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PET Imaging of mGLuR5 With Drug Challenge

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01691092
First Posted: September 24, 2012
Last Update Posted: April 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yale University
Results First Submitted: December 21, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions: Major Depressive Disorder
Post-Traumatic Stress Disorder (PTSD)
Intervention: Drug: Ketamine

  Participant Flow
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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
Ketamine

All subjects will receive ketamine

Ketamine: All subjects will receive ketamine to induce glutamate release in the brain


Participant Flow:   Overall Study
    Ketamine
STARTED   79 
COMPLETED   38 
NOT COMPLETED   41 
Lost to Follow-up                10 
Physician Decision                4 
Withdrawal by Subject                3 
non-compliance                3 
used for different study                2 
screen fail                19 



  Baseline Characteristics
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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.
reason for discrepancy: some subjects completed baseline scan but did not continue with ketamine administration and subsequent scans.

Reporting Groups
  Description
Ketamine

All subjects will receive ketamine

Ketamine: All subjects will receive ketamine to induce glutamate release in the brain


Baseline Measures
   Ketamine 
Overall Participants Analyzed 
[Units: Participants]
 42 
Age 
[Units: Years]
Mean (Standard Deviation)
 34.07143  (12.12615) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      28  66.7% 
Male      14  33.3% 
diagnosis 
[Units: Participants]
Count of Participants
 
Healthy Control (HC)      20  47.6% 
Major Depressive Disorder (MDD)      14  33.3% 
Post-Traumatic Stress Disorder (PTSD)      4   9.5% 
Comorbid MDD & PTSD      4   9.5% 


  Outcome Measures

1.  Primary:   Change in Glutamate Levels at Baseline and After Ketamine Administration as Confirmed by Positron Emission Tomography (PET) Imaging   [ Time Frame: 1st scan: 90 minute baseline scan; 2nd scan: 90 minutes, ketamine administration at start of scan; scan 3: 90 minute scan 24 hours post ketamine ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Study lacks placebo control group Hemodynamic effects of ketamine may alter tracer delivery and washout Study lacks long-term follow up Only non-smokers studied Ketamine dose administered is higher than typical dose used for clinical purposes


  More Information
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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: Irina Esterlis, Ph.D.
Organization: Yale University - Psychiatry Department
phone: (203)737-6820
e-mail: irina.esterlis@yale.edu



Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01691092     History of Changes
Other Study ID Numbers: 1111009365
First Submitted: September 19, 2012
First Posted: September 24, 2012
Results First Submitted: December 21, 2016
Results First Posted: April 21, 2017
Last Update Posted: April 21, 2017