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

NCT ID: NCT01844726

Last Updated: 2023-04-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-01-31

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.

Conditions

Psychiatric Illness; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

GLYX-13

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

Group Type: EXPERIMENTAL

GLYX-13

Intervention Type: DRUG

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

Placebo

Single IV administration of placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single injection of placebo (saline)

Interventions

GLYX-13

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

Intervention Type: DRUG

Placebo

Single injection of placebo (saline)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

James Reilly

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James L Reilly, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU77430

Identifier Type: -

Identifier Source: org_study_id