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Glutamate Reducing Interventions in Schizophrenia

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ClinicalTrials.gov Identifier: NCT03321617
Recruitment Status : Recruiting
First Posted : October 25, 2017
Last Update Posted : August 24, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Scott Small, New York State Psychiatric Institute

Brief Summary:
Participants will be administered several doses of POMA (low and high doses) over 14 days to individuals at clinical high risk for developing psychosis and use MRI brain imaging to determine whether these doses of POMA are affecting glutamate levels.

Condition or disease Intervention/treatment Phase
Clinical High Risk for Psychosis Drug: Pomaglumetad methionil Phase 1

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 CA1 cerebral blood volume (CBV).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind, randomized, phase 1b, multiple dose trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Identity of medications will be blinded having every subject take an equal number of pills (using identical looking tables of placebo)
Primary Purpose: Treatment
Official Title: Glutamate Reducing Interventions in Schizophrenia
Actual Study Start Date : April 17, 2018
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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 Name: 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 Name: 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 Name: 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 Name: POMA; LY2140023




Primary Outcome Measures :
  1. Change in left CA1 CBV from baseline to 14 days [ Time Frame: Baseline to 14 days ]
    Effect of POMA on left CA1 CBV



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03321617


Contacts
Contact: Ragy Girgis, MD 646-774-5553 ragy.girgis@nyspi.columbia.edu
Contact: Marlene Carlson, MPH 646-774-8436 marlene.carlson@nyspi.columbia.edu

Locations
United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Scott Small, MD Columbia University

Responsible Party: Scott Small, Clinical Psychiatrist, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03321617     History of Changes
Other Study ID Numbers: 7459
R61MH112800-01 ( U.S. NIH Grant/Contract )
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders