria

May 17, 2013

First Posted (Estimate)

May 20, 2013

Study Record Updates

Last Update Posted (Estimate)

April 28, 2015

Last Update Submitted That Met QC Criteria

April 27, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2013000956

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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