| Registry | NCT03321617 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; randomized, parallel, masking: triple, treatment |
| Enrollment | 16 (Actual) |
| Sponsor | New York State Psychiatric Institute (Other); collaborators: National Institute of Mental Health (NIMH) |
| Conditions | Clinical High Risk for Psychosis |
| Interventions | Pomaglumetad methionil (Drug) |
| Dates | start 2018-04-17, primary completion 2020-03-13, completion 2020-03-13, first posted 2017-10-25, last updated 2021-12-01 |
| Locations | 1 site in United States |
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All trials for Clinical High Risk for Psychosis All trials of Pomaglumetad methionil
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.
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| POMA 40mg BID (80mg) | Experimental | Drug: Pomaglumetad methionil | Subject will take 40mg pomaglumetad methionil (POMA) twice a day for 14 days. |
| POMA 80mg BID (160 mg) | Experimental | Drug: Pomaglumetad methionil | Subject will take 80 mg pomaglumetad methionil (POMA) twice a day for 14 days |
| POMA 120mg BID (240mg) | Experimental | Drug: Pomaglumetad methionil | Subject will take 120 mg pomaglumetad methionil (POMA) twice a day for 14 days |
| POMA 160 mg BID (320 mg) | Experimental | Drug: Pomaglumetad methionil | Subject will take 160 mg pomaglumetad methionil (POMA) twice a day for 14 days |
Sex: All, ages: 18 Years to 30 Years
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
| Milestone | POMA 40mg BID (80mg) | POMA 80mg BID (160 mg) | POMA 120mg BID (240mg) | POMA 160 mg BID (320 mg) |
|---|---|---|---|---|
| Started | 3 | 3 | 2 | 3 |
| Completed | 2 | 3 | 2 | 2 |
| Not completed | 1 | 0 | 0 | 1 |
Time frame: From consent to 30 days after last dose of study medication, up to 74 days (30-day screening period, 14-day randomization period, 30 day follow up)
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| POMA 40mg BID (80mg) | 0/3 (0.0%) | 0/3 (0.0%) | 1/3 (33.3%) |
| POMA 80mg BID (160 mg) | 0/3 (0.0%) | 0/3 (0.0%) | 3/3 (100.0%) |
| POMA 120mg BID (240mg) | 0/2 (0.0%) | 0/2 (0.0%) | 1/2 (50.0%) |
| POMA 160 mg BID (320 mg) | 0/3 (0.0%) | 0/3 (0.0%) | 2/3 (66.7%) |
| Term | Organ system | POMA 40mg BID (80mg) | POMA 80mg BID (160 mg) | POMA 120mg BID (240mg) | POMA 160 mg BID (320 mg) |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | 1/3 | 2/3 | 1/2 | 2/3 |
| lightheadedness | Nervous system disorders | 0/3 | 0/3 | 0/2 | 1/3 |
| dizziness | Nervous system disorders | 0/3 | 0/3 | 0/2 | 1/3 |
| itching/restlessness | General disorders | 0/3 | 1/3 | 0/2 | 0/3 |
| sedation | Nervous system disorders | 0/3 | 1/3 | 0/2 | 0/3 |
| Facility | City | Country | Status |
|---|---|---|---|
| New York State Psychiatric Institute | New York, New York | United States |
NIH grants: R61MH112800