Trial Outcomes & Findings for Ketamine in the Treatment of Suicidal Depression (NCT NCT01700829)
NCT ID: NCT01700829
Last Updated: 2020-03-11
Results Overview
Change in suicidal ideation in depressed patients with moderate to severe suicidal thoughts from the pre-infusion baseline to 24 hours after the infusion with ketamine or midazolam, a sedative not known to reduce suicidal ideation, measured with Beck Scale for Suicidal Ideation - clinician rated version. This scale has 19 items scaled 0 (least severe) to 2 (most severe) and a potential score ranging from 0 to 38, with higher score indicating greater severity.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
82 participants
Primary outcome timeframe
Day 1 (24 hours) post-treatment
Results posted on
2020-03-11
Participant Flow
Participant milestones
| Measure |
Midazolam
0.02 mg/kg, I.V. (in the vein)
Midazolam: Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes
|
Ketamine
0.5 mg/kg, I.V. (in the vein)
Ketamine: Single dose of 0.5 mg/kg of ketamine given intravenously (in the vein) over 40 minutes
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
41
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Midazolam
0.02 mg/kg, I.V. (in the vein)
Midazolam: Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes
|
Ketamine
0.5 mg/kg, I.V. (in the vein)
Ketamine: Single dose of 0.5 mg/kg of ketamine given intravenously (in the vein) over 40 minutes
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Ketamine in the Treatment of Suicidal Depression
Baseline characteristics by cohort
| Measure |
Midazolam
n=40 Participants
0.02 mg/kg, I.V. (in the vein)
Midazolam: Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes
|
Ketamine
n=40 Participants
0.5 mg/kg, I.V. (in the vein)
Ketamine: Single dose of 0.5 mg/kg of ketamine given intravenously (in the vein) over 40 minutes
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.7 years
STANDARD_DEVIATION 13.1 • n=93 Participants
|
38.4 years
STANDARD_DEVIATION 13.2 • n=4 Participants
|
39.5 years
STANDARD_DEVIATION 13.1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
79 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
74 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=93 Participants
|
40 participants
n=4 Participants
|
80 participants
n=27 Participants
|
|
Scale for Suicidal Ideation
|
15.7 units on a scale
STANDARD_DEVIATION 6.9 • n=93 Participants
|
14.3 units on a scale
STANDARD_DEVIATION 6.3 • n=4 Participants
|
14.98 units on a scale
STANDARD_DEVIATION 6.6 • n=27 Participants
|
PRIMARY outcome
Timeframe: Day 1 (24 hours) post-treatmentChange in suicidal ideation in depressed patients with moderate to severe suicidal thoughts from the pre-infusion baseline to 24 hours after the infusion with ketamine or midazolam, a sedative not known to reduce suicidal ideation, measured with Beck Scale for Suicidal Ideation - clinician rated version. This scale has 19 items scaled 0 (least severe) to 2 (most severe) and a potential score ranging from 0 to 38, with higher score indicating greater severity.
Outcome measures
| Measure |
Midazolam
n=40 Participants
Midazolam: Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes
|
Ketamine
n=40 Participants
Ketamine: Single dose of 0.5 mg/kg of ketamine given intravenously (in the vein) over 40 minutes
|
|---|---|---|
|
Change in Scale for Suicidal Ideation
|
-3.66 units on a scale
Standard Error 0.93
|
-8.62 units on a scale
Standard Error 0.93
|
SECONDARY outcome
Timeframe: Cort2 - Cort1 = (Day 1 30-mins post-awakening cortisol) - (Day 1 awakening cortisol)On the mornings of an infusion day and on post-treatment day1, participants used salivettes (Sarstedt AG \& Co.) to provide saliva samples upon awakening (Cort1) and 30 minutes later (Cort2) to measure cortisol awakening response (CAR) = (Cort2 - Cort1). Differences between the midazolam and ketamine groups were tested using an analysis of covariance (ANCOVA) model of the change in CAR from baseline to day1, with treatment group and baseline measurement of the outcome variable as predictors. Range from 0.1 to 12.5 ng/ml and lower means less stress response, higher means greater stress response.
Outcome measures
| Measure |
Midazolam
n=40 Participants
Midazolam: Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes
|
Ketamine
n=40 Participants
Ketamine: Single dose of 0.5 mg/kg of ketamine given intravenously (in the vein) over 40 minutes
|
|---|---|---|
|
Saliva Cortisol Awakening Response (CAR).
