Protocol Number: 09-M-0176

Title:

Functional Relevance of Dopamine Receptors in Healthy Controls and Patients with Schizophrenia: Characterization through [11C]NNC-112 and [18F]Fallypride Positron Emission Tomography

Number:

09-M-0176

Summary:

Background:

- Some illnesses, such as schizophrenia, have effects on brain cells called dopamine receptors, which are required for normal brain function. People with schizophrenia have difficulty thinking and experience hallucinations and delusions. Medications that change brain dopamine receptors can decrease these hallucinations and delusions.

- The cause of schizophrenia and its association with brain dopamine receptors is not known but may be clarified by studying dopamine receptors in people who have dopamine disorders (such as schizophrenia) and those who do not. Researchers are interested in studying the dopamine system to gain a better idea of how dopamine disorders develop, which may lead to better medical care for people with schizophrenia.

Objectives:

- To study the amount and distribution of two types of dopamine receptors.

Eligibility:

- Individuals between the ages of 18 and 55 who have schizophrenia.

- Healthy volunteers between the ages of 18 and 90.

Design:

- Participants will undergo a full screening, with physical and psychological history, a neurological examination, and blood and urine samples.

- Participants will have a blood flow map of the brain recorded with a positron emission tomography (PET) brain scan. A magnetic resonance imaging (MRI) scan will also be performed to determine brain anatomy.

- To study the amount and distribution of dopamine receptors in the brain, participants will receive a small amount of a radioactive chemical in the vein, followed by a PET scan.

- The procedure will be performed twice in two separate sessions, once for [18F]fallypride and once for [11C]NNC-112.

Sponsoring Institute:

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

-Subjects will be recruited among individuals volunteering for NIH protocol 95-M-0150, NIH protocol 00-M-0085, or NIH protocol 89-M-0160.

-Only adult subjects who are able to provide informed consent will be studied.

-Patients will be between 18 and 55 years of age. Healthy controls will be matched by age and sex to the patients.

- Control subjects must be healthy based on history, laboratory and physical exam obtained through the above mentioned protocols.

- Patients with current psychiatric illness (schizophrenia, schizoaffective disorder, or other psychotic disorder)

- Current or prior use (or abuse) of substances that interfere with central dopaminergic signaling (e.g. antipsychotics, dopamine receptor agonists, catechol-o-methyltransferase inhibitors, anticholinergics, MAO-B inhibitors)

EXCLUSION CRITERIA:

-Subjects will be excluded if they don't fit the study requirements regarding age, ability to provide informed consent, absence of significant general medical, neurological or psychiatric disorders (except the disorder object of study), or intake of substances that interfere with central dopaminergic signaling.

-Controls with current or prior use (or abuse) of substances that interfere with central dopaminergic signaling (e.g. antipsychotics, dopamine receptor agonists, catechol-o-methyltransferase inhibitors, anticholinergics, MAO-B inhibitors)

-Controls with current psychiatric illness other than schizophrenia, schizoaffective disorder, or other psychotic disorder

-Secondary causes of schizophrenia-like syndromes, e.g. amphetamine abuse, brain infarction, tumor, or trauma

-Neurological disorders except those of exclusively peripheral location

-Significant prior or current substance abuse, severe systemic disease, hypothyroidism not compensated by medication

-Laboratory tests with clinically significant abnormalities

-History of a significantly abnormal EEG, cranial CT or MRI

-Conditions that increase risk for MRI (pacemaker devices, ferromagnetic metal implants, etc.)

-Prior participation in other research protocols such that radiation exposure would exceed the annual NIH RSC limits

-Prior participation in other research protocols such that radiation exposure would exceed the annual NIH RSC limits

Special Instructions:

Currently Not Provided

Keywords:

PET Study

(18F) Fallypride

(11C)NNC-112

Schizoaffective Disorder

Schizophrenia

Recruitment Keyword(s):

Schizophrenia

Schizoaffective Disorder

Healthy Volunteer

HV

Condition(s):

Schizoaffective Disorder

Schizophrenia

Investigational Drug(s):

[11C]NNC-112

[18F]Fallypride

[150]Water

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):

Sullivan PF, Neale MC, Kendler KS. Genetic epidemiology of major depression: review and meta-analysis. Am J Psychiatry. 2000 Oct;157(10):1552-62.

Tan HY, Callicott JH, Weinberger DR. Dysfunctional and compensatory prefrontal cortical systems, genes and the pathogenesis of schizophrenia. Cereb Cortex. 2007 Sep;17 Suppl 1:i171-81.

Weinberger DR. Schizophrenia drug says goodbye to dopamine. Nat Med. 2007 Sep;13(9):1018-9.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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