Pomaglumetad Effects on Glutamate Biomarkers

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Controls

In brief

The study will evaluate the effects of the mGluR2/3 partial agonist LY2140023 (Pomaglumetad Methionil, "POMA") at selected doses on ketamine-stimulated glutamate release in prefrontal cortex as measured by pharmacoBOLD fMRI (also termed resting BOLD fMRI).

Key facts

Study ID

NCT02919774

Run by

New York State Psychiatric Institute

People needed

95

Starts

2016-10-01

Expected to finish

2018-05-25

Last updated by the study team

2018-09-12

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Medically healthy
• Capable of understanding the study procedures and able to provide informed consent
• Men and women must agree to use a reliable method of birth control during the study. Women who are post-menopausal or otherwise not of childbearing potential are also eligible

You may not qualify if…

• Current or past Axis I psychiatric history
• Positive urine toxicology
• History of recreational ketamine use, recreational PCP use, or an adverse reaction to ketamine. Subjects who have participated in prior research ketamine studies will be eligible. 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 one month if they had a single infusion and 6 weeks if they have had two closely spaced infusions.
• History of first-degree relative with schizophrenia
• History of violence
• Presence or positive history of significant medical illness
• Presence or positive history neurological illness or any other disease/procedure/accident/intervention association with significant injury to or malfunction of the central nervous system (CNS) or history of significant head injury
• Pregnancy or breast feeding
• Metal implants, pacemaker, other metal or paramagnetic objects contained within the body
• Medicinal patch, unless removed prior to MRI scan
• Currently taking any psychotropic medication, including antidepressant medications, benzodiazepines, antipsychotic medications, mood stabilizers, anti-epileptic medications and stimulants.
• Claustrophobia
• Suicidal ideation with intent or plan in the 6 months prior to screening
• Weight > 86.95 kg (191.2 lbs)
• Subthreshold pharmacoBOLD response during screening ketamine infusion

Where it is running

• University of Alabama, Birmingham — Birmingham, Alabama, United States
• University of California, Los Angeles — Los Angeles, California, United States
• New York University — New York, New York, United States
• Columbia University — New York, New York, United States

Full record on ClinicalTrials.gov

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