Brain Dopamine Function in Adults With ADHD (Brookhaven)

August 26, 2024 updated by: Coleen Cunningham, University of California, Irvine
The purpose of the study is to investigate the functional state of dopamine cells and the dopamine transporter in ADHD subjects and controls to assess the effects of chronic methylphenidate treatment on dopamine cell function and dopamine transporter levels in ADHD subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

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
    • California
      • Irvine, California, United States, 92612
        • UCI Child Development Center

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 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Must give informed consent
  • Must be between the ages of 18 and 45 years old.
  • Must have a confirmed diagnosis of ADHD
  • Must have scored on a rating scale that indicate a significant level of symptom severity.
  • Must have a childhood history of ADHD must be documented using established test criteria.
  • Must have had no previous medication treatment for ADHD except for a short term treatment period of less than three months, which should have occurred at least six months prior to the study.
  • Must have an interest in receiving long-term medication treatment for ADHD.

Exclusion Criteria:

  • Must not test positive for psychoactive drugs during a urine drug screen.
  • Must not be pregnant.
  • Must not be breastfeeding.
  • Must have no past or present history of dependence on alcohol or other drugs of abuse except nicotine or caffeine.
  • Must have no past or present history of a psychiatric disorder except ADHD.
  • Must have no medical illness that may affect brain function.
  • Must not have taken medication that may affect brain function.
  • Must not have had head trauma with loss of consciousness (> 30 minutes).
  • Must not have significant anxiety or depression as determined by an established test.
  • Must have no history of a significant learning disability.
  • Must have no history of cardiovascular or endocrinological disease.
  • Must have no history of coagulation disorder.
  • Must have no history of sensitivity to lidocaine and/or prilocaine.
  • Must have no history of claustrophobia.
  • Contraindication to MRI environment (presence of any implanted metallic objects such as cardiac/neural pacemakers, defibrillators, aneurysm clips, certain heart valves, spinal nerve stimulators, artificial joints/limbs, shrapnel/bullets, metal fragments in their eyes, cochlear implants, hearing aids, dental implants).
  • Must have no history of glaucoma.

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: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: methylphenidate
intervention is methylphenidate once daily for 12 months, doses individually titrated
Drug: Experimental: methylphenidate treatment
subjects received mehtylphenidate treatment for 12 months
Other Names:
  • methylphenidate once daily for 12 months, doses individually titrated for efficacy
No Intervention: No medication
no methylphenidate treatment for non ADHD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DAT Availability
Time Frame: 1 year

Striatal DAT availability as noted in PET scans post one year of methylphenidate treatment or no intervention.

The unit listed as binding potential (BPND) was measured with a dynamic PET scan protocol, using carbon-11 labeled cocaine, a radioligand with specific binding to DAT (which is inhibited by drugs that block DAT but not by drugs that block the norephephrine or serotonin transporters). This radiotracer was utilized to quantify DAT availability as non-displaceable binding potential using a standard kinetic model for reversible ligands.

The dynamic PET scans were started immediately after injection of [11C]cocaine (specific activity 0.5-1.5 Ci/uM at end of bombardment). Arterial blood was obtained to measure the concentration of unchanged [11C] cocaine in plasma for quantification of DAT availability.
1 year

Collaborators and Investigators

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

Sponsor

University of California, Irvine

Collaborators

Icahn School of Medicine at Mount Sinai
Duke University

Investigators

  • Principal Investigator: Tim Wigal, Ph.D., UC Irvine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2006

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

October 4, 2007

First Submitted That Met QC Criteria

December 26, 2007

First Posted (Estimated)

December 27, 2007

Study Record Updates

Last Update Posted (Actual)

August 29, 2024

Last Update Submitted That Met QC Criteria

August 26, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20054659

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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