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Effects of GLYX-13 on Learning and Memory in Healthy Individuals and Those With Psychiatric Illness

Primary Purpose

Psychiatric Illness, Healthy

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GLYX-13
Placebo
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychiatric Illness focused on measuring healthy individuals, schizophrenia, schizoaffective disorder, learning, memory, cognitive enhancement, fMRI

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

For all Individuals

  • Male and female subjects
  • Ages 18 - 40 years
  • General intellectual abilities falling broadly within the average range (estimated IQ between 80 - 119)
  • Sufficient ability to understand study requirements and provide written informed consent

For Patients

-Diagnosis of Schizophrenia or Schizoaffective Disorder

Exclusion Criteria:

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, PCP, 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 SCID criteria
  • History of treatment with antidepressant, antipsychotic, stimulant,sedative/ hypnotic, mood stabilizing, or anticholinergic medications or lithium
  • History among first-degree family members of any psychotic illness or major mood disorder (e.g., major depressive disorder, recurrent; bipolar I or II disorder)

For Patients

  • Treatment with Clozaril
  • Change in medication within 1 month
  • Hospitalization within 1 month

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GLYX-13

Placebo

Arm Description

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

Single IV administration of placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Category Learning Behavioral Performance
This measure reflects the percentage of correct trials on a category learning task in which subjects learned the category membership (group A or group B) of 8 three-digit numbers presented over 64 trials. Higher values (>50%) reflect increased accuracy in learning the category membership.

Full Information

First Posted
April 29, 2013
Last Updated
March 31, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT01844726
Brief Title
Effects of GLYX-13 on Learning and Memory in Healthy Individuals and Those With Psychiatric Illness
Official Title
Functional Neuroimaging Effects of the N-methyl-D-aspartate Receptor (NMDAR) Partial Agonist, GLYX-13, on Learning and Memory in Healthy Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Study sponsor was acquired by another company.
Study Start Date
May 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
In a single blind randomized parallel group design, we will evaluate the whether a single dose of GLYX-13 vs. placebo increases cognitive performance on tasks of learning, declarative memory, and working memory, and associated task-related increases in blood oxygen level-dependent (BOLD) activation in hippocampus and dorsolateral prefrontal cortex, respectively. Positive findings will provide biomarker evidence for GLYX-13 effects on neural systems underlying these cognitive processes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychiatric Illness, Healthy
Keywords
healthy individuals, schizophrenia, schizoaffective disorder, learning, memory, cognitive enhancement, fMRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GLYX-13
Arm Type
Experimental
Arm Description
Single IV infusion of GLYX-13, 5mg/kg,
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single IV administration of placebo
Intervention Type
Drug
Intervention Name(s)
GLYX-13
Intervention Description
Single injection (5 mg/kg) of GLYX-13, an NMDAR partial agonist
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single injection of placebo (saline)
Primary Outcome Measure Information:
Title
Percentage of Change in fMRI BOLD Signal During a Category Learning Task
Description
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.
Time Frame
within 1 hour of administration
Secondary Outcome Measure Information:
Title
Category Learning Behavioral Performance
Description
This measure reflects the percentage of correct trials on a category learning task in which subjects learned the category membership (group A or group B) of 8 three-digit numbers presented over 64 trials. Higher values (>50%) reflect increased accuracy in learning the category membership.
Time Frame
within 1 hour of administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 History among first-degree family members of any psychotic illness or major mood disorder (e.g., major depressive disorder, recurrent; bipolar I or II disorder) For Patients Treatment with Clozaril Change in medication within 1 month Hospitalization within 1 month
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James L Reilly, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

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Effects of GLYX-13 on Learning and Memory in Healthy Individuals and Those With Psychiatric Illness

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