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Biomarker Assessment of Glutamatergic Target Engagement

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ClinicalTrials.gov Identifier: NCT02134951
Recruitment Status : Completed
First Posted : May 9, 2014
Results First Posted : February 13, 2018
Last Update Posted : August 17, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Marlene Carlson, New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Healthy Controls
Interventions Drug: Ketamine
Drug: Normal saline
Enrollment 65
Recruitment Details  
Pre-assignment Details 65 subjects were randomized, with results (Number started) reported for the 59 subjects randomized subjects with at least one valid scan
Arm/Group Title Ketamine Placebo
Hide Arm/Group Description

IV infusion of ketamine 0.23mg/kg bolus over 1 minutes followed by 0.58 mg/kg/hr over 30 minutes then 0.29mg/kg/hr over 64 minutes

Ketamine: intravenous infusion of saline solution with ketamine

Placebo group will receive normal saline

Normal saline: Normal saline will be used for placebo in this group

Period Title: Overall Study
Started 39 20
Completed 39 [1] 20 [1]
Not Completed 0 0
[1]
number of subjects with at least one valid scan
Arm/Group Title Ketamine Placebo Total
Hide Arm/Group Description randomized to ketamine randomized to placebo Total of all reporting groups
Overall Number of Baseline Participants 39 20 59
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 20 participants 59 participants
31.1  (9.6) 32.2  (10.2) 31.5  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 20 participants 59 participants
Female
21
  53.8%
16
  80.0%
37
  62.7%
Male
18
  46.2%
4
  20.0%
22
  37.3%
1.Primary Outcome
Title Glutamate + Glutamine (Glx) Response
Hide Description Compare changes in Glx response to infusion of ketamine vs placebo, as measured by proton magnetic resonance spectroscopy (¹H MRS). Calculated by post-pre changes in the Glx over creatinine ratios, with higher values indicating higher Glx/creatinine ratios.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Glx response in 1st 15 minutes post ketamine
Arm/Group Title Ketamine Placebo
Hide Arm/Group Description:

IV infusion of ketamine 0.23mg/kg bolus over 1 minutes followed by 0.58 mg/kg/hr over 30 minutes then 0.29mg/kg/hr over 64 minutes

Ketamine: intravenous infusion of saline solution with ketamine

Placebo group will receive normal saline

Normal saline: Normal saline will be used for placebo in this group

Overall Number of Participants Analyzed 31 16
Mean (Standard Error)
Unit of Measure: Glx over creatinine ratio
0.015  (.002) 0.007  (.003)
2.Other Pre-specified Outcome
Title Pharmacological Blood-oxygen-level Dependent (pharmacoBOLD) Response
Hide Description Compare changes inpharmacoBOLD in response to infusion of ketamine vs. placebo, as measured by resting state functional magnetic resonance imaging. Calculated by post-pre changes, with higher values indicating higher response
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Placebo
Hide Arm/Group Description:

IV infusion of ketamine 0.23mg/kg bolus over 1 minutes followed by 0.58 mg/kg/hr over 30 minutes then 0.29mg/kg/hr over 64 minutes

Ketamine: intravenous infusion of saline solution with ketamine

Placebo group will receive normal saline

Normal saline: Normal saline will be used for placebo in this group

Overall Number of Participants Analyzed 34 19
Mean (Standard Error)
Unit of Measure: BOLD signal units
.91  (.1) -0.27  (0.14)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketamine Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Ketamine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)      0/20 (0.00%)    
Hide Serious Adverse Events
Ketamine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/39 (0.00%)      0/20 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ketamine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/39 (15.38%)      0/20 (0.00%)    
Psychiatric disorders     
ketamine psychological effect *  6/39 (15.38%)  6 0/20 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
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: Marlene Carlson
Organization: New York State Psychiatric Institute
Phone: 646-774-8436
EMail: mc157@columbia.edu
Layout table for additonal information
Responsible Party: Marlene Carlson, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02134951    
Other Study ID Numbers: 6925
HHS-N-271-2012-0000-7-I ( Other Identifier: NIH/NIMH contract number )
First Submitted: May 7, 2014
First Posted: May 9, 2014
Results First Submitted: June 8, 2017
Results First Posted: February 13, 2018
Last Update Posted: August 17, 2018