Phase 1
Completed N=11
Glutamate Reducing Interventions in Schizophrenia
Source: ClinicalTrials.gov NCT03321617 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcomePrimary: Percent Change in Left Hippocampal CA1 Region Cerebral Blood Volume (CBV) From Baseline to Day 14 — 0.40684405; -0.081559; 0.0219668; -0.0269017 Percent change
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Left Hippocampal CA1 Region Cerebral Blood Volume (CBV) From Baseline to Day 14 |
0.40684405; -0.081559; 0.0219668; -0.0269017 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03321617). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.