NCT03321617

Glutamate Reducing Interventions in Schizophrenia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

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.

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).

Conditions

• Clinical High Risk for Psychosis

Interventions

Type	Name	Description
DRUG	Pomaglumetad methionil	metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist

Timeline

• Start date: 2018-04-17
• Primary completion: 2020-03-13
• Completion: 2020-03-13
• First posted: 2017-10-25
• Last updated: 2021-12-01
• Results posted: 2021-12-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study