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

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01858064

Collaborator

(none)

Enrollment

Location

Arm

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
ADHD	Drug: OROS-MPH	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Adult Investigator Rating Scale [Baseline to 6 weeks]
AISRS

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator: Thomas Spencer, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thomas J. Spencer, MD, Principal Investigator, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT01858064

Other Study ID Numbers:

2013000956

First Posted:

May 20, 2013

Last Update Posted:

Apr 28, 2015

Last Verified:

Apr 1, 2015

Keywords provided by Thomas J. Spencer, MD, Principal Investigator, Massachusetts General Hospital

ADHD

OROS-MPH

Adults

Functional Magnetic Resonance Imaging

Study Results

No Results Posted as of Apr 28, 2015