Pomaglumetad Effects on Glutamate Biomarkers

• Status: Completed
• Trial end date: 2018-05-25
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: National Institute of Mental Health (NIMH)

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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