NCT00538798

Brief Summary

The metabotropic glutamate subtype five (mGluR5) receptor is a protein found in the brain and is the target for the excitatory chemical messenger glutimate. The purpose of this protocol is to measure mGluR5 receptors in the brain using positron emission tomography (PET) and a research drug called \[18F\]SP203.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 28, 2007

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 2, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 3, 2007

Completed
7.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2015

Completed
Last Updated

July 5, 2018

Status Verified

March 17, 2015

First QC Date

October 2, 2007

Last Update Submit

July 3, 2018

Conditions

Keywords

PharmacokineticsBinding PotentialGlutamatePositron Emission TomographyMetabolic Glutamate ReceptorsHealthy VolunteerHV

Interventions

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy control subjects aged 18 65 years, with history/physical exam, ECG, and laboratory tests within one year of the PET scan within normal limits.

You may not qualify if:

  • Current psychiatric illness, substance abuse or severe systemic disease based on history and physical exam.
  • Laboratory tests with clinically significant abnormalities.
  • Prior participation in other research protocols or clinical care in the last year such that radiation exposure would exceed the annual limits.
  • Pregnancy and breast feeding.
  • Claustrophobia. (part 1 and 3 only)
  • Presence of ferromagnetic metal in the body or heart pacemaker. (part 1 and 3 only)
  • Positive HIV test.
  • Consumed alcohol within 48 hours before the PET scan.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Brodkin J, Bradbury M, Busse C, Warren N, Bristow LJ, Varney MA. Reduced stress-induced hyperthermia in mGluR5 knockout mice. Eur J Neurosci. 2002 Dec;16(11):2241-4. doi: 10.1046/j.1460-9568.2002.02294.x.

    PMID: 12473093BACKGROUND
  • Cosford ND, Roppe J, Tehrani L, Schweiger EJ, Seiders TJ, Chaudary A, Rao S, Varney MA. [3H]-methoxymethyl-MTEP and [3H]-methoxy-PEPy: potent and selective radioligands for the metabotropic glutamate subtype 5 (mGlu5) receptor. Bioorg Med Chem Lett. 2003 Feb 10;13(3):351-4. doi: 10.1016/s0960-894x(02)00997-6.

    PMID: 12565928BACKGROUND
  • Fujita M, Seibyl JP, Verhoeff NP, Ichise M, Baldwin RM, Zoghbi SS, Burger C, Staley JK, Rajeevan N, Charney DS, Innis RB. Kinetic and equilibrium analyses of [(123)I]epidepride binding to striatal and extrastriatal dopamine D(2) receptors. Synapse. 1999 Dec 15;34(4):290-304. doi: 10.1002/(SICI)1098-2396(19991215)34:43.0.CO;2-B.

    PMID: 10529723BACKGROUND

Study Officials

  • Masahiro Fujita, M.D.

    National Institute of Mental Health (NIMH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2007

First Posted

October 3, 2007

Study Start

September 28, 2007

Study Completion

March 17, 2015

Last Updated

July 5, 2018

Record last verified: 2015-03-17

Locations