NCT02919774

Brief Summary

The study will evaluate the effects of the mGluR2/3 partial agonist LY2140023 (Pomaglumetad Methionil, "POMA") at selected doses on ketamine-stimulated glutamate release in prefrontal cortex as measured by pharmacoBOLD fMRI (also termed resting BOLD fMRI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

4 active sites

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

September 26, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2018

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2018

Completed
Last Updated

September 12, 2018

Status Verified

September 1, 2018

Enrollment Period

1.6 years

First QC Date

September 26, 2016

Last Update Submit

September 10, 2018

Conditions

Healthy Controls

Outcome Measures

Primary Outcomes (1)

  • PharmacoBOLD change

    pharmacoBOLD change, as summarized by the Amplitude measure

    Day 1 to Day 10

Secondary Outcomes (2)

  • Brief Psychiatric Rating Scale (BPRS)

    Day 1 to Day 10

  • Clinician Administered Dissociative States Scale (CADSS)

    Day 1 to Day 10

Study Arms (3)

POMA 40 mg BID

EXPERIMENTAL

40 mg BID for 10 days

Drug: POMA

POMA 160 mg BID

EXPERIMENTAL

160 mg BID for 10 days

Drug: POMA

Placebo

PLACEBO COMPARATOR

Placebo BID for 10 days

Drug: placebo

Interventions

POMADRUG

Pomaglumetad ("POMA") is a mGluR 2/3 partial agonist

Also known as: Pomaglumetad
POMA 160 mg BIDPOMA 40 mg BID
placeboDRUG

matching placebo tablets

Also known as: placebo comparator
Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Medically healthy
  • Capable of understanding the study procedures and able to provide informed consent
  • Men and women must agree to use a reliable method of birth control during the study. Women who are post-menopausal or otherwise not of childbearing potential are also eligible

You may not qualify if:

  • Current or past Axis I psychiatric history
  • Positive urine toxicology
  • History of recreational ketamine use, recreational PCP use, or an adverse reaction to ketamine. Subjects who have participated in prior research ketamine studies will be eligible. Subjects can have infusions not more frequently than biweekly, and not more than 1/month on average, therefore subjects entering the study will need to wait one month if they had a single infusion and 6 weeks if they have had two closely spaced infusions.
  • History of first-degree relative with schizophrenia
  • History of violence
  • Presence or positive history of significant medical illness
  • Presence or positive history neurological illness or any other disease/procedure/accident/intervention association with significant injury to or malfunction of the central nervous system (CNS) or history of significant head injury
  • Pregnancy or breast feeding
  • Metal implants, pacemaker, other metal or paramagnetic objects contained within the body
  • Medicinal patch, unless removed prior to MRI scan
  • Currently taking any psychotropic medication, including antidepressant medications, benzodiazepines, antipsychotic medications, mood stabilizers, anti-epileptic medications and stimulants.
  • Claustrophobia
  • Suicidal ideation with intent or plan in the 6 months prior to screening
  • Weight \> 86.95 kg (191.2 lbs)
  • Subthreshold pharmacoBOLD response during screening ketamine infusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Alabama, Birmingham

Birmingham, Alabama, 35233, United States

Location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

New York University

New York, New York, 10016, United States

Location

Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Interventions

poly(n-octyl methacrylate)pomaglumetad methionil

Study Officials

  • Jeffrey A Lieberman, MD

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Manager

Study Record Dates

First Submitted

September 26, 2016

First Posted

September 29, 2016

Study Start

October 1, 2016

Primary Completion

April 28, 2018

Study Completion

May 25, 2018

Last Updated

September 12, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will share

Submit to NDCT

Locations

US(4)