Clinical High Risk for PsychosisPhase 1NCT03321617
Glutamate Reducing Interventions in Schizophrenia
A Phase 1 study testing Pomaglumetad methionil in people with Clinical High Risk for Psychosis, run by New York State Psychiatric Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Clinical High Risk for Psychosis
- What is being tested?
- Pomaglumetad methionil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2018to 13 Mar 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Capacity to provide informed consent
- Currently using a reliable form of birth control
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
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.
Read the 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).
- Conditions
- Clinical High Risk for Psychosis
- Being tested
- Pomaglumetad methionil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomaglumetad methionilDrug
Also called POMA; LY2140023
metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist
| Study group | Role | What they receive |
|---|---|---|
| POMA 40mg BID (80mg) | Experimental | Subject will take 40mg pomaglumetad methionil (POMA) twice a day for 14 days. Receives: Drug: Pomaglumetad methionil |
| POMA 80mg BID (160 mg) | Experimental | Subject will take 80 mg pomaglumetad methionil (POMA) twice a day for 14 days Receives: Drug: Pomaglumetad methionil |
| POMA 120mg BID (240mg) | Experimental | Subject will take 120 mg pomaglumetad methionil (POMA) twice a day for 14 days Receives: Drug: Pomaglumetad methionil |
| POMA 160 mg BID (320 mg) | Experimental | Subject will take 160 mg pomaglumetad methionil (POMA) twice a day for 14 days Receives: Drug: Pomaglumetad methionil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline to 14 days of POMA/placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start17 Apr 2018
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Clinical High Risk for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomized, phase 1b, multiple dose trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Scott Small, New York State Psychiatric Institute
- Investigators
- Scott Small, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321617
- Sponsor's protocol ID
- 7459
- Other IDs
- R61MH112800-01
- Status last verified
- Nov 2021
- First submitted
- 23 Oct 2017
- Last updated
- 1 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glutamate Reducing Interventions in Schizophrenia
- ClinicalTrials.gov ID
- NCT03321617
- Acronym / sponsor ID
- 7459
- Conditions
- Clinical High Risk for Psychosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 25 Oct 2017 (actual)
- Results
- Posted 1 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Double-blind, randomized, phase 1b, multiple dose trial
| Arm | Type | Receives |
|---|---|---|
| POMA 40mg BID (80mg) | Experimental | Drug: Pomaglumetad methionilSubject will take 40mg pomaglumetad methionil (POMA) twice a day for 14 days. |
| POMA 80mg BID (160 mg) | Experimental | Drug: Pomaglumetad methionilSubject will take 80 mg pomaglumetad methionil (POMA) twice a day for 14 days |
| POMA 120mg BID (240mg) | Experimental | Drug: Pomaglumetad methionilSubject will take 120 mg pomaglumetad methionil (POMA) twice a day for 14 days |
| POMA 160 mg BID (320 mg) | Experimental | Drug: Pomaglumetad methionilSubject will take 160 mg pomaglumetad methionil (POMA) twice a day for 14 days |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Capacity to provide informed consent
- Currently using a reliable form of birth control
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pomaglumetad methionilAlso: POMA; LY2140023metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist | Drug | POMA 120mg BID (240mg), POMA 160 mg BID (320 mg), POMA 40mg BID (80mg), POMA 80mg BID (160 mg) |
Primary outcome
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Small, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pomaglumetad methionil in people with Clinical High Risk for Psychosis, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021.