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OpenTrials
Completed

NCT Number: NCT03321617

Glutamate Reducing Interventions in Schizophrenia

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.

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Key information

Conditions

Clinical High Risk for Psychosis

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New York State Psychiatric Institute

New York, 10032, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pomaglumetad methionil

Drug

metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist

Other names: POMA; LY2140023

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 25, 2017
Registry last updated
Dec 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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