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PET Imaging of mGLuR5 With Drug Challenge

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.
 
ClinicalTrials.gov Identifier: NCT01691092
Recruitment Status : Completed
First Posted : September 24, 2012
Results First Posted : April 21, 2017
Last Update Posted : April 21, 2017
Sponsor:
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Major Depressive Disorder
Post-Traumatic Stress Disorder (PTSD)
Intervention Drug: Ketamine
Enrollment 79
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ketamine
Hide Arm/Group Description

All subjects will receive ketamine

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

Period Title: Overall Study
Started 79
Completed 38
Not Completed 41
Reason Not Completed
Lost to Follow-up             10
Physician Decision             4
Withdrawal by Subject             3
non-compliance             3
used for different study             2
screen fail             19
Arm/Group Title Ketamine
Hide Arm/Group Description

All subjects will receive ketamine

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

Overall Number of Baseline Participants 42
Hide Baseline Analysis Population Description
reason for discrepancy: some subjects completed baseline scan but did not continue with ketamine administration and subsequent scans.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants
34.07143  (12.12615)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Female
28
  66.7%
Male
14
  33.3%
diagnosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 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%
1.Primary Outcome
Title Change in Glutamate Levels at Baseline and After Ketamine Administration as Confirmed by Positron Emission Tomography (PET) Imaging
Hide Description PET imaging obtained in healthy and Major Depressive Disorder (MDD) subjects. Glutamate levels determined by radiotracer uptake in PET images.
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
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Hide Analysis Population Description
13 healthy (6 males, 7 females) and 14 MDD non-smokers (4 males, 10 females) Mean age: 33.5 ± 13.2 yrs reasons for discrepancy (participant flow module): some data was not able to be analyzed due to elevated metabolites; some subject did not tolerate ketamine and had to be pulled out of scanner so we could not obtain data.
Arm/Group Title Ketamine
Hide Arm/Group Description:

All subjects will receive ketamine

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

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: percentage reduction
HC % reduction from baseline immediately post ket 19  (22)
MDD % reduction from baseline immediately post ket 14  (9)
HC % reduction from baseline 24 hrs post ket 31  (30)
MDD % reduction from baseline 24 hrs post ket 14  (13)
Time Frame 4 years
Adverse Event Reporting Description Standard assessments and regular observations are used to determine whether or not certain adverse events have occurred.
 
Arm/Group Title Ketamine
Hide Arm/Group Description

All subjects will receive ketamine

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

All-Cause Mortality
Ketamine
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Ketamine
Affected / at Risk (%) # Events
Total   1/38 (2.63%)    
General disorders   
post-ketamine non-responsiveness  [1]  1/38 (2.63%)  1
Indicates events were collected by systematic assessment
[1]
Post-ketamine subject was non-responsive to questions- did not respond to verbal arousal. Subject was clinically stable. Sent to ER where it was believed the experience was dissociative event due to ketamine.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ketamine
Affected / at Risk (%) # Events
Total   0/38 (0.00%)    
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
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
Layout table for Results Point of Contact information
Name/Title: Irina Esterlis, Ph.D.
Organization: Yale University - Psychiatry Department
Phone: (203)737-6820
EMail: irina.esterlis@yale.edu
Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01691092    
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