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Trial record 1 of 1 for:    17460065 [PUBMED-IDS]
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The Effects of Ketamine and Guanfacine on Working Memory in Healthy Subjects (GuaKet)

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ClinicalTrials.gov Identifier: NCT01600885
Recruitment Status : Completed
First Posted : May 17, 2012
Results First Posted : October 28, 2014
Last Update Posted : August 21, 2017
Sponsor:
Collaborator:
VA Office of Research and Development
Information provided by (Responsible Party):
Yale University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition: NMDA Receptor Function
Interventions: Drug: Guanfacine
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow for 3 periods

Period 1:   First Period
    Guanfacine Then Placebo   Placebo Then Guanfacine
STARTED   10   9 
COMPLETED   8   8 
NOT COMPLETED   2   1 
Adverse Event                1                1 
moved out of area                1                0 

Period 2:   Wash Out Period
    Guanfacine Then Placebo   Placebo Then Guanfacine
STARTED   8   8 
COMPLETED   8   8 
NOT COMPLETED   0   0 

Period 3:   Second Period
    Guanfacine Then Placebo   Placebo Then Guanfacine
STARTED   8   8 
COMPLETED   8   8 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline population is the number of participants who started the study

Reporting Groups
  Description
Overall Study 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.

Baseline Measures
   Overall Study 
Overall Participants Analyzed 
[Units: Participants]
 19 
Age 
[Units: Years]
Mean (Standard Deviation)
 30  (6.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      9  47.4% 
Male      10  52.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      2  10.5% 
Not Hispanic or Latino      17  89.5% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      1   5.3% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      3  15.8% 
White      13  68.4% 
More than one race      0   0.0% 
Unknown or Not Reported      2  10.5% 


  Outcome Measures

1.  Primary:   Percent Change in Amelioration of Ketamine-related Task Activation as Measured by Functional Magnetic Resonance Imaging in Inferior Parietal Lobule   [ Time Frame: Within 4 hours of dose administration, after up to 1.25 hours of ketamine infusion ]

2.  Primary:   Percent Change in Amelioration of Ketamine-related Task Activation as Measured by Functional Magnetic Resonance Imaging in Middle Frontal Gyrus   [ Time Frame: Within 4 hours of dose administration, after up to 1.25 hours of ketamine infusion ]

3.  Primary:   Percent Change in Amelioration of Ketamine-related Task Activation as Measured by Functional Magnetic Resonance Imaging in Superior Frontal Gyrus   [ Time Frame: Within 4 hours of dose administration, after up to 1.25 hours of ketamine infusion ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: John Krystal, MD
Organization: Yale University
phone: 203-785-6396
e-mail: john.krystal@yale.edu


Publications:
Brandt, J. The Hopkins Verbal Learning Test: development of a new memory test with six equivalent forms The Clinical Neuropsychologist 125-142, 1991
Kaye, S., L. Opler, et al. (1986) Positive and Negative Syndrome Scale. Toronto, Ontario. Multi-Health Systems, Inc.
Newcomer, J., N. Farber, et al. (1999).


Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01600885     History of Changes
Other Study ID Numbers: 0807004092
First Submitted: May 15, 2012
First Posted: May 17, 2012
Results First Submitted: August 29, 2014
Results First Posted: October 28, 2014
Last Update Posted: August 21, 2017