Glutamate Reducing Interventions in Schizophrenia
| Status: | Recruiting |
|---|---|
| Conditions: | Schizophrenia |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 30 |
| Updated: | 8/26/2018 |
| Start Date: | April 17, 2018 |
| End Date: | September 30, 2022 |
| Contact: | Ragy Girgis, MD |
| Email: | ragy.girgis@nyspi.columbia.edu |
| Phone: | 646-774-5553 |
Participants will be administered several doses of POMA (low and high doses) over 14 days to
individuals at clinical high risk for developing psychosis and use MRI brain imaging to
determine whether these doses of POMA are affecting glutamate levels.
individuals at clinical high risk for developing psychosis and use 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 CA1 cerebral
blood volume (CBV).
(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 CA1 cerebral
blood volume (CBV).
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
We found this trial at
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New York State Psychiatric Institute The New York State Psychiatric Institute (NYSPI), established in 1895,...
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