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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01844726
Other study ID # STU77430
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date May 2013
Est. completion date January 2016

Study information

Verified date March 2023
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 44
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
GLYX-13
Single injection (5 mg/kg) of GLYX-13, an NMDAR partial agonist
Placebo
Single injection of placebo (saline)

Locations

Country Name City State
United States Northwestern University Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. within 1 hour of administration
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