Trial Outcomes & Findings for The Effects of Ketamine and Guanfacine on Working Memory in Healthy Subjects (NCT NCT01600885)
NCT ID: NCT01600885
Last Updated: 2017-08-21
Results Overview
Scans will be analyzed for task-related prefrontal activation Difference Score: Percent Signal Change in Regions of Interest (ketamine - saline)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
Within 4 hours of dose administration, after up to 1.25 hours of ketamine infusion
Results posted on
2017-08-21
Participant Flow
Participant milestones
| Measure |
Guanfacine Then Placebo
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.
Guanfacine then Placebo: During the first study session, the patient 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.
The second study session will be identical except that the patient will be given a placebo instead of the guanfacine.
|
Placebo Then Guanfacine
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.
Placebo then Guanfacine: During the first study session, the patient 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.
The second study session will be identical except that the patient will be given 3mg of guanfacine instead of the placebo.
|
|---|---|---|
|
First Period
STARTED
|
10
|
9
|
|
First Period
COMPLETED
|
8
|
8
|
|
First Period
NOT COMPLETED
|
2
|
1
|
|
Wash Out Period
STARTED
|
8
|
8
|
|
Wash Out Period
COMPLETED
|
8
|
8
|
|
Wash Out Period
NOT COMPLETED
|
0
|
0
|
|
Second Period
STARTED
|
8
|
8
|
|
Second Period
COMPLETED
|
8
|
8
|
|
Second Period
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Guanfacine Then Placebo
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.
Guanfacine then Placebo: During the first study session, the patient 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.
The second study session will be identical except that the patient will be given a placebo instead of the guanfacine.
|
Placebo Then Guanfacine
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.
Placebo then Guanfacine: During the first study session, the patient 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.
The second study session will be identical except that the patient will be given 3mg of guanfacine instead of the placebo.
|
|---|---|---|
|
First Period
Adverse Event
|
1
|
1
|
|
First Period
moved out of area
|
1
|
0
|
Baseline Characteristics
The Effects of Ketamine and Guanfacine on Working Memory in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Overall Study
n=19 Participants
This 'arm' consists of all study participants who started the first Study Period. This Study Period consisted of an initial screening visit in which it was determined whether participants met the inclusion/exclusion criteria for further participation in this study.
|
|---|---|
|
Age, Continuous
|
30 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 4 hours of dose administration, after up to 1.25 hours of ketamine infusionPopulation: ALL SUBJECTS WHO COMPLETED THE STUDY WERE INCLUDED IN ANALYSIS
Scans will be analyzed for task-related prefrontal activation Difference Score: Percent Signal Change in Regions of Interest (ketamine - saline)
Outcome measures
| Measure |
Guanfacine
n=16 Participants
Subjects were given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the subjects received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
|
Placebo
n=16 Participants
Subjects were given a placebo before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted 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
|
-0.17 percent change in saline signal
Standard Error 0.046
|
-0.094 percent change in saline signal
Standard Error 0.054
|
PRIMARY outcome
Timeframe: Within 4 hours of dose administration, after up to 1.25 hours of ketamine infusionPopulation: ALL SUBJECTS WHO COMPLETED THE STUDY WERE INCLUDED IN ANALYSIS
Difference Score: Percent Signal Change in Regions of Interest (ketamine - saline)
Outcome measures
| Measure |
Guanfacine
n=16 Participants
Subjects were given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the subjects received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
|
Placebo
n=16 Participants
Subjects were given a placebo before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
|
|---|---|---|
|
Percent Change in Amelioration of Ketamine-related Task Activation as Measured by Functional Magnetic Resonance Imaging in Middle Frontal Gyrus
|
-0.1 percent change in saline signal
Standard Error 0.052
|
0.052 percent change in saline signal
Standard Error 0.0652
|
PRIMARY outcome
Timeframe: Within 4 hours of dose administration, after up to 1.25 hours of ketamine infusionPopulation: ALL SUBJECTS WHO COMPLETED THE STUDY WERE INCLUDED IN ANALYSIS
Difference Score: Percent Signal Change in Regions of Interest (ketamine - saline)
Outcome measures
| Measure |
Guanfacine
n=16 Participants
Subjects were given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the subjects received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
|
Placebo
n=16 Participants
Subjects were given a placebo before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
|
|---|---|---|
|
Percent Change in Amelioration of Ketamine-related Task Activation as Measured by Functional Magnetic Resonance Imaging in Superior Frontal Gyrus
|
-0.134 percent change in saline signal
Standard Error 0.0413
|
-0.086 percent change in saline signal
Standard Error 0.0365
|
Adverse Events
Guanfacine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place