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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01844726
First Posted: May 1, 2013
Last Update Posted: January 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
James Reilly, Northwestern University
April 29, 2013
May 1, 2013
January 27, 2016
May 2013
January 2016   (Final data collection date for primary outcome measure)
Enhanced neural activation underlying episodic learning, declarative memory, and working memory performance [ Time Frame: within 1 hour of administration ]
Evidence of enhanced fMRI BOLD signal change during learning, declarative memory, and working memory tasks among individuals receiving GLYX-13 administration compared to those receiving placebo.
Same as current
Complete list of historical versions of study NCT01844726 on ClinicalTrials.gov Archive Site
  • Persistence of enhanced learning, declarative memory, and working memory behavioral performance [ Time Frame: within 1 week of administration ]
    Evidence of persistence of enhanced learning, declarative memory, and working memory behavioral performance among individuals receiving GLYX-13 administration compared to those receiving placebo.
  • Episodic learning, declarative memory, and working memory behavioral performance [ Time Frame: within 1 hour of administration ]
    Evidence of enhanced learning, declarative memory, and working memory performance among individuals receiving GLYX-13 administration compared to those receiving placebo.
Same as current
Not Provided
Not Provided
 
Effects of GLYX-13 on Learning and Memory in Healthy Individuals and Those With Psychiatric Illness
Functional Neuroimaging Effects of the N-methyl-D-aspartate Receptor (NMDAR) Partial Agonist, GLYX-13, on Learning and Memory in Healthy Individuals
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.
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 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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Learning and Memory in Healthy Individuals and Those With Psychiatric Illness
  • Drug: GLYX-13
    Single injection (5 mg/kg) of GLYX-13, an NMDAR partial agonist
  • Drug: Placebo
    Single injection of placebo (saline)
  • Experimental: GLYX-13
    Single IV infusion of GLYX-13, 5mg/kg,
    Intervention: Drug: GLYX-13
  • Placebo Comparator: Placebo
    Single IV administration of placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
January 2016
January 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01844726
STU77430
No
Not Provided
Not Provided
James Reilly, Northwestern University
Northwestern University
Not Provided
Principal Investigator: James L Reilly, PhD Northwestern University
Northwestern University
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP