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Ketamine for Depression and Suicide Risk (Ketamine)

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ClinicalTrials.gov Identifier: NCT02094898
Recruitment Status : Completed
First Posted : March 24, 2014
Results First Posted : August 11, 2017
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
William V. Bobo, M.D., Mayo Clinic

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Depression
Suicide
Intervention Drug: Ketamine
Enrollment 12
Recruitment Details Subjects were enrolled at Mayo Clinic in Rochester, Minnesota between 12/30/14 and 5/18/16.
Pre-assignment Details  
Arm/Group Title Ketamine Infusion
Hide Arm/Group Description

This trial was conducted in 2 phases. During the acute-phase, i.v. ketamine was administered thrice-weekly for up to 2 weeks.Those who achieved depressive symptom remission received continuation-phase treatment that consisted of once-weekly i.v. ketamine infusions for 4 additional weeks. Remission could occur after any of the 6 acute-phase infusions, at which point the next infusion was the first (of four) continuation-phase infusions. Individuals who remitted during acute-phase and completed continuation-phase treatment had 4 additional weekly post-continuation follow-up visits.

Ketamine: 0.3 mg/kg/hr of ketamine infused for 100 minutes

Period Title: Overall Study
Started 12
Completed 7
Not Completed 5
Reason Not Completed
Clinical Worsening             2
Adverse Event             2
Lack of Efficacy             1
Arm/Group Title Ketamine Infusion
Hide Arm/Group Description

This trial was conducted in 2 phases. During the acute-phase, i.v. ketamine was administered thrice-weekly for up to 2 weeks.Those who achieved depressive symptom remission received continuation-phase treatment that consisted of once-weekly i.v. ketamine infusions for 4 additional weeks. Remission could occur after any of the 6 acute-phase infusions, at which point the next infusion was the first (of four) continuation-phase infusions. Individuals who remitted during acute-phase and completed continuation-phase treatment had 4 additional weekly post-continuation follow-up visits.

