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Ketamine for Depression: An MRI Study

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ClinicalTrials.gov Identifier: NCT02544607
Recruitment Status : Completed
First Posted : September 9, 2015
Results First Posted : April 4, 2019
Last Update Posted : April 16, 2019
Sponsor:
Collaborators:
Brain & Behavior Research Foundation
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Cristina Cusin, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Depression
Anxious Depression
Major Depressive Disorder
Interventions Drug: Ketamine
Other: Magnetic Resonance Imaging (MRI)
Enrollment 25
Recruitment Details As specified, the total number of participants enrolled are those who agreed to participate in the study following completion of the informed consent process (n=25). This number does not reflect the number of subjects who actually started treatment (n=16).
Pre-assignment Details  
Arm/Group Title Ketamine + MRI
Hide Arm/Group Description

All eligible participants will receive open label ketamine and undergo Magnetic Resonance Imaging

Ketamine: Ketamine 0.5mg/kg over 40 minutes IV

Period Title: Overall Study
Started 16
Completed 16
Not Completed 0
Arm/Group Title Ketamine
Hide Arm/Group Description

All eligible participants will receive open label ketamine

Ketamine: Ketamine 0.5mg/kg over 40 minutes IV

Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
<=18 years
0
   0.0%
Between 18 and 65 years
16
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
42  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
8
  50.0%
Male
8
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Hispanic or Latino
1
   6.3%
Not Hispanic or Latino
15
  93.8%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   6.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
14
  87.5%
More than one race
0
   0.0%
Unknown or Not Reported
1
   6.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants
16
1.Primary Outcome
Title Change in Hamilton Depression Rating Scale (HDRS) From Baseline/Minute 0 to 4 Hours Post-infusion.
Hide Description

Hamilton Depression Rating Scale; possible scores range from 0 to 81 with higher scores indicating higher depression symptoms

Change will be calculated by difference between HDRS from Minute 0 to Minute 240.

Time Frame 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine
Hide Arm/Group Description:

All eligible participants will receive open label ketamine

Ketamine: Ketamine 0.5mg/kg over 40 minutes IV

Overall Number of Participants Analyzed 16
Mean (Full Range)
Unit of Measure: score on a scale
-9.625
(-25 to 6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ketamine
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Percent Change in Tissue Fractional Anisotropy Quantification (Left Inferior Longitudinal Fasciculus)
Hide Description Free-water imaging, a two-compartment diffusion model, was employed to quantify tissue fractional anisotropy (FAt) pre- and post-infusion
Time Frame 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Reasons for missing data (N=3) included a scanner malfunction and participant requests to stop scanning prior to dMRI sequence acquisition.
Arm/Group Title Ketamine + MRI
Hide Arm/Group Description:

All eligible participants will receive open label ketamine and undergo Magnetic Resonance Imaging (MRI).

Ketamine: Ketamine 0.5mg/kg over 40 minutes IV

Magnetic Resonance Imaging (MRI): MRI technology will be used before and after ketamine for patients with depression

Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: percent change
.901
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ketamine + MRI
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.048
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Percent Change in Tissue Fractional Anisotropy Quantification (Right Inferior Longitudinal Fasciculus)
Hide Description Free-water imaging, a two-compartment diffusion model, was employed to quantify tissue fractional anisotropy (FAt) pre- and post-infusion
Time Frame 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Reasons for missing data (N=3) included a scanner malfunction and participant requests to stop scanning prior to dMRI sequence acquisition.
Arm/Group Title Ketamine + MRI
Hide Arm/Group Description:

All eligible participants will receive open label ketamine and undergo Magnetic Resonance Imaging (MRI).

Ketamine: Ketamine 0.5mg/kg over 40 minutes IV

Magnetic Resonance Imaging (MRI): MRI technology will be used before and after ketamine for patients with depression

Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: percent change
1.247
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ketamine + MRI
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Percent Change in Tissue Fractional Anisotropy Quantification (Left Superior Longitudinal Fasciculus)
Hide Description Free-water imaging, a two-compartment diffusion model, was employed to quantify tissue fractional anisotropy (FAt) pre- and post-infusion
Time Frame 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Reasons for missing data (N=3) included a scanner malfunction and participant requests to stop scanning prior to dMRI sequence acquisition.
Arm/Group Title Ketamine + MRI
Hide Arm/Group Description:

All eligible participants will receive open label ketamine and undergo Magnetic Resonance Imaging (MRI).

Ketamine: Ketamine 0.5mg/kg over 40 minutes IV

Magnetic Resonance Imaging (MRI): MRI technology will be used before and after ketamine for patients with depression

Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: percent change
.696
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ketamine + MRI
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0499
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Percent Change in Tissue Fractional Anisotropy Quantification (Right Uncinate Fasciculus)
Hide Description Free-water imaging, a two-compartment diffusion model, was employed to quantify tissue fractional anisotropy (FAt) pre- and post-infusion
Time Frame 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Reasons for missing data (N=3) included a scanner malfunction and participant requests to stop scanning prior to dMRI sequence acquisition.
Arm/Group Title Ketamine + MRI
Hide Arm/Group Description:

All eligible participants will receive open label ketamine and undergo Magnetic Resonance Imaging (MRI).

Ketamine: Ketamine 0.5mg/kg over 40 minutes IV

Magnetic Resonance Imaging (MRI): MRI technology will be used before and after ketamine for patients with depression

Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: percent change
1.158
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ketamine + MRI
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.038
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Adverse event data were collected throughout the course of the study. The collection of this data took place at the initial screen, continuously throughout the duration of the administration visit (e.g. Visit 2), 24 hours post-administration, and up to 3 months following the administration visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketamine
Hide Arm/Group Description

All eligible participants will receive open label ketamine

Ketamine: Ketamine 0.5mg/kg over 40 minutes IV

All-Cause Mortality
Ketamine
Affected / at Risk (%)
Total   0/16 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Ketamine
Affected / at Risk (%)
Total   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ketamine
Affected / at Risk (%)
Total   1/16 (6.25%) 
Eye disorders   
bilateral nystagmus   1/16 (6.25%) 
Indicates events were collected by 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: Dr. Cristina Cusin
Organization: Massachusetts General Hospital
Phone: 617-726-6421
EMail: ccusin@mgh.harvard.edu
Layout table for additonal information
Responsible Party: Cristina Cusin, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02544607     History of Changes
Other Study ID Numbers: 2015P001912
24032 ( Other Grant/Funding Number: 2015 NARSAD Young Investigator Grant )
First Submitted: September 4, 2015
First Posted: September 9, 2015
Results First Submitted: August 14, 2018
Results First Posted: April 4, 2019
Last Update Posted: April 16, 2019