Effects of GLYX-13 on Learning and Memory in Healthy Individuals and Those With Psychiatric Illness
Condition: Psychiatric Illness; Healthy
MeSH terms: Mental Disorders
Intervention: GLYX-13; Placebo
Intervention description: Single injection (5 mg/kg) of GLYX-13, an NMDAR partial agonist; Single injection of placebo (saline)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: healthy individuals; schizophrenia; schizoaffective disorder; learning; memory; cognitive enhancement; fMRI

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.
    

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