USDOE Human Subjects Research Database, fiscal year 1995

Brookhaven National Laboratory

Project Identifier: BNL-94-144F

Project Title:

Evaluation of 18-FDG in the Diagnosis of Glucose Metabolism in the Human Body (Schizophrenics)

Principle Investigator: Dr. Joanna S. Fowler

Project started in: 1994

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.

Funding Sources:

DOE: Office of Health and Environmental Research (OHER)

Amount: $30,000 (Est.)

Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Full Board
Most Recent Approval: January 04, 1995

Number of Human Subjects in the Last Reporting Period for this Project: 3
(Reporting periods vary.)

Type of Human Subjects Involvement:

Ionizing Radiation and Radioactive Substances:

External use of ionizing radiation on human subjects.

• For clinical research.

Internal administration of radioactive substances to human subjects.

• For clinical research.

Chemical Substances:

Internal use of chemical substances (solid, liquid, or gas) in human subjects.

• For clinical research.

Collection of Bodily Materials:

Collection of personally identifiable bodily materials (blood or blood products, cells, tissue, organs, waste).

• Use of bodily materials collected from subjects specifically for this project.

(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

These studies are a continuation of our examination of the effect of the haloperidol challenge in neuroleptic-responsive and resistant schizophrenic subjects. We have hypothesized that responsive subjects will show a metabolic response to the haloperidol challenge similar to that observed in normals, whereas resistant subjects will fail to show this response. These studies may help us to manage individuals suffering from this disorder by further characterizing the disorder and finding more appropriate medication for the non-responsive group.

Approximately 20 schizophrenics and 10 normals will be studied. Each subject will receive a baseline F-18-Fluorodeoxyglucose (18-FDG) scan and be given a 5 milligram (mg) haloperidol challenge 12 hours prior to the second 18-FDG scan. The subjects have a short-lived positron emitter tracer administered and are subsequently scanned with positron emission tomography (PET). A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. Whenever blood is removed or a substance is injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues. Several uncomfortable reactions may occur following the administration of haloperidol: sedation, listlessness, decreased motivation, decreased blood pressure, painful muscular contractions, allergic drug reactions, dry mouth or blurred vision. Muscular reactions can and will be relieved with benztropine.