Trial Outcomes & Findings for Ketamine For Suicidal Ideation (NCT NCT01507181)
NCT ID: NCT01507181
Last Updated: 2017-02-08
Results Overview
Change in BSI score at 24 hours following treatment as compared to baseline. Beck Scale is a 21-item self or clinician administered instrumentation used to measure the current intensity of patients' specific attitudes, behaviors and plans to commit suicide. Score range 0-42, with higher score indicating higher intensity.
COMPLETED
PHASE4
24 participants
baseline and 24 hours post infusion
2017-02-08
Participant Flow
Participants were recruited through the inpatient psychiatric service or through an academic outpatient psychiatric clinic. All study treatments were performed at Mount Sinai Hospital between April 2012 and June 2014.
Participant milestones
| Measure |
Ketamine
single dose IV ketamine, .5mg/kg
Ketamine: single dose IV ketamine, .5mg/kg infused over 40 minutes
|
Midazolam
single dose IV midazolam, .45mg/kg
Midazolam: single dose IV midazolam, .45mg/kg infused over 40 minutes
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ketamine For Suicidal Ideation
Baseline characteristics by cohort
| Measure |
Ketamine
n=12 Participants
single dose IV ketamine, .5mg/kg
|
Midazolam
n=12 Participants
single dose IV midazolam, .45mg/kg
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.8 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
39.1 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
42.4 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
Gender
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Gender
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
History of suicide attempt
yes
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
History of suicide attempt
no
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
BSI score, baseline
|
17.5 units on a scale
STANDARD_DEVIATION 7.2 • n=5 Participants
|
17.9 units on a scale
STANDARD_DEVIATION 11.9 • n=7 Participants
|
17.7 units on a scale
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
MADRS score, baseline
|
35.2 units on a scale
STANDARD_DEVIATION 6.1 • n=5 Participants
|
34.3 units on a scale
STANDARD_DEVIATION 4.1 • n=7 Participants
|
34.8 units on a scale
STANDARD_DEVIATION 5.1 • n=5 Participants
|
|
Primary Diagnosis
MDD
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Primary Diagnosis
Bipolar disorder
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Primary Diagnosis
PTSD
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Primary Diagnosis
BPD
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Co-occurring disorders
MDD
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Co-occurring disorders
PTSD
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Co-occurring disorders
BPD
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Co-occurring disorders
Panic disorder
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Co-occurring disorders
SAD
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Co-occurring disorders
OCD
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Co-occurring disorders
GAD
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 24 hours post infusionChange in BSI score at 24 hours following treatment as compared to baseline. Beck Scale is a 21-item self or clinician administered instrumentation used to measure the current intensity of patients' specific attitudes, behaviors and plans to commit suicide. Score range 0-42, with higher score indicating higher intensity.
Outcome measures
| Measure |
Ketamine
n=12 Participants
single dose IV ketamine, .5mg/kg
|
Midazolam
n=12 Participants
single dose IV midazolam, .045mg/kg
|
|---|---|---|
|
Change in Beck Scale for Suicidal Ideation (BSSI)
|
10.8 units on a scale
Standard Deviation 8.5
|
14.0 units on a scale
Standard Deviation 10.2
|
PRIMARY outcome
Timeframe: baseline and 48 hours post infusionChange in BSI score at 48 hours following treatment as compared to baseline. Beck Scale is a 21-item self or clinician administered instrumentation used to measure the current intensity of patients' specific attitudes, behaviors and plans to commit suicide. Score range 0-42, with higher score indicating higher intensity.
Outcome measures
| Measure |
Ketamine
n=12 Participants
single dose IV ketamine, .5mg/kg
|
Midazolam
n=12 Participants
single dose IV midazolam, .045mg/kg
|
|---|---|---|
|
Change in Beck Scale for Suicidal Ideation (BSSI)
|
8.8 units on a scale
Standard Deviation 8.3
|
15.3 units on a scale
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: up to 7 days post infusionThe MADRS is a 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.
Outcome measures
| Measure |
Ketamine
n=12 Participants
single dose IV ketamine, .5mg/kg
|
Midazolam
n=12 Participants
single dose IV midazolam, .045mg/kg
|
|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
24 hours
|
19.0 units on a scale
Standard Deviation 15.5
|
26.2 units on a scale
Standard Deviation 10.8
|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
48 hours
|
19.3 units on a scale
Standard Deviation 13.5
|
28 units on a scale
Standard Deviation 12.3
|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
72 hours
|
20.9 units on a scale
Standard Deviation 14.5
|
24.1 units on a scale
Standard Deviation 12.2
|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
7 days
|
21.7 units on a scale
Standard Deviation 13.1
|
22.2 units on a scale
Standard Deviation 13.1
|
SECONDARY outcome
Timeframe: 24 hours post infusionThe MADRS-SI ranges from 0 to 6; a score of 2 corresponds to fleeting, passive SI; a score of 4 indicates that SI is frequent with at least moderate intensity but without specific plans or intention; a score of 6 corresponds to active intention and planning for suicide.
Outcome measures
| Measure |
Ketamine
n=12 Participants
single dose IV ketamine, .5mg/kg
|
Midazolam
n=12 Participants
single dose IV midazolam, .045mg/kg
|
|---|---|---|
|
Suicidality Item of the MADRS (MADRS-SI)
|
1.8 units on a scale
Standard Deviation 1.9
|
3.3 units on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: baseline, 40 minutes post infusion, 240 minutes post infusionAn 11-item questionnaire, used to assess manic symptoms based on the patient's subjective report of his or her clinical condition. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. The scores from each question are added together to form a total score ranging from 0 to 60, with higher scores indicating a greater severity of symptoms.