Ketamine: 0.3 mg/kg/hr of ketamine infused for 100 minutes

Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
45.8  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
11
  91.7%
Male
1
   8.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title MADRS Total Score at Baseline and Last Acute Phase Observation
Hide Description The Montgomery Asberg Depression Scale (MADRS) is a 10-item observer rating scale assessing symptoms of depression. The score ranges from 0 (no depression) to 60 (very depressed). For this study a score of less than or equal to 9 was considered clinical remission of depression.
Time Frame baseline, last acute phase observation (approximately 2 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.
Arm/Group Title Entire Cohort Remission Non-Remission
Hide Arm/Group Description:
All enrolled subjects receiving at least one acute-phase ketamine infusion.
Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
Overall Number of Participants Analyzed 12 5 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 29.4  (7.5) 29.4  (8.2) 29.4  (7.7)
Last acute phase observation 15.9  (10.6) 5.4  (3.4) 23.4  (6.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Entire Cohort
Comments alpha level of 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Remission
Comments alpha level of 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title MADRS Total Score, Percent Change From Baseline at Last Acute Phase Observation
Hide Description The Montgomery Asberg Depression Scale (MADRS) is a 10-item observer rating scale assessing symptoms of depression. The score ranges from 0 (no depression) to 60 (very depressed). For this study a score of less than or equal to 9 was considered clinical remission of depression.
Time Frame baseline, last acute phase observation (approximately 2 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.
Arm/Group Title Entire Cohort Remission Non-Remission
Hide Arm/Group Description:
All enrolled subjects receiving at least one acute-phase ketamine infusion.
Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
Overall Number of Participants Analyzed 12 5 7
Mean (Standard Deviation)
Unit of Measure: percentage change in score
-41.5  (40.3) -79.1  (13.0) -14.5  (11.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remission
Comments alpha level of 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title MADRS Factor 1 Score at Baseline and Last Acute Phase Observation
Hide Description The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 1 (Sadness) consisted of MADRS items 1 (Apparent Sadness) and 2 (Reported Sadness). The MADRS Factor 1 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12.
Time Frame baseline, last acute phase observation (approximately 2 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.
Arm/Group Title Entire Cohort Remission Non-Remission
Hide Arm/Group Description:
All enrolled subjects receiving at least one acute-phase ketamine infusion.
Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
Overall Number of Participants Analyzed 12 5 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 7.4  (2.0) 7.4  (2.6) 7.4  (1.7)
Last acute phase observation 3.5  (2.3) 1.2  (0.5) 5.1  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Entire Cohort
Comments alpha level of 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Remission
Comments alpha level of 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Non-Remission
Comments alpha level of 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.08
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title MADRS Factor 1 Score, Percent Change From Baseline at Last Acute Phase Observation
Hide Description The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 1 (Sadness) consisted of MADRS items 1 (Apparent Sadness) and 2 (Reported Sadness). The MADRS Factor 1 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12.
Time Frame baseline, last acute phase observation
Hide Outcome Measure Data
Hide Analysis Population Description
Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.
Arm/Group Title Entire Cohort Remission Non-Remission
Hide Arm/Group Description:
All enrolled subjects receiving at least one acute-phase ketamine infusion.
Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
Overall Number of Participants Analyzed 12 5 7
Mean (Standard Deviation)
Unit of Measure: percentage change in score
-50.3  (35.7) -83.6  (15.7) -26.5  (24.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remission
Comments alpha level of 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title MADRS Factor 2 Score at Baseline and Last Acute Phase Observation
Hide Description The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 2 (Negative Thoughts) consisted of MADRS items 9 (Pessimistic Thoughts) and 10 (Suicidal Thoughts). The MADRS Factor 2 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12.
Time Frame baseline, last acute phase observation (approximately 2 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.
Arm/Group Title Entire Cohort Remission Non-Remission
Hide Arm/Group Description:
All enrolled subjects receiving at least one acute-phase ketamine infusion.
Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
Overall Number of Participants Analyzed 12 5 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 6.0  (1.5) 6.2  (1.6) 5.9  (1.6)
Last acute phase observation 3.4  (1.7) 1.8  (1.5) 4.6  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Entire Cohort
Comments alpha level of 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Remission
Comments alpha level of 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.08
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title MADRS Factor 2 Score, Percentage Change From Baseline at Last Acute Phase Observation
Hide Description The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 2 (negative thoughts) consisted of MADRS items 9 (Pessimistic Thoughts) and 10 (Suicidal Thoughts). The MADRS Factor 2 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12.
Time Frame baseline, last acute phase observation (approximately 2 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.
Arm/Group Title Entire Cohort Remission Non-Remission
Hide Arm/Group Description:
All enrolled subjects receiving at least one acute-phase ketamine infusion.
Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
Overall Number of Participants Analyzed 12 5 7
Mean (Standard Deviation)
Unit of Measure: percentage change in score
-37.0  (36.5) -65.4  (31.4) -16.7  (25.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remission
Comments alpha level of 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title MADRS Factor 3 Score at Baseline and Last Acute Phase Observation
Hide Description The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 3 (Detachment) consisted of MADRS items 6 - 8 (Concentration Difficulties, Lassitude, and Inability to Feel). The MADRS Factor 3 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18.
Time Frame baseline, last acute phase observation (approximately 2 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.
Arm/Group Title Entire Cohort Remission Non-Remission
Hide Arm/Group Description:
All enrolled subjects receiving at least one acute-phase ketamine infusion.
Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
Overall Number of Participants Analyzed 12 5 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 9.5  (3.1) 9.8  (2.7) 9.3  (3.5)
Last acute phase observation 4.9  (3.5) 1.4  (1.3) 7.4  (1.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Entire Cohort
