Trial Outcomes & Findings for Ketamine for Suicidality in Bipolar Depression (NCT NCT01944293)
NCT ID: NCT01944293
Last Updated: 2020-03-11
Results Overview
Change in suicidal ideation in Bipolar Disorder during a Major Depressive Episode (MDE), with moderate to severe suicidal thoughts, from the pre-infusion baseline to 24 hours after the infusion of Ketamine (study drug) or Midazolam (active control).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
16 participants
Primary outcome timeframe
At 24 hours post-Infusion
Results posted on
2020-03-11
Participant Flow
Participant milestones
| Measure |
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
|
Midazolam
0.02 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
Midazolam: Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
9
|
|
Overall Study
COMPLETED
|
7
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ketamine for Suicidality in Bipolar Depression
Baseline characteristics by cohort
| Measure |
Ketamine
n=7 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
|
Midazolam
n=9 Participants
0.02 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
Midazolam: Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39 years
STANDARD_DEVIATION 10.2 • n=93 Participants
|
43 years
STANDARD_DEVIATION 13.9 • n=4 Participants
|
40.5 years
STANDARD_DEVIATION 12.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White race
|
6 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic
|
7 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Beck Scale for Suicidal Ideation (Clinician-rated)
|
16.7 units on a scale
STANDARD_DEVIATION 8.4 • n=93 Participants
|
16.8 units on a scale
STANDARD_DEVIATION 6.0 • n=4 Participants
|
16.8 units on a scale
STANDARD_DEVIATION 6.9 • n=27 Participants
|
PRIMARY outcome
Timeframe: At 24 hours post-InfusionPopulation: Bipolar depression with suicidal ideation.
Change in suicidal ideation in Bipolar Disorder during a Major Depressive Episode (MDE), with moderate to severe suicidal thoughts, from the pre-infusion baseline to 24 hours after the infusion of Ketamine (study drug) or Midazolam (active control).
Outcome measures
| Measure |
Ketamine
n=7 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
|
Midazolam
n=9 Participants
0.02 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
Midazolam: Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes
|
|---|---|---|
|
Change in Suicidal Ideation Measured With the Beck Scale for Suicidal Ideation
|
-12.4 units on a scale
Standard Deviation 11.6
|
-6.7 units on a scale
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: During study infusionBlood pressure is measured in millimeters of mercury.
Outcome measures
| Measure |
Ketamine
n=7 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
|
Midazolam
n=9 Participants
0.02 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
Midazolam: Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes
|
|---|---|---|
|
Change in Systolic Blood Pressure
|
23 mm Hg
Standard Deviation 12.8
|
3 mm Hg
Standard Deviation 10.2
|
Adverse Events
Ketamine
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Midazolam
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ketamine
n=7 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
|
Midazolam
n=9 participants at risk
0.02 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
Midazolam: Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes
|
|---|---|---|
|
Psychiatric disorders
Increased suicidal thoughts requiring hospitalization
|
28.6%
2/7 • Number of events 4 • 6 months
|
0.00%
0/9 • 6 months
|
|
Psychiatric disorders
suicide attempt
|
14.3%
1/7 • Number of events 1 • 6 months
|
0.00%
0/9 • 6 months
|
|
Psychiatric disorders
Preparatory suicidal behavior
|
14.3%
1/7 • Number of events 1 • 6 months
|
0.00%
0/9 • 6 months
|
Other adverse events
Adverse event data not reported
Additional Information
Michael Grunebaum, MD
Columbia University Medical Center - NY State Psychiatric Institute
Phone: 646-774-7573
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place