Protocol Number: 06-M-0246

Title:

PET Scanning of Brain Dopaminergic Signal Transduction Involving Arachidonic Acid in Adults with Attention Deficit Hyperactivity Disorder (ADHD)

Number:

06-M-0246

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:

" Medical history and psychiatric and medical evaluation, including blood and urine tests.

" 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.

" 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.

Sponsoring Institute:

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male

Referral Letter Required: No

Population Exclusion(s): Female

Children

Eligibility Criteria:

INCLUSION CRITERIA:

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 for both normal volunteers and ADHD subjects. Primary efforts will be to recruit adults with ADHD who currently are untreated and psychotropic medication naive. However, subjects with a history of exposure to psychotropic compounds will be considered if that exposure was limited to brief medication trials (less than one month duration) and sufficiently removed in time from the scans (6 months). We will not be asking subjects to stop ongoing medication treatment to enroll. In the analyses we will consider history of previous stimulant exposure, through either stratification or as a covariate. Additionally, stimulant-free periods of at least 1 month will be required before the experimental procedures in phase II of the study. 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.

EXCLUSION CRITERIA:

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.

Special Instructions:

Currently Not Provided

Keywords:

Phospholipase A2

D2 Receptors

Apomorphine

Trimethobenzamide

Recruitment Keyword(s):

Attention Deficit Hyperactivity Disorder

ADHD

Healthy Volunteer

HV

Condition(s):

Volunteer

Attention Deficit Hyperactivity Disorder

Investigational Drug(s):

[15O]H2O

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Mental Health

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

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.

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.

Axelrod J. Phospholipase A2 and G proteins. Trends Neurosci. 1995 Feb;18(2):64-5.

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