NCT03321617

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

April 17, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2020

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

December 1, 2021

Completed
Last Updated

December 1, 2021

Status Verified

November 1, 2021

Enrollment Period

1.9 years

First QC Date

October 23, 2017

Results QC Date

September 2, 2021

Last Update Submit

November 5, 2021

Conditions

Clinical High Risk for Psychosis

Outcome Measures

Primary Outcomes (1)

  • 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)

    Baseline to 14 days of POMA/placebo

Study Arms (4)

POMA 40mg BID (80mg)

EXPERIMENTAL

Subject will take 40mg pomaglumetad methionil (POMA) twice a day for 14 days.

Drug: Pomaglumetad methionil

POMA 80mg BID (160 mg)

EXPERIMENTAL

Subject will take 80 mg pomaglumetad methionil (POMA) twice a day for 14 days

Drug: Pomaglumetad methionil

POMA 120mg BID (240mg)

EXPERIMENTAL

Subject will take 120 mg pomaglumetad methionil (POMA) twice a day for 14 days

Drug: Pomaglumetad methionil

POMA 160 mg BID (320 mg)

EXPERIMENTAL

Subject will take 160 mg pomaglumetad methionil (POMA) twice a day for 14 days

Drug: Pomaglumetad methionil

Interventions

Pomaglumetad methionilDRUG

metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist

Also known as: POMA; LY2140023
POMA 120mg BID (240mg)POMA 160 mg BID (320 mg)POMA 40mg BID (80mg)POMA 80mg BID (160 mg)

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Capacity to provide informed consent
  • Currently using a reliable form of birth control

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Interventions

pomaglumetad methionilpoly(n-octyl methacrylate)LY 2140023

Results Point of Contact

Title
Ragy Girgis, MD
Organization
New York State Psychiatric Institute
ragy.girgis@nyspi.columbia.edu
646-774-5553

Study Officials

  • Scott Small, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Identity of medications will be blinded having every subject take an equal number of pills (using identical looking tables of placebo)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double-blind, randomized, phase 1b, multiple dose trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Psychiatrist

Study Record Dates

First Submitted

October 23, 2017

First Posted

October 25, 2017

Study Start

April 17, 2018

Primary Completion

March 13, 2020

Study Completion

March 13, 2020

Last Updated

December 1, 2021

Results First Posted

December 1, 2021

Record last verified: 2021-11

Locations

US(1)