Glutamate Reducing Interventions in Schizophrenia
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Percent Change in Left Hippocampal CA1 Region Cerebral Blood Volume (CBV) From Baseline to Day 14
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Identity of medications will be blinded having every subject take an equal number of pills (using identical looking tables of placebo)
Eligibility Criteria
- Ages
- 18 Years to 30 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
POMA 40mg BID (80mg)
Subject will take 40mg pomaglumetad methionil (POMA) twice a day for 14 days.
Intervention: Pomaglumetad methionil (Drug)
POMA 80mg BID (160 mg)
Subject will take 80 mg pomaglumetad methionil (POMA) twice a day for 14 days
Intervention: Pomaglumetad methionil (Drug)
POMA 120mg BID (240mg)
Subject will take 120 mg pomaglumetad methionil (POMA) twice a day for 14 days
Intervention: Pomaglumetad methionil (Drug)
POMA 160 mg BID (320 mg)
Subject will take 160 mg pomaglumetad methionil (POMA) twice a day for 14 days
Intervention: Pomaglumetad methionil (Drug)
Outcomes
Primary Outcomes
Percent Change in Left Hippocampal CA1 Region Cerebral Blood Volume (CBV) From Baseline to Day 14
Time Frame: 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)
Secondary Outcomes
No secondary outcomes reported
Investigators
Scott Small
Clinical Psychiatrist
New York State Psychiatric Institute