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Ketamine in the Treatment of Depression

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ClinicalTrials.gov Identifier: NCT01558063
Recruitment Status : Active, not recruiting
First Posted : March 20, 2012
Results First Posted : July 16, 2019
Last Update Posted : August 1, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Columbia University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: Ketamine
Drug: Saline
Procedure: Magnetic Resonance Imaging (MRI)
Enrollment 38
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ketamine Dose 1 Ketamine Dose 2 Ketamine Dose 3 Ketamine Dose 4 Ketamine Dose 5 Saline Solution
Hide Arm/Group Description

0.1 mg/kg, IV (in the vein) of Ketamine and MRI scan

Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.

Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.

0.2 mg/kg, IV (in the vein) of Ketamine and MRI scan

Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.

Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.

0.3 mg/kg, IV (in the vein) of Ketamine and MRI scan

Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.

Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.

0.4 mg/kg, IV (in the vein) of Ketamine and MRI scan

Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.

Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.

0.5 mg/kg, IV (in the vein) of Ketamine and MRI scan

Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.

Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.

Saline infused over 40 minutes and MRI scan

Saline: Single infusion of saline given intravenously over 40 minutes.

Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.

Period Title: Overall Study
Started 5 6 8 5 9 5
Completed 5 6 8 5 9 5
Not Completed 0 0 0 0 0 0
Arm/Group Title Ketamine Dose 1 Ketamine Dose 2 Ketamine Dose 3 Ketamine Dose 4 Ketamine Dose 5 Saline Solution Total
Hide Arm/Group Description

0.1 mg/kg, IV (in the vein) of Ketamine and MRI scan

Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.

Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.

0.2 mg/kg, IV (in the vein) of Ketamine and MRI scan

Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.

Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.

0.3 mg/kg, IV (in the vein) of Ketamine and MRI scan

Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.

Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.

0.4 mg/kg, IV (in the vein) of Ketamine and MRI scan

Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.

Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.

0.5 mg/kg, IV (in the vein) of Ketamine and MRI scan

Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.

Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.

Saline infused over 40 minutes and MRI scan

Saline: Single infusion of saline given intravenously over 40 minutes.

Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.

Total of all reporting groups
Overall Number of Baseline Participants 5 6 8 5 9 5 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 6 participants 8 participants 5 participants 9 participants 5 participants 38 participants
37.4  (12.3) 37.8  (8.2) 38.1  (7.2) 30.6  (9.4) 40.2  (14.5) 46.8  (12.3) 38.46  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 8 participants 5 participants 9 participants 5 participants 38 participants
Female
4
  80.0%
5
  83.3%
4
  50.0%
5
 100.0%
5
  55.6%
2
  40.0%
25
  65.8%
Male
1
  20.0%
1
  16.7%
4
  50.0%
0
   0.0%
4
  44.4%
3
  60.0%
13
  34.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 8 participants 5 participants 9 participants 5 participants 38 participants
Hispanic or Latino
1
  20.0%
1
  16.7%
0
   0.0%
1
  20.0%
2
  22.2%
1
  20.0%
6
  15.8%
Not Hispanic or Latino
4
  80.0%
5
  83.3%
8
 100.0%
4
  80.0%
7
  77.8%
4
  80.0%
32
  84.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Responders 24-hours Post-ketamine Infusion
Hide Description The quantitative depressive symptom ratings were collected at Baseline, Day 1 (post ketamine), Day 3 using HDRS-24 (a 24-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery). The total score can range from 0 to a maximum score of 15 with a higher score indicating a worse outcome. A “responder” was defined as an individual exhibiting a reduction in the HDRS score from baseline to 24 hours (day 1) post-treatment, and all other individuals were classified as non-responders.
Time Frame Day 1 (post ketamine)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Dose 1 Ketamine Dose 2 Ketamine Dose 3 Ketamine Dose 4 Ketamine Dose 5 Saline Solution
Hide Arm/Group Description:

0.1 mg/kg, IV (in the vein) of Ketamine and MRI scan

Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.

Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.

0.2 mg/kg, IV (in the vein) of Ketamine and MRI scan

Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.

Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.

0.3 mg/kg, IV (in the vein) of Ketamine and MRI scan

Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.

Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.

0.4 mg/kg, IV (in the vein) of Ketamine and MRI scan

Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.

Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.

0.5 mg/kg, IV (in the vein) of Ketamine and MRI scan

Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.

Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.

Saline infused over 40 minutes and MRI scan

Saline: Single infusion of saline given intravenously over 40 minutes.

Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.

Overall Number of Participants Analyzed 5 6 8 5 9 5
Measure Type: Number
Unit of Measure: participants
3 1 3 2 2 0
2.Secondary Outcome
Title Change in Glutamate Levels
Hide Description The dose-response curve as it refers to ketamine inducing a dose-dependent increase in glutamate levels with 1H Magnetic Resonance Spectroscopy (MRS) will be analyzed.
Time Frame Baseline and 120 minutes after infusion
Hide Outcome Measure Data
Hide Analysis Population Description
The data was not collected at 120 minutes and therefore was not analyzed for this outcome measure.
Arm/Group Title Ketamine Dose 1 Ketamine Dose 2 Ketamine Dose 3 Ketamine Dose 4 Ketamine Dose 5 Saline Solution
Hide Arm/Group Description:

0.1 mg/kg, IV (in the vein) of Ketamine and MRI scan

Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.

Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.

0.2 mg/kg, IV (in the vein) of Ketamine and MRI scan

Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.

Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.

0.3 mg/kg, IV (in the vein) of Ketamine and MRI scan

Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.

Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.

0.4 mg/kg, IV (in the vein) of Ketamine and MRI scan

Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.

Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.

0.5 mg/kg, IV (in the vein) of Ketamine and MRI scan

Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.

Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.

Saline infused over 40 minutes and MRI scan

Saline: Single infusion of saline given intravenously over 40 minutes.

Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.

Overall Number of Participants Analyzed 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change in Gamma-Amino Butyric Acid (GABA) Levels
Hide Description The dose-response curve as it refers to ketamine inducing a dose-dependent increase in GABA levels measured with 1H Magnetic Resonance Spectroscopy (MRS) will be analyzed.
Time Frame Baseline and 120 minutes after infusion
Hide Outcome Measure Data
Hide Analysis Population Description
This data was not collected and therefore was not analyzed.
Arm/Group Title Ketamine Dose 1 Ketamine Dose 2 Ketamine Dose 3 Ketamine Dose 4 Ketamine Dose 5 Saline Solution
Hide Arm/Group Description:

0.1 mg/kg, IV (in the vein) of Ketamine and MRI scan

Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.

Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.

0.2 mg/kg, IV (in the vein) of Ketamine and MRI scan

Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.

Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.

0.3 mg/kg, IV (in the vein) of Ketamine and MRI scan

Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.

Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.

0.4 mg/kg, IV (in the vein) of Ketamine and MRI scan

Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.

Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.

0.5 mg/kg, IV (in the vein) of Ketamine and MRI scan

Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.

Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.

Saline infused over 40 minutes and MRI scan

Saline: Single infusion of saline given intravenously over 40 minutes.

Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.

Overall Number of Participants Analyzed 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Subjects
Hide Arm/Group Description Includes all subjects receiving either saline or ketamine. Safety data was not collected or analyzed per dose level of ketamine.
All-Cause Mortality
All Subjects
Affected / at Risk (%)
Total   0/38 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
All Subjects
Affected / at Risk (%) # Events
Total   4/38 (10.53%)    
General disorders   
Unrelated Medical Illness *  2/38 (5.26%)  2
Product Issues   
Antidepressant Misuse *  1/38 (2.63%)  1
Psychiatric disorders   
Active Suicidal Ideation *  1/38 (2.63%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Subjects
Affected / at Risk (%) # Events
Total   0/38 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: J. John Mann, MD
Organization: Columbia University
Phone: 646-774-7553
EMail: jjm@columbia.edu
Layout table for additonal information
Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT01558063     History of Changes
Other Study ID Numbers: NYSPI 6460
5R01MH093637-03 ( U.S. NIH Grant/Contract )
First Submitted: March 16, 2012
First Posted: March 20, 2012
Results First Submitted: April 11, 2019
Results First Posted: July 16, 2019
Last Update Posted: August 1, 2019