NCT00397748

Brief Summary

This study will explore the brain in men with and without attention deficit hyperactivity disorder (ADHD). It will use positron emission tomography (PET) and magnetic resonance imaging (MRI) to study brain function and nerve cell communication involving phospholipids (fatty molecules that make up the covering of nerve cell fibers in the brain and are involved in communication between the cells). It will also look at how nerve cell communication is related to blood flow. In particular, the study will explore communication through the dopamine system, which is one of the main neurotransmitter systems in the brain involved in ADHD. Healthy men and men with ADHD between 18 and 55 years of age may be eligible for this study. Participants undergo the following procedures: "\<TAB\>Medical history and psychiatric and medical evaluation, including blood and urine tests. "\<TAB\>MRI scan. This test uses a strong magnetic field and radio waves to obtain images of the brain. The subject lies still on a table that slides into the scanner (a metal cylinder) during the scanning. "\<TAB\>PET scanning. The subject lies on the scanner bed with his head held still using a special facemask. A catheter (plastic tube or needle) is placed in an artery to collect blood samples and in a vein to inject radioactive isotopes for measuring blood flow and phospholipid metabolism. Scans are done after an injection of a saline solution and again after injection of apomorphine, a medication that turns on dopamine receptors in the brain. The injections are given under the skin of the abdomen, about one and a half hours apart....

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2006

Completed
6.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2012

Completed
Last Updated

December 16, 2019

Status Verified

November 27, 2012

First QC Date

November 8, 2006

Last Update Submit

December 13, 2019

Conditions

Keywords

Phospholipase A2D2 ReceptorsApomorphineTrimethobenzamideAttention Deficit Hyperactivity DisorderADHDHealthy VolunteerHV

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All subjects must have normal values on screening measures to be in the study. They must be male and between 18 and 55 years of age. Primary efforts will also be to recruit non-smokers, given nicotine s ability to release dopamine presynaptically, a confound for this study. Previous smokers who have been abstinent for greater than 1 year may be considered.

You may not qualify if:

  • In addition to psychiatric criteria described above: past or current medical condition that would interfere with brain function - history of alcoholism, tobacco use (must have minimum of one year of full remission/complete abstinence from nicotine), neurological illness, head trauma with loss of consciousness, history of exposure to central nervous system toxin; history of central nervous system infection; metabolic, endocrine, connective tissue disease; hypertension or other cardiovascular disorder; gastrointestinal disorders; abnormal renal, liver or pulmonary function; blood dyscrasias; malignancy; nonstimulant or stimulant pharmacotherapy within 1 month of the study, or any history of antipsychotic medication; neurodegenerative or neurodevelopmental disorder; stroke; epilepsy; sensitivity to flashing lights; subjects requiring regular medication; subjects demonstrated by drug screening to have taken a controlled substance; subjects with a history of hypersensitivity to lidocaine; subjects with IQ less than 80. Females, adolescents and children will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Agid Y, Pollak P, Bonnet AM, Signoret JL, Lhermitte F. Bromocriptine associated with a peripheral dopamine blocking agent in treatment of Parkinson's disease. Lancet. 1979 Mar 17;1(8116):570-2. doi: 10.1016/s0140-6736(79)91003-1.

    PMID: 85162BACKGROUND
  • Amenta F, Ricci A, Tayebati SK, Zaccheo D. The peripheral dopaminergic system: morphological analysis, functional and clinical applications. Ital J Anat Embryol. 2002 Jul-Sep;107(3):145-67.

    PMID: 12437142BACKGROUND
  • Axelrod J. Phospholipase A2 and G proteins. Trends Neurosci. 1995 Feb;18(2):64-5. doi: 10.1016/0166-2236(95)93873-v. No abstract available.

    PMID: 7537411BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Judith L Rapoport, M.D.

    National Institute of Mental Health (NIMH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
OTHER
Sponsor Type
NIH

Study Record Dates

First Submitted

November 8, 2006

First Posted

November 9, 2006

Study Start

September 15, 2006

Study Completion

November 27, 2012

Last Updated

December 16, 2019

Record last verified: 2012-11-27

Locations