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

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01858064
• Other study ID #: 2013000956
• Status: Withdrawn
• Phase: Phase 4
• First received: May 16, 2013
• Last updated: April 27, 2015
• Start date: April 2015
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adult Investigator Rating Scale	AISRS	Baseline to 6 weeks	No