Glutamate Reducing Interventions in Schizophrenia

New York State Psychiatric Institute

Status and phase: Completed; Phase 1

Conditions: Clinical High Risk for Psychosis

Treatments: Drug: Pomaglumetad methionil

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03321617

7459

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

Details and patient eligibility

About

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.

Full 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).

Enrollment: 16 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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16 participants in 4 patient groups

POMA 40mg BID (80mg)

Experimental group

Description:

Subject will take 40mg pomaglumetad methionil (POMA) twice a day for 14 days.

Treatment:

Drug: Pomaglumetad methionil

POMA 80mg BID (160 mg)

Experimental group

Description:

Subject will take 80 mg pomaglumetad methionil (POMA) twice a day for 14 days

Treatment:

Drug: Pomaglumetad methionil

POMA 120mg BID (240mg)

Experimental group

Description:

Subject will take 120 mg pomaglumetad methionil (POMA) twice a day for 14 days

Treatment:

Drug: Pomaglumetad methionil

POMA 160 mg BID (320 mg)

Experimental group

Description:

Subject will take 160 mg pomaglumetad methionil (POMA) twice a day for 14 days

Treatment:

Drug: Pomaglumetad methionil