Status:
COMPLETED
Glutamate Reducing Interventions in Schizophrenia
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Clinical High Risk for Psychosis
Eligibility:
All Genders
18-30 years
Phase:
PHASE1
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 imagin...
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 glut...
Eligibility Criteria
Inclusion
- Capacity to provide informed consent
- Currently using a reliable form of birth control
Exclusion
- 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
Key Trial Info
Start Date :
April 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2020
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03321617
Start Date
April 17 2018
End Date
March 13 2020
Last Update
December 1 2021
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032