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

Primary Purpose

ADHD

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
OROS-MPH
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD focused on measuring ADHD, OROS-MPH, Adults, Functional Magnetic Resonance Imaging

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OROS-MPH

Arm 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.

Outcomes

Primary Outcome Measures

Adult Investigator Rating Scale
AISRS

Secondary Outcome Measures

Full Information

First Posted
May 16, 2013
Last Updated
April 27, 2015
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01858064
Brief Title
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

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Competing Departmental Studies
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
ADHD, OROS-MPH, Adults, Functional Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OROS-MPH
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
OROS-MPH
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adult Investigator Rating Scale
Description
AISRS
Time Frame
Baseline to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Spencer, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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