Biomarker Assessment of Glutamatergic Target Engagement
Condition: Healthy Controls
Intervention: Ketamine; Normal saline
Intervention description: intravenous infusion of saline solution with ketamine; Normal saline will be used for placebo in this group
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to assess the relative feasibility of 2 potential functional
      measures of target engagement (Glx MRS, BOLD fMRI) to systematically assess mGluR 2/3 in drug
      development for psychotic spectrum disorders.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-55

          -  Negative Urine Toxicology

          -  No present or past psychiatric conditions (including substance abuse or dependence,
             with the exception of nicotine dependence)

          -  No family history of schizophrenia in a first-degree relative

        Exclusion Criteria:

          -  Any current DSM IV Axis I disorder and/or past substance abuse of dependence (nicotine
             dependence is allowed)

          -  Any current use of amphetamines, opiates, cocaine, sedative-hypnotics, or cannabis

          -  Current (i.e., within the last 3 months) treatment with any psychotropic medications

          -  Pregnancy, lactation, or lack of use of effective birth control

          -  Presence of positive history of significant medical or neurological illness (including
             any history of seizure), including high blood pressure (SBP >140, DBP >90), low blood
             pressure (SBP <100, DBP <60), orthostatic BP change>20% (1/3 SBP + 2/3 DBP) or cardiac
             illness or resting heart rate >100 or <50

          -  History of significant violent behavior

          -  History of recreational ketamine use, recreational PCP use, or an adverse reaction to
             ketamine. Subjects who have participated prior research ketamine studies will be
             eligible providing they have participated in no more than 5 previous research ketamine
             infusions. Subjects can have infusions not more frequently than biweekly and not more
             than 1/month on average, therefore subjects entering the study will need to wait 1
             month if they had a single infusion and 6 weeks if they have had two closely spaced
             infusions.

          -  Contraindication to MRI scanning, including metal implants or claustrophobia. Metal
             implants, pacemaker, other metal (e.g. shrapnel or surgical prostheses) or
             paramagnetic objects contained within the body which may present a risk to the subject
             or interfere with the MR scan, as determined in consultation with a neuroradiologist
             and according to the guidelines set forth in the following reference book commonly
             used by neuroradiologists: "Guide to MR procedures and metallic objects", F.G.
             Shellock, Lippincott Williams and Wilkins NY 2001

          -  Color Blindness