Baseline awakening
|
0.94 log(ng/mL)
Standard Deviation 0.61
|
0.47 log(ng/mL)
Standard Deviation 1.16
|
|
Saliva Cortisol Awakening Response (CAR).
Baseline 30 mins post-awakening
|
1.29 log(ng/mL)
Standard Deviation 0.53
|
0.88 log(ng/mL)
Standard Deviation 1.17
|
|
Saliva Cortisol Awakening Response (CAR).
Day1 awakening
|
0.77 log(ng/mL)
Standard Deviation 0.76
|
0.74 log(ng/mL)
Standard Deviation 0.88
|
|
Saliva Cortisol Awakening Response (CAR).
Day1 30 minutes post-awakening
|
1.19 log(ng/mL)
Standard Deviation 0.74
|
1.06 log(ng/mL)
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: Baseline and Day 1The average Z-scores reported below are the average of the Z-scores for all tests administered. The Z-scores for each test were based on published normative data and normative data available in our laboratory. The population mean for a Z-score is zero, with a SD of 1, thus scores below zero would indicate performance below the population norm; a score close to zero indicates performance close to the population norm (or a normalizing of performance).
Outcome measures
| Measure |
Midazolam
n=40 Participants
Midazolam: Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes
|
Ketamine
n=40 Participants
Ketamine: Single dose of 0.5 mg/kg of ketamine given intravenously (in the vein) over 40 minutes
|
|---|---|---|
|
Neuropsychological Effects
Pre-infusion overall neuropsych performance
|
-0.252 score on a scale
Standard Error 0.096
|
-0.306 score on a scale
Standard Error 0.096
|
|
Neuropsychological Effects
Day1 post-infusion overall neuropsych performance
|
-0.146 score on a scale
Standard Error 0.106
|
-0.01 score on a scale
Standard Error 0.106
|
Adverse Events
Midazolam
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Ketamine
Serious events: 5 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Midazolam
n=40 participants at risk
0.02 mg/kg, I.V. (in the vein)
Midazolam: Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes
|
Ketamine
n=40 participants at risk
0.5 mg/kg, I.V. (in the vein)
Ketamine: Single dose of 0.5 mg/kg of ketamine given intravenously (in the vein) over 40 minutes
|
|---|---|---|
|
General disorders
Inpatient admission for suicidal ideation
|
5.0%
2/40 • Number of events 2 • Adverse event data were collected for the 24 hour primary outcome study period.
For the other (not including serious) adverse events, the total numbers without specific types, are reported here, with further detail available in the published paper.
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected for the 24 hour primary outcome study period.
For the other (not including serious) adverse events, the total numbers without specific types, are reported here, with further detail available in the published paper.
|
|
General disorders
overdose
|
5.0%
2/40 • Number of events 2 • Adverse event data were collected for the 24 hour primary outcome study period.
For the other (not including serious) adverse events, the total numbers without specific types, are reported here, with further detail available in the published paper.
|
7.5%
3/40 • Number of events 3 • Adverse event data were collected for the 24 hour primary outcome study period.
For the other (not including serious) adverse events, the total numbers without specific types, are reported here, with further detail available in the published paper.
|
|
Gastrointestinal disorders
medical illness unrelated to study
|
0.00%
0/40 • Adverse event data were collected for the 24 hour primary outcome study period.
For the other (not including serious) adverse events, the total numbers without specific types, are reported here, with further detail available in the published paper.
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected for the 24 hour primary outcome study period.
For the other (not including serious) adverse events, the total numbers without specific types, are reported here, with further detail available in the published paper.
|
Other adverse events
| Measure |
Midazolam
n=40 participants at risk
0.02 mg/kg, I.V. (in the vein)
Midazolam: Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes
|
Ketamine
n=40 participants at risk
0.5 mg/kg, I.V. (in the vein)
Ketamine: Single dose of 0.5 mg/kg of ketamine given intravenously (in the vein) over 40 minutes
|
|---|---|---|
|
General disorders
Subjects with any event
|
30.0%
12/40 • Number of events 13 • Adverse event data were collected for the 24 hour primary outcome study period.
For the other (not including serious) adverse events, the total numbers without specific types, are reported here, with further detail available in the published paper.
|
25.0%
10/40 • Number of events 11 • Adverse event data were collected for the 24 hour primary outcome study period.
For the other (not including serious) adverse events, the total numbers without specific types, are reported here, with further detail available in the published paper.
|
Additional Information
Michael Grunebaum, MD
NY State Psychiatric Institute-Columbia University Medical Center
Phone: 646-774-7573
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place