Glutamate Reducing Interventions in Schizophrenia

Phase 1

Completed

• Conditions: Clinical High Risk for Psychosis
• Interventions: Drug: Pomaglumetad methionil

• Registration Number: NCT03321617
• Lead Sponsor: New York State Psychiatric Institute

Brief 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).

Study Timeline

• Study First Submitted: 2017-10-23
• Study First Submitted QC: 2017-10-23
• Study First Posted: 2017-10-25
• Study Start: 2018-04-17
• Primary Completion: 2020-03-13
• Study Completion: 2020-03-13
• Results First Submitted: 2021-09-02
• Status Verified: 2021-11
• Results First Submitted QC: 2021-11-05
• Last Update Submitted: 2021-11-05
• Results First Posted: 2021-12-01
• Last Update Posted: 2021-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
POMA 40mg BID (80mg)	Pomaglumetad methionil	Subject will take 40mg pomaglumetad methionil (POMA) twice a day for 14 days.
POMA 80mg BID (160 mg)	Pomaglumetad methionil	Subject will take 80 mg pomaglumetad methionil (POMA) twice a day for 14 days
POMA 120mg BID (240mg)	Pomaglumetad methionil	Subject will take 120 mg pomaglumetad methionil (POMA) twice a day for 14 days
POMA 160 mg BID (320 mg)	Pomaglumetad methionil	Subject will take 160 mg pomaglumetad methionil (POMA) twice a day for 14 days

Primary Outcome Measures

Name	Time	Method
Percent Change in Left Hippocampal CA1 Region Cerebral Blood Volume (CBV) From Baseline to Day 14	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)

Trial Locations

Locations (1)

New York State Psychiatric Institute; 🇺🇸 New York, New York, United States