A Phase 2 interventional study of GLYX-13 and Placebo in Psychiatric Illness and Healthy, sponsored by Northwestern University. Terminated at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-20.
Sponsored by Northwestern University · Phase 2, Interventional, and Treatment
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 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.
2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.
This study's enrollment of 44 is below the median of 94 across 1,574 interventional studies indexed under Mental Disorders.
Browse Mental Disorders studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
For all Individuals
For Patients
-Diagnosis of Schizophrenia or Schizoaffective Disorder
Exclusion Criteria:
For all individuals:
For Healthy Individuals
For Patients
Single IV infusion of GLYX-13, 5mg/kg,
Drug: GLYX-13
Single IV administration of placebo
Drug: Placebo
Single injection (5 mg/kg) of GLYX-13, an NMDAR partial agonist
Single injection of placebo (saline)
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.
Time frame: within 1 hour of administration
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.
Time frame: within 1 hour of administration
| Milestone | GLYX-13 | Placebo |
|---|---|---|
| Started | 22 | 22 |
| Completed | 21 | 21 |
| Not completed | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Excessive motion in mri resulted in discontinuation. | 1 | 0 |
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.
| percentage of BOLD signal change | GLYX-13 | Placebo |
|---|---|---|
| Percentage of Change in fMRI BOLD Signal During a Category Learning Task | .16 ± .16 | .08 ± .15 |
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.
| percentage of correct trials | GLYX-13 | Placebo |
|---|---|---|
| Category Learning Behavioral Performance | 72.5 ± 16.4 | 75.2 ± 14.0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GLYX-13 | 0/21 (0%) | 0/21 (0%) | 9/21 (42.9%) |
| Placebo | 0/21 (0%) | 0/21 (0%) | 9/21 (42.9%) |
| Event | GLYX-13 | Placebo |
|---|---|---|
| HeadacheNervous system disorders | 4/21 | 2/21 |
| Injection discomfortInjury, poisoning and procedural complications | 0/21 | 2/21 |
| DizzinessNervous system disorders | 1/21 | 0/21 |
| FatigueNervous system disorders | 1/21 | 1/21 |
| Back painMusculoskeletal and connective tissue disorders | 0/21 | 1/21 |
| Muscle spasmMusculoskeletal and connective tissue disorders | 1/21 | 0/21 |
| PalpitationCardiac disorders | 1/21 | 0/21 |
| NauseaGastrointestinal disorders | 1/21 | 1/21 |
| DiarrheaGastrointestinal disorders | 0/21 | 1/21 |
| VomittingGastrointestinal disorders | 0/21 | 1/21 |
| Age, Categorical(Participants) | GLYX-13 | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 21 | 21 | 42 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | GLYX-13 | Placebo | Total |
|---|---|---|---|
| Mean | 27.2 ± 4.5 | 25.2 ± 5.0 | 26.2 ± 4.8 |
| Sex: Female, Male(Participants) | GLYX-13 | Placebo | Total |
|---|---|---|---|
| Female | 11 | 11 | 22 |
| Male | 10 | 10 | 20 |
| Race (NIH/OMB)(Participants) | GLYX-13 | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 3 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 5 | 9 |
| White | 14 | 13 | 27 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | GLYX-13 | Placebo | Total |
|---|---|---|---|
| United States | 21 | 21 | 42 |
| Estimated Intelligence Quotient (IQ)(units on a scale) | GLYX-13 | Placebo | Total |
|---|---|---|---|
| Mean | 105.7 ± 9.2 | 107.9 ± 8.8 | 106.8 ± 9.0 |
This study is terminated, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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