Glutamate Reducing Interventions in Schizophrenia
Primary Purpose
Clinical High Risk for Psychosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pomaglumetad methionil
Sponsored by
About this trial
This is an interventional treatment trial for Clinical High Risk for Psychosis
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
Sites / Locations
- New York State Psychiatric Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
POMA 40mg BID (80mg)
POMA 80mg BID (160 mg)
POMA 120mg BID (240mg)
POMA 160 mg BID (320 mg)
Arm Description
Subject will take 40mg pomaglumetad methionil (POMA) twice a day for 14 days.
Subject will take 80 mg pomaglumetad methionil (POMA) twice a day for 14 days
Subject will take 120 mg pomaglumetad methionil (POMA) twice a day for 14 days
Subject will take 160 mg pomaglumetad methionil (POMA) twice a day for 14 days
Outcomes
Primary Outcome Measures
Percent Change in Left Hippocampal CA1 Region Cerebral Blood Volume (CBV) From Baseline to Day 14
Effect of POMA on left CA1 CBV as measured by percent change from baseline scan (Time 1) to Day 14 scan (Time 2)
Secondary Outcome Measures
Full Information
NCT ID
NCT03321617
First Posted
October 23, 2017
Last Updated
November 5, 2021
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT03321617
Brief Title
Glutamate Reducing Interventions in Schizophrenia
Official Title
Glutamate Reducing Interventions in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 17, 2018 (Actual)
Primary Completion Date
March 13, 2020 (Actual)
Study Completion Date
March 13, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clinical High Risk for Psychosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Double-blind, randomized, phase 1b, multiple dose trial
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Identity of medications will be blinded having every subject take an equal number of pills (using identical looking tables of placebo)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
POMA 40mg BID (80mg)
Arm Type
Experimental
Arm Description
Subject will take 40mg pomaglumetad methionil (POMA) twice a day for 14 days.
Arm Title
POMA 80mg BID (160 mg)
Arm Type
Experimental
Arm Description
Subject will take 80 mg pomaglumetad methionil (POMA) twice a day for 14 days
Arm Title
POMA 120mg BID (240mg)
Arm Type
Experimental
Arm Description
Subject will take 120 mg pomaglumetad methionil (POMA) twice a day for 14 days
Arm Title
POMA 160 mg BID (320 mg)
Arm Type
Experimental
Arm Description
Subject will take 160 mg pomaglumetad methionil (POMA) twice a day for 14 days
Intervention Type
Drug
Intervention Name(s)
Pomaglumetad methionil
Other Intervention Name(s)
POMA; LY2140023
Intervention Description
metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist
Primary Outcome Measure Information:
Title
Percent Change in Left Hippocampal CA1 Region Cerebral Blood Volume (CBV) From Baseline to Day 14
Description
Effect of POMA on left CA1 CBV as measured by percent change from baseline scan (Time 1) to Day 14 scan (Time 2)
Time Frame
Baseline to 14 days of POMA/placebo
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Small, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Glutamate Reducing Interventions in Schizophrenia
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