USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Berkeley National Laboratory


Project Identification:

Project Identifier: LBNL-90-110-H01

Project Title:

Hippocampal Metabolism in Schizophrenia

Principle Investigator: Dr. Thomas E. Nordahl

Project started in: 1990


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:

Non-DOE Federal: National Institute of Mental Health (NIMH)
Amount: $70,000 (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: August 14, 1995
IRB Approval Number: 95-6-108

Number of Human Subjects in the Last Reporting Period for this Project: 6
(Reporting periods vary.)

Type of Human Subjects Involvement:

Ionizing Radiation and Radioactive Substances:

Internal administration of radioactive substances to human subjects.

Collection of Bodily Materials:

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

Abstract:
(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])

OBJECTIVES

The objective of this study is to investigate hippocampal metabolism in schizophrenia, bipolar affective, and panic disorder, seeking to localize functional abnormalities. The study proposes to test whether an altered regional cerebral metabolic rate of glucose uptake in the anterior hippocampal region correlates with positive and/or negative symptoms of schizophrenia. The effect of two common anti-psychotic agents (remoxipride and haloperidol) on hippocampal glucose metabolism will also be examined. This study will aid in the development of better diagnostic and treatment tools for patients with these and related disorders.

METHODOLOGY

Controls and patients are studied using radiotracer-enhanced positron emission tomography (PET) scans; cognitive challenges may be given during the tracer uptake phase. Patients are tested both on and off medication; the medication status of the subjects is under the direction of their personal physician. Treatment agents are neither administered nor withdrawn as part of this study. A urine sample is obtained before each PET scan to confirm the drug status of the subject. Controls receive one PET scan; patients may recieve up to 4 scans but no more than 2 in any 12 month period.

Subjects are offered water before their PET scan begins. A catheter will be placed in a vein in one arm and another will be placed in an artery or vein of the hand on the other arm. The venous catheter will be used to inject the radiotracer and the arterial (or other venous) catheter will be used to collect blood samples to verify the rate at which the radiotracer is cleared from the blood. After a half-hour uptake phase, subjects are asked to empty their bladder to keep the radiation exposure to the bladder as low as possible. The cognitive challenge, if any, is given during the uptake phase. Subjects are then positioned in the PET scanner, where the technician provides blankets and padding in order to make them as comfortable as possible. Subjects may not move during the scan, which may last 60 to 90 minutes.

IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES

Patients are administered a radiotracer for the purpose of the PET scan. The PET scan entails radiation equivalent to a back x-ray. If an arterial catheter is to be placed, lidocaine is used to provide local anesthesia before placing the catheter.

INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS

PET scan risks include: venous catheter (may cause bruising, faintness); arterial catheter (bruising, pain, faintness, development of blood clot [1%]); radiation (equivalent to back x-ray).


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