Depression Clinical Trial
Official title:
PET Brain and Whole Body Distribution Studies for Nociceptin/Orphanin FQ Peptide (NOP) Receptor Using [(11)C]NOP-1A
Verified date | September 5, 2014 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background:
- A small brain protein called nociceptin/orphanin FQ peptide (NOP) receptor may be involved
in several brain diseases such as anxiety, depression, drug abuse, and seizures. Researchers
are interested in testing a new radioactive chemical that will help locate NOP receptors in
the brain during imaging studies such as positron emission tomography (PET) scans. Because
this chemical has not yet been approved by the Food and Drug Administration, it is considered
to be an experimental drug.
Objectives:
- To investigate the effectiveness of the experimental chemical [11C]NOP-1A in imaging
studies of the nociceptin/orphanin FQ peptide (NOP) receptor.
Eligibility:
- Healthy volunteers between 18 and 50 years of age who are able to have imaging studies.
Design:
- This study will involve three or four outpatient visits to the National Institutes of
Health Clinical Center. All participants will be screened with a full physical
examination, medical history, blood and urine tests, and electrocardiogram.
- Participants will be involved in one or more parts of this three-part study as directed
by study researchers. Part 1 consists of brain imaging to study how the brain responds
to the chemical. Part 2 is a whole body imaging study to evaluate how the chemical is
distributed throughout the body after being administered. Part 3 is a set of testing and
retesting scans to determine how precise the drug is in locating the NOP receptors in
the brain.
- Part 1: Participants will have a brain magnetic resonance imaging (MRI) scan. Then the
study drug will be administered and participants will have a brain PET scan. Blood
samples will be taken during the PET scan, and urine samples will be taken after the
scan. These tests will take up to 3 hours to perform.
- Part 2: Participants will have a whole body PET scan that will last a maximum of 3
hours.
- Part 3: Participants will receive the study drug and have two additional PET scans.
Blood samples will also be taken during this part.
Status | Completed |
Enrollment | 41 |
Est. completion date | February 28, 2014 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
- INCLUSION CRITERIA: Healthy Volunteers: Subjects must be adults between 18-50 years old. Subjects must be able and willing to give written informed consent. EXCLUSION CRITERIA: Current psychiatric illness or severe systemic disease based on history and physical exam. If women, pregnancy or breast feeding (betaHCG will be measured in all female patients within 24 hours of scan and must be negative) Clinically significant laboratory abnormalities. Serious medical problems including but not limited to chronic neurological disease such as multiple sclerosis, autoimmune diseases or any cardiopulmonary disease. Head trauma resulting in a period of unconsciousness lasting longer than 10 minutes. Recent exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits. Positive urine drug screen at screening. Inability to lie flat on camera bed for about 2.5 hours Subjects who have metallic foreign bodies that would be affected by the MRI magnet, or fear of enclosed spaces likely to make the subject unable to undergo an MRI scan. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Mental Health (NIMH) |
United States,
Berthele A, Platzer S, Dworzak D, Schadrack J, Mahal B, Büttner A, Assmus HP, Wurster K, Zieglgänsberger W, Conrad B, Tölle TR. [3H]-nociceptin ligand-binding and nociceptin opioid receptor mrna expression in the human brain. Neuroscience. 2003;121(3):629-40. — View Citation
Bridge KE, Wainwright A, Reilly K, Oliver KR. Autoradiographic localization of (125)i[Tyr(14)] nociceptin/orphanin FQ binding sites in macaque primate CNS. Neuroscience. 2003;118(2):513-23. — View Citation
Brown AK, Fujita M, Fujimura Y, Liow JS, Stabin M, Ryu YH, Imaizumi M, Hong J, Pike VW, Innis RB. Radiation dosimetry and biodistribution in monkey and man of 11C-PBR28: a PET radioligand to image inflammation. J Nucl Med. 2007 Dec;48(12):2072-9. Epub 2007 Nov 15. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | For the PET scans, we will measure the regional densities of NOP receptors as distribution volume (VT). Distribution volume is the ratio at equilibrium of brain uptake to the concentration of parent radioligand in plasma. | 2 years |
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