Comments alpha level of 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Remission
Comments alpha level of 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title MADRS Factor 3 Score, Percentage Change From Baseline at Last Acute Phase Observation
Hide Description The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 3 (detachment) consisted of MADRS items 6 - 8 (Concentration Difficulties, Lassitude, and Inability to Feel). The MADRS Factor 3 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18.
Time Frame baseline, last acute phase observation (approximately 2 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.
Arm/Group Title Entire Cohort Remission Non-Remission
Hide Arm/Group Description:
All enrolled subjects receiving at least one acute-phase ketamine infusion.
Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
Overall Number of Participants Analyzed 12 5 7
Mean (Standard Deviation)
Unit of Measure: percentage change in score
-40.2  (48.5) -84.3  (14.8) -8.9  (37.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remission
Comments alpha level of 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
9.Secondary Outcome
Title MADRS Factor 4 Score at Baseline and Last Acute Phase Observation
Hide Description The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 4 (Neurovegetative Symptoms) consisted of MADRS items 3-5 (Inner Tension, Reduced Sleep, and Reduced Appetite). The MADRS Factor 4 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18.
Time Frame baseline, last acute phase observation (approximately 2 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Statistical analyses included all subjects who received at least one acute-phase ketamine infusion
Arm/Group Title Entire Cohort Remission Non-Remission
Hide Arm/Group Description:
All enrolled subjects receiving at least one acute-phase ketamine infusion.
Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
Overall Number of Participants Analyzed 12 5 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 6.5  (3.0) 6.0  (3.8) 6.9  (2.6)
Last acute phase observation 3.8  (3.6) 1.0  (1.2) 5.9  (3.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Entire Cohort
Comments alpha level of 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.08
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Remission
Comments alpha level of 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.08
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
10.Secondary Outcome
Title MADRS Factor 4 Score, Percentage Change From Baseline at Last Acute Phase Observation
Hide Description The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 4 (neurovegetative symptoms) consisted of MADRS items 3-5 (Inner Tension, Reduced Sleep, and Reduced Appetite). The MADRS Factor 4 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18.
Time Frame baseline, last acute phase observation (approximately 2 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.
Arm/Group Title Entire Cohort Remission Non-Remission
Hide Arm/Group Description:
All enrolled subjects receiving at least one acute-phase ketamine infusion.
Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
Overall Number of Participants Analyzed 12 5 7
Mean (Standard Deviation)
Unit of Measure: percentage change in score
-36.0  (58.0) -84.3  (20.4) -8.4  (54.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remission
Comments alpha level of 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
11.Secondary Outcome
Title MADRS Suicide Thoughts (Item 10) Score at Last Acute Phase Observation
Hide Description The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. Item 10 scores can range from 0 to 6 (with 0 indicating enjoying life, and 6 indicating explicit plans for suicide.)
Time Frame baseline, last acute phase observation (approximately 2 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.
Arm/Group Title Entire Cohort Remission Non-Remission
Hide Arm/Group Description:
All enrolled subjects receiving at least one acute-phase ketamine infusion.
Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
Overall Number of Participants Analyzed 12 5 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 2.9  (1.1) 3.2  (1.1) 2.7  (1.1)
Last acute phase observation 1.7  (0.8) 1.2  (0.8) 2.2  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Entire Cohort
Comments alpha level of 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Remission
Comments alpha level of 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.08
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
12.Secondary Outcome
Title MADRS Suicide (Item 10) Score, Percentage Change From Baseline at Last Acute Phase Observation
Hide Description The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. Item 10 scores can range from 0 to 6 (with 0 indicating enjoying life, and 6 indicating explicit plans for suicide.)
Time Frame baseline, last acute phase observation (approximately 2 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.
Arm/Group Title Entire Cohort Remission Non-Remission
Hide Arm/Group Description:
All enrolled subjects receiving at least one acute-phase ketamine infusion.
Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
Overall Number of Participants Analyzed 12 5 7
Mean (Standard Deviation)
Unit of Measure: percentage change in score
-26.7  (45.4) -50.0  (46.8) -7.2  (37.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remission
Comments alpha level of 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
13.Secondary Outcome
Title Clinical Global Impression-severity Subscale (CGI-S) at Baseline and Last Acute Phase Observation
Hide Description The Clinical Global Impression Severity Subscale is an observer rated scale that measures illness severity. It has a range of responses from 1 (normal) through to 7 (among the most extremely ill patients).
Time Frame baseline, last acute phase observation (approximately 2 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.
Arm/Group Title Entire Cohort Remission Non-Remission
Hide Arm/Group Description:
All enrolled subjects receiving at least one acute-phase ketamine infusion.
Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
Overall Number of Participants Analyzed 12 5 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 5.6  (0.5) 5.4  (0.5) 5.7  (0.5)
Last acute phase observation 3.9  (1.7) 2.6  (0.9) 4.9  (1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Entire Cohort
Comments alpha level of 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Remission
Comments alpha level of 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
14.Secondary Outcome
Title CGI-S Score, Percentage Change From Baseline at Last Acute Phase Observation
Hide Description The Clinical Global Impression Severity Subscale is an observer rated scale that measures illness severity. It has a range of responses from 1 (normal) through to 7 (among the most extremely ill patients).
Time Frame baseline, last acute phase observation (approximately 2 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.
Arm/Group Title Entire Cohort Remission Non-Remission
Hide Arm/Group Description:
All enrolled subjects receiving at least one acute-phase ketamine infusion.
Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
Overall Number of Participants Analyzed 12 5 7
Mean (Standard Deviation)
Unit of Measure: percentage change in score
-29.4  (30.8) -50.7  (20.3) -14.3  (28.7)
Time Frame 10 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketamine Infusion
Hide Arm/Group Description

This trial was conducted in 2 phases. During the acute-phase, i.v. ketamine was administered thrice-weekly for up to 2 weeks.Those who achieved depressive symptom remission received continuation-phase treatment that consisted of once-weekly i.v. ketamine infusions for 4 additional weeks. Remission could occur after any of the 6 acute-phase infusions, at which point the next infusion was the first (of four) continuation-phase infusions. Individuals who remitted during acute-phase and completed continuation-phase treatment had 4 additional weekly post-continuation follow-up visits.

Ketamine: 0.3 mg/kg/hr of ketamine infused for 100 minutes

All-Cause Mortality
Ketamine Infusion
Affected / at Risk (%)
Total   1/12 (8.33%)    
Show Serious Adverse Events Hide Serious Adverse Events
Ketamine Infusion
Affected / at Risk (%) # Events
Total   2/12 (16.67%)    
Psychiatric disorders   
Clinical worsening - behavioral outburst and suicide threats   1/12 (8.33%)  1
Suicide  [1]  1/12 (8.33%)  1
Indicates events were collected by systematic assessment
[1]
Subject died by suicide 10 weeks after being withdrawn from the study.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ketamine Infusion
Affected / at Risk (%) # Events
Total   12/12 (100.00%)    
Blood and lymphatic system disorders   
Transient increases in systolic blood pressure   12/12 (100.00%)  12
Transient increases in diastolic blood pressue   12/12 (100.00%)  12
General disorders   
Dizziness   7/12 (58.33%)  7
Numbness or tingling in extremities   7/12 (58.33%)  7
Sleepiness or sedation   6/12 (50.00%)  6
Nervous system disorders   
Facial numbness   3/12 (25.00%)  3
Psychiatric disorders   
Dissociation   9/12 (75.00%)  9
tearfulness/emotionality   4/12 (33.33%)  4
Indicates events were collected by systematic assessment
Lack of placebo or other control group and small sample size.
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: William V. Bobo, M.D.
Organization: Mayo Clinic
Phone: 507-538-9041
EMail: Bobo.William@mayo.edu
Layout table for additonal information
Responsible Party: William V. Bobo, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT02094898     History of Changes
Other Study ID Numbers: 13-005152
First Submitted: March 10, 2014
First Posted: March 24, 2014
Results First Submitted: May 3, 2017
Results First Posted: August 11, 2017
Last Update Posted: August 11, 2017