Outcome measures
| Measure |
Ketamine
n=12 Participants
single dose IV ketamine, .5mg/kg
|
Midazolam
n=12 Participants
single dose IV midazolam, .045mg/kg
|
|---|---|---|
|
The Young Mania Rating Scale (YMRS)
baseline
|
0.0 units on a scale
Standard Deviation 0.0
|
0.1 units on a scale
Standard Deviation 0.3
|
|
The Young Mania Rating Scale (YMRS)
40 minutes post infusion
|
0.0 units on a scale
Standard Deviation 0.0
|
0.3 units on a scale
Standard Deviation 0.6
|
|
The Young Mania Rating Scale (YMRS)
240 minutes post infusion
|
0.2 units on a scale
Standard Deviation 0.6
|
0.2 units on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: baseline, 40 minutes post infusion, and 240 minutes post infusionThe BPRS measures psychomimetic effects with higher scores indicating more severe symptoms (scale range 7 - 49).
Outcome measures
| Measure |
Ketamine
n=12 Participants
single dose IV ketamine, .5mg/kg
|
Midazolam
n=12 Participants
single dose IV midazolam, .045mg/kg
|
|---|---|---|
|
The Brief Psychiatric Rating Scale (BPRS)
baseline
|
7.7 units on a scale
Standard Deviation 1.12
|
7.7 units on a scale
Standard Deviation 1.3
|
|
The Brief Psychiatric Rating Scale (BPRS)
40 minutes post infusion
|
9.9 units on a scale
Standard Deviation 3.3
|
7.9 units on a scale
Standard Deviation 1.8
|
|
The Brief Psychiatric Rating Scale (BPRS)
240 minutes post infusion
|
8.1 units on a scale
Standard Deviation 1.6
|
7.0 units on a scale
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: baseline, 40 minutes post infusion and 240 minutes post infusionThe CADSS measures dissociation with higher scores indicating more severe symptoms (scale range 0 - 92).
Outcome measures
| Measure |
Ketamine
n=12 Participants
single dose IV ketamine, .5mg/kg
|
Midazolam
n=12 Participants
single dose IV midazolam, .045mg/kg
|
|---|---|---|
|
The Clinician-Administered Dissociative States Scale (CADSS)
40 minutes post infusion
|
17.1 units on a scale
Standard Deviation 19.9
|
3.3 units on a scale
Standard Deviation 3.1
|
|
The Clinician-Administered Dissociative States Scale (CADSS)
240 minutes post infusion
|
1.2 units on a scale
Standard Deviation 1.9
|
1.3 units on a scale
Standard Deviation 2.6
|
|
The Clinician-Administered Dissociative States Scale (CADSS)
baseline
|
1.1 units on a scale
Standard Deviation 2.6
|
4.0 units on a scale
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: duration of studyThe PRISE assesses the presence of treatment side effects in nine organ/function systems (gastrointestinal, nervous system, heart, eyes/ears, skin, genital/urinary, sleep, sexual functioning, and other). Data reported in in Adverse Events section.
Outcome measures
| Measure |
Ketamine
n=12 Participants
single dose IV ketamine, .5mg/kg
|
Midazolam
n=12 Participants
single dose IV midazolam, .045mg/kg
|
|---|---|---|
|
Patient Rated Inventory of Side Effects (PRISE)
|
29 events
|
23 events
|
Adverse Events
Ketamine
Midazolam
Serious adverse events
| Measure |
Ketamine
n=12 participants at risk
single dose IV ketamine, .5mg/kg
|
Midazolam
n=12 participants at risk
single dose IV midazolam, .45mg/kg
|
|---|---|---|
|
Psychiatric disorders
Hospitalizations
|
33.3%
4/12
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Death
|
8.3%
1/12
|
0.00%
0/12
|
Other adverse events
| Measure |
Ketamine
n=12 participants at risk
single dose IV ketamine, .5mg/kg
|
Midazolam
n=12 participants at risk
single dose IV midazolam, .45mg/kg
|
|---|---|---|
|
Nervous system disorders
Headache
|
58.3%
7/12 • Number of events 7
|
25.0%
3/12 • Number of events 3
|
|
Nervous system disorders
Dizziness on standing
|
16.7%
2/12 • Number of events 2
|
25.0%
3/12 • Number of events 3
|
|
General disorders
Nausea/Vomiting
|
8.3%
1/12 • Number of events 1
|
25.0%
3/12 • Number of events 3
|
|
General disorders
Diarrhea
|
0.00%
0/12
|
25.0%
3/12 • Number of events 3
|
|
Psychiatric disorders
Anxiety
|
16.7%
2/12 • Number of events 2
|
16.7%
2/12 • Number of events 2
|
|
General disorders
Poor concentration
|
16.7%
2/12 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Poor coordination
|
16.7%
2/12 • Number of events 2
|
0.00%
0/12
|
|
General disorders
General malaise
|
16.7%
2/12 • Number of events 2
|
0.00%
0/12
|
|
General disorders
Restlessness
|
16.7%
2/12 • Number of events 2
|
0.00%
0/12
|
|
General disorders
Dry mouth
|
0.00%
0/12
|
16.7%
2/12 • Number of events 2
|
|
Cardiac disorders
Chest pain
|
0.00%
0/12
|
16.7%
2/12 • Number of events 2
|
|
Eye disorders
Blurred vision
|
8.3%
1/12 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Renal and urinary disorders
Frequent urination
|
8.3%
1/12 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Difficulty sleeping
|
8.3%
1/12 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
Additional Information
Dr. J. W. Murrough
Mood and Anxiety Disorders Program, Department of Psychiatry, Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place