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Glutamate Reducing Interventions in Schizophrenia

NCT ID: NCT03321617

Last Updated: 2021-12-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-17

Study Completion Date

2020-03-13

Brief Summary

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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

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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

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Clinical High Risk for Psychosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blind, randomized, phase 1b, multiple dose trial
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Identity of medications will be blinded having every subject take an equal number of pills (using identical looking tables of placebo)

Study Groups

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POMA 40mg BID (80mg)

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

Group Type EXPERIMENTAL

Pomaglumetad methionil

Intervention Type DRUG

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

POMA 80mg BID (160 mg)

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

Group Type EXPERIMENTAL

Pomaglumetad methionil

Intervention Type DRUG

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

POMA 120mg BID (240mg)

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

Group Type EXPERIMENTAL

Pomaglumetad methionil

Intervention Type DRUG

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

POMA 160 mg BID (320 mg)

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

Group Type EXPERIMENTAL

Pomaglumetad methionil

Intervention Type DRUG

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

Interventions

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Pomaglumetad methionil

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

Intervention Type DRUG

Other Intervention Names

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POMA; LY2140023

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

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Scott Small

Clinical Psychiatrist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Scott Small, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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New York State Psychiatric Institute

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R61MH112800-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

7459

Identifier Type: -

Identifier Source: org_study_id