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

NCT01858064 | Withdrawn Phase 4

• 1 other identifier: 2013000956
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Adult Investigator Rating Scale

  AISRS

  Baseline to 6 weeks

Study Arms (1)

OROS-MPH

EXPERIMENTAL

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

Interventions

OROS-MPH DRUG

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.

OROS-MPH

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Thomas Spencer, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 16, 2013
• First Posted: May 20, 2013
• Study Start: April 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 28, 2015

Record last verified: 2015-04

Locations

US (1)