Clinical trial NCT01844726: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Psychiatric Illness
Healthy
Keywords: healthy individuals
schizophrenia
schizoaffective disorder
learning
memory
cognitive enhancement
fMRI
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2013-05-01
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Change in fMRI BOLD Signal During a Category Learning Task
timeFrame: within 1 hour of administration
Secondary outcomes:
measure: Category Learning Behavioral Performance
timeFrame: within 1 hour of administration
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: James L Reilly, PhD
role: PRINCIPAL_INVESTIGATOR
References: