NCT01844726

Brief Summary

The present study proposes to evaluate the potential cognitive enhancing effects of GLYX-13, an NMDAR partial agonist, among a group of healthy adults and those with psychiatric illness on a series of functional magnetic resonance imaging (fMRI) learning and memory tasks.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
terminated

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

April 29, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
7.3 years until next milestone

Results Posted

Study results publicly available

April 20, 2023

Completed
Last Updated

April 20, 2023

Status Verified

March 1, 2023

Enrollment Period

2.7 years

First QC Date

April 29, 2013

Results QC Date

February 25, 2023

Last Update Submit

March 31, 2023

Conditions

Psychiatric IllnessHealthy

Keywords

healthy individualsschizophreniaschizoaffective disorderlearningmemorycognitive enhancementfMRI

Outcome Measures

Primary Outcomes (1)

  • Percentage of Change in fMRI BOLD Signal During a Category Learning Task

    Evidence of enhanced functional magnetic resonance imaging (fMRI) blood oxygen level-dependent (BOLD) signal change during a category learning task among individuals receiving GLYX-13 administration compared to those receiving placebo. Value represents fMRI BOLD signal change (in % change) across a task derived functional network. Higher scores indicate greater task-based activation across this functional circuit.

    within 1 hour of administration

Secondary Outcomes (1)

  • Category Learning Behavioral Performance

    within 1 hour of administration

Study Arms (2)

GLYX-13

EXPERIMENTAL

Single IV infusion of GLYX-13, 5mg/kg,

Drug: GLYX-13

Placebo

PLACEBO COMPARATOR

Single IV administration of placebo

Drug: Placebo

Interventions

GLYX-13DRUG

Single injection (5 mg/kg) of GLYX-13, an NMDAR partial agonist

GLYX-13
PlaceboDRUG

Single injection of placebo (saline)

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • For all Individuals
  • Male and female subjects
  • Ages 18 - 40 years
  • General intellectual abilities falling broadly within the average range (estimated intelligence quotient (IQ) between 80 - 119)
  • Sufficient ability to understand study requirements and provide written informed consent
  • For Patients
  • Diagnosis of Schizophrenia or Schizoaffective Disorder

You may not qualify if:

  • For all individuals:
  • History of neurologic disorder or systemic medical condition that may interfere with central nervous system function
  • History of seizures
  • History of heard injury with loss of consciousness or concussion
  • Positive screen for drugs of abuse: cocaine, marijuana, phencyclidine, ketamine, opioid, or other agent that is being abused in the opinion of the investigator
  • Females who are currently pregnant or plan to become pregnant during the study period
  • History of allergy, sensitivity, or intolerance to N-methyl-D-Aspartate receptor (NMDAR) ligands including ketamine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone
  • History of any ferromagnetic object in the body
  • Presence of any medical device or implant for which MRI is contraindicated including cardiac pacemaker, aneurysm clip, cochlear implant, copper intrauterine device (IUD), neurostimulator, or any other device deemed unsafe
  • Bullet or shrapnel in body
  • Metallic braces or permanent retainer
  • Significant claustrophobia
  • For Healthy Individuals
  • Personal history of any Axis I disorder according to the Structured Clinical Interview for the DSM-5 (SCID-5) criteria
  • History of treatment with antidepressant, antipsychotic, stimulant,sedative/ hypnotic, mood stabilizing, or anticholinergic medications or lithium
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Mental DisordersSchizophreniaPsychotic Disorders

Interventions

GLYX-13 peptide

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Results Point of Contact

Title
Dr. James Reilly
Organization
Northwestern University
james.reilly@northwestern.edu
312-503-4809

Study Officials

  • James L Reilly, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 29, 2013

First Posted

May 1, 2013

Study Start

May 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

April 20, 2023

Results First Posted

April 20, 2023

Record last verified: 2023-03

Locations

US(1)