An interventional study of Guanfacine and Placebo in NMDA Receptor Function, sponsored by Yale University. Completed at 3 sites in United States. Open to participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-21.
Sponsored by Yale University · Not applicable, Interventional, and Basic science
The purpose of the study is
Potential subjects will be interviewed over the phone and, if appropriate, will be scheduled for a screening session. Participants who meet study criteria will participate in two study sessions separated by at least two weeks. The sessions will be identical except on one day they will receive guanfacine and on the other, they will receive a placebo.
This study was initially completed in 2014. Upon analysis of the collected data, it was decided to add additional subjects and gather additional data to verify results seen in the collected data. The study was reopened and new data was added beginning in September 2016. Information about the study beginning in 2016 is available in a separate record.
Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
During the first study session, the participant will receive guanfacine before undergoing a ketamine-infusion fMRI. During the second study session, at least two weeks later, the participant will receive a placebo before undergoing a ketamine-infusion fMRI.
Drug: Guanfacine · Drug: Placebo
During the first study session, the participant will receive a placebo before undergoing a ketamine-infusion fMRI. During the second study session, at least two weeks later, the participant will receive guanfacine before undergoing a ketamine-infusion fMRI.
Drug: Guanfacine · Drug: Placebo
Subjects will be given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) will be given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant will receive a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation will be measured during a spatial working memory task. The entire scan will last approximately two and a half hours and the ketamine infusion will be up to one hour and 15 minutes.
Subjects will be given a placebo before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) will be given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant will receive a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation will be measured during a spatial working memory task. The entire scan will last approximately two and a half hours and the ketamine infusion will be up to one hour and 15 minutes.
Percent Change in Amelioration of Ketamine-related Task Activation as Measured by Functional Magnetic Resonance Imaging in Inferior Parietal Lobule
Scans will be analyzed for task-related prefrontal activation Difference Score: Percent Signal Change in Regions of Interest (ketamine - saline)
Time frame: Within 4 hours of dose administration, after up to 1.25 hours of ketamine infusion
Percent Change in Amelioration of Ketamine-related Task Activation as Measured by Functional Magnetic Resonance Imaging in Middle Frontal Gyrus
Difference Score: Percent Signal Change in Regions of Interest (ketamine - saline)
Time frame: Within 4 hours of dose administration, after up to 1.25 hours of ketamine infusion
Percent Change in Amelioration of Ketamine-related Task Activation as Measured by Functional Magnetic Resonance Imaging in Superior Frontal Gyrus
Difference Score: Percent Signal Change in Regions of Interest (ketamine - saline)
Time frame: Within 4 hours of dose administration, after up to 1.25 hours of ketamine infusion
| Milestone | Guanfacine Then Placebo | Placebo Then Guanfacine |
|---|---|---|
| Started | 10 | 9 |
| Completed | 8 | 8 |
| Not completed | 2 | 1 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Moved out of area | 1 | 0 |
| Milestone | Guanfacine Then Placebo | Placebo Then Guanfacine |
|---|---|---|
| Started | 8 | 8 |
| Completed | 8 | 8 |
| Not completed | 0 | 0 |
| Milestone | Guanfacine Then Placebo | Placebo Then Guanfacine |
|---|---|---|
| Started | 8 | 8 |
| Completed | 8 | 8 |
| Not completed | 0 | 0 |
Scans will be analyzed for task-related prefrontal activation Difference Score: Percent Signal Change in Regions of Interest (ketamine - saline)
| percent change in saline signal | Guanfacine | Placebo |
|---|---|---|
| Percent Change in Amelioration of Ketamine-related Task Activation as Measured by Functional Magnetic Resonance Imaging in Inferior Parietal Lobule | -0.17 ± 0.046 | -0.094 ± 0.054 |
Difference Score: Percent Signal Change in Regions of Interest (ketamine - saline)
| percent change in saline signal | Guanfacine | Placebo |
|---|---|---|
| Percent Change in Amelioration of Ketamine-related Task Activation as Measured by Functional Magnetic Resonance Imaging in Middle Frontal Gyrus | -0.1 ± 0.052 | 0.052 ± 0.0652 |
Difference Score: Percent Signal Change in Regions of Interest (ketamine - saline)
| percent change in saline signal | Guanfacine | Placebo |
|---|---|---|
| Percent Change in Amelioration of Ketamine-related Task Activation as Measured by Functional Magnetic Resonance Imaging in Superior Frontal Gyrus | -0.134 ± 0.0413 | -0.086 ± 0.0365 |
Collected over Throughout the length of the study (Aproximately 3 years). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Guanfacine | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Placebo | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
Baseline population is the number of participants who started the study
| Age, Continuous(years) | Overall Study |
|---|---|
| Mean | 30 ± 6.4 |
| Sex: Female, Male(Participants) | Overall Study |
|---|---|
| Female | 9 |
| Male | 10 |
| Ethnicity (NIH/OMB)(Participants) | Overall Study |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 17 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Overall Study |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 13 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Yale University