Glutamate Reducing Interventions in Schizophrenia

November 5, 2021 updated by: Scott Small, New York State Psychiatric Institute
Participants will be administered several doses of pomaglumetad (POMA) (low and high doses) over 14 days to individuals at clinical high risk for developing psychosis and use magnetic resonance imaging (MRI) brain imaging to determine whether these doses of POMA are affecting glutamate levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A double-blind, randomized, phase 1b, multiple dose trial of 14 days of treatment with POMA (80 mg, 160 mg, 240 mg, 320 mg) in clinical high risk patients to determine which dose, if any, reduces glutamate and metabolism using MRI techniques. The GO NO-GO decision will be whether or not any dose tested in the R61 phase of the trial decreases left hippocampal CA1 region cerebral blood volume (CBV).

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Capacity to provide informed consent
  • Currently using a reliable form of birth control

Exclusion Criteria:

  • Metal implants in body or a history of metal working
  • Lifetime diagnosis of asthmatic symptoms within the past 3 years or known sensitivity to contrast agents
  • Lifetime diagnosis of renal failure/disease
  • Acute neurological, neuroendocrine, or medical disorder including renal insufficiency (CrCl<40 mL/min/1.73m2)
  • Lifetime diagnosis of hypertension or diabetes or seizure disorder
  • IQ<70
  • Acute risk for suicide and/or violence
  • Pregnant lactating
  • Current abuse of substances (alcohol, cocaine, stimulants, cannabis, opiates, sedative hypnotics)
  • Current use or anticipated need for antipsychotics or mood stabilizers (all antipsychotics, also depakote, lithium, lamotrogine, pregabalin or any med with a mechanism of action like gabapentin), probenecid, selective serotonin reuptake inhibitors, tricyclic antidepressants, and monoamine oxidase inhibitors
  • More than one previous gadolinium scan

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: POMA 40mg BID (80mg)
Subject will take 40mg pomaglumetad methionil (POMA) twice a day for 14 days.
Drug: Pomaglumetad methionil
metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist
Other Names:
  • POMA; LY2140023
Experimental: POMA 80mg BID (160 mg)
Subject will take 80 mg pomaglumetad methionil (POMA) twice a day for 14 days
Drug: Pomaglumetad methionil
metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist
Other Names:
  • POMA; LY2140023
Experimental: POMA 120mg BID (240mg)
Subject will take 120 mg pomaglumetad methionil (POMA) twice a day for 14 days
Drug: Pomaglumetad methionil
metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist
Other Names:
  • POMA; LY2140023
Experimental: POMA 160 mg BID (320 mg)
Subject will take 160 mg pomaglumetad methionil (POMA) twice a day for 14 days
Drug: Pomaglumetad methionil
metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist
Other Names:
  • POMA; LY2140023

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in Left Hippocampal CA1 Region Cerebral Blood Volume (CBV) From Baseline to Day 14
Time Frame: Baseline to 14 days of POMA/placebo
Effect of POMA on left CA1 CBV as measured by percent change from baseline scan (Time 1) to Day 14 scan (Time 2)
Baseline to 14 days of POMA/placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Scott Small, MD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2018

Primary Completion (Actual)

March 13, 2020

Study Completion (Actual)

March 13, 2020

Study Registration Dates

First Submitted

October 23, 2017

First Submitted That Met QC Criteria

October 23, 2017

First Posted (Actual)

October 25, 2017

Study Record Updates

Last Update Posted (Actual)

December 1, 2021

Last Update Submitted That Met QC Criteria

November 5, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7459
  • R61MH112800-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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