Glutamate Reducing Interventions in Schizophrenia

Clinical High Risk for Psychosis Clinical Trial

Official title:

Glutamate Reducing Interventions in Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03321617
• Other study ID #: 7459
• Secondary ID: R61MH112800-01
• Status: Completed
• Phase: Phase 1
• Start date: April 17, 2018
• Est. completion date: March 13, 2020

Study information

• Verified date: November 2021
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 13, 2020
• Est. primary completion date: March 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Clinical High Risk for Psychosis
• Schizophrenia

Intervention

Drug:
• Pomaglumetad methionil
metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Left Hippocampal CA1 Region Cerebral Blood Volume (CBV) From Baseline to Day 14	Effect of POMA on left CA1 CBV as measured by percent change from baseline scan (Time 1) to Day 14 scan (Time 2)	Baseline to 14 days of POMA/placebo