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Pomaglumetad Effects on Glutamate Biomarkers

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ClinicalTrials.gov Identifier: NCT02919774
Recruitment Status : Completed
First Posted : September 29, 2016
Last Update Posted : September 12, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Marlene Carlson, New York State Psychiatric Institute

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).

Condition or disease Intervention/treatment Phase
Healthy Controls Drug: POMA Drug: placebo Phase 1

Detailed Description:
This study evaluates the effects of POMA at selected doses on ketamine-stimulated glutamate increase in the prefrontal cortex hypothesized to simulate the synaptic dysregulation that occurs endogenously in the pathogenesis of schizophrenia. The purpose of this is: 1) to determine whether the low dose (40 mg BID) utilized in recent (failed) clinical trials is sufficient to engage the primary target and 2) whether a higher (160 mg BID) dose, representing the maximum tolerated dose of POMA, engages the target to a greater degree. This study will further validate pharmacoBOLD as biomarker of mGluR2/3 target engagement, permitting its future use in other glutamatergic drug development.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Biomarker Assessment of Pomaglumetad on Glutamate Targets: Proof of Clinical Mechanism of Action (POCM)
Actual Study Start Date : October 2016
Actual Primary Completion Date : April 28, 2018
Actual Study Completion Date : May 25, 2018

Arm Intervention/treatment
Experimental: POMA 40 mg BID
40 mg BID for 10 days
Drug: POMA
Pomaglumetad ("POMA") is a mGluR 2/3 partial agonist
Other Name: Pomaglumetad

Experimental: POMA 160 mg BID
160 mg BID for 10 days
Drug: POMA
Pomaglumetad ("POMA") is a mGluR 2/3 partial agonist
Other Name: Pomaglumetad

Placebo Comparator: Placebo
Placebo BID for 10 days
Drug: placebo
matching placebo tablets
Other Name: placebo comparator




Primary Outcome Measures :
  1. PharmacoBOLD change [ Time Frame: Day 1 to Day 10 ]
    pharmacoBOLD change, as summarized by the Amplitude measure


Secondary Outcome Measures :
  1. Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Day 1 to Day 10 ]
    Clinical rating scale assessing common psychiatric symptoms

  2. Clinician Administered Dissociative States Scale (CADSS) [ Time Frame: Day 1 to Day 10 ]
    Rates dissociative symptoms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02919774


Locations
United States, Alabama
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35233
United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
United States, New York
New York University
New York, New York, United States, 10016
Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Jeffrey A Lieberman, MD New York State Psychiatric Institute

Responsible Party: Marlene Carlson, Study Manager, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02919774     History of Changes
Other Study ID Numbers: 7285
271201200007I-4-27100003-2 ( U.S. NIH Grant/Contract )
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Submit to NDCT