Trial Outcomes & Findings for Ketamine as a Rapid Treatment for Post-traumatic Stress Disorder (PTSD) (NCT NCT00749203)
NCT ID: NCT00749203
Last Updated: 2018-02-14
Results Overview
A 22-item self-report questionnaire measuring PTSD symptoms. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score ranging from 0 (not at all) to 88 (extremely)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
7 days after first infusion
Results posted on
2018-02-14
Participant Flow
Patients with chronic PTSD related to a range of trauma exposures were recruited via advertisements beginning Jan 2009, and were enrolled at the Icahn School of Medicine at Mount Sinai, New York, between May 2009 and December 2012.
Participant milestones
| Measure |
Ketamine Then Midazolam
Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes on day 1,
then 2 weeks later, Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes
|
Midazolam Then Ketamine
Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes on day 1, then 2 weeks later, Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes
|
|---|---|---|
|
First Infusion Day 1
STARTED
|
22
|
19
|
|
First Infusion Day 1
COMPLETED
|
22
|
19
|
|
First Infusion Day 1
NOT COMPLETED
|
0
|
0
|
|
no Infusion at Week 1
STARTED
|
22
|
19
|
|
no Infusion at Week 1
COMPLETED
|
22
|
15
|
|
no Infusion at Week 1
NOT COMPLETED
|
0
|
4
|
|
Second Infusion at 2 Weeks
STARTED
|
16
|
15
|
|
Second Infusion at 2 Weeks
COMPLETED
|
16
|
13
|
|
Second Infusion at 2 Weeks
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Ketamine Then Midazolam
Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes on day 1,
then 2 weeks later, Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes
|
Midazolam Then Ketamine
Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes on day 1, then 2 weeks later, Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes
|
|---|---|---|
|
no Infusion at Week 1
Lost to Follow-up
|
0
|
1
|
|
no Infusion at Week 1
Withdrawal by Subject
|
0
|
1
|
|
no Infusion at Week 1
delayed-onset sedation
|
0
|
1
|
|
no Infusion at Week 1
low baseline PTSD symptoms level
|
0
|
1
|
|
Second Infusion at 2 Weeks
Protocol Violation
|
0
|
1
|
|
Second Infusion at 2 Weeks
pt felt uncomfortable after infusion
|
0
|
1
|
Baseline Characteristics
Ketamine as a Rapid Treatment for Post-traumatic Stress Disorder (PTSD)
Baseline characteristics by cohort
| Measure |
Ketamine Then Midazolam
n=22 Participants
Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes on Day 1, then 2 weeks later, Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes
|
Midazolam the Ketamine
n=19 Participants
Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes on Day 1, then 2 weeks later Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.4 years
STANDARD_DEVIATION 10.8 • n=93 Participants
|
35.7 years
STANDARD_DEVIATION 10.0 • n=4 Participants
|
36.05 years
STANDARD_DEVIATION 10.3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
22 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
|
0 Participants
n=4 Participants
|
0 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
|
11 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
7 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
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Education
less than high school
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Education
high school graduate
|
3 participants
n=93 Participants
|
3 participants
n=4 Participants
|
6 participants
n=27 Participants
|
|
Education
some college
|
12 participants
n=93 Participants
|
14 participants
n=4 Participants
|
26 participants
n=27 Participants
|
|
Education
more than 4 years of college
|
5 participants
n=93 Participants
|
2 participants
n=4 Participants
|
7 participants
n=27 Participants
|
|
Education
unknown
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Percentage Unemployed
|
50 percentage of participants
n=93 Participants
|
73.7 percentage of participants
n=4 Participants
|
123.7 percentage of participants
n=27 Participants
|
|
Primary Trauma
Sexual assault or molestation
|
9 participants
n=93 Participants
|
0 participants
n=4 Participants
|
9 participants
n=27 Participants
|
|
Primary Trauma
Physical assault or abuse
|
4 participants
n=93 Participants
|
7 participants
n=4 Participants
|
11 participants
n=27 Participants
|
|
Primary Trauma
Accident or fire
|
1 participants
n=93 Participants
|
3 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Primary Trauma
Combat exposure
|
2 participants
n=93 Participants
|
0 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Primary Trauma
Witnessed violent assault or death
|
4 participants
n=93 Participants
|
5 participants
n=4 Participants
|
9 participants
n=27 Participants
|
|
Primary Trauma
Witnessed 9/11 terrorist attacks
|
2 participants
n=93 Participants
|
0 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Primary Trauma
Unknown
|
0 participants
n=93 Participants
|
4 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Duration of PTSD
|
14.2 years
STANDARD_DEVIATION 12.3 • n=93 Participants
|
11.9 years
STANDARD_DEVIATION 14.0 • n=4 Participants
|
13.1 years
STANDARD_DEVIATION 13.1 • n=27 Participants
|
|
History of treatment with psychotropic medication
|
50 percentage of participants
n=93 Participants
|
42.1 percentage of participants
n=4 Participants
|
92.1 percentage of participants
n=27 Participants
|
|
Clinician-Administered PTSD Scale (CAPS) score (past month)
|
82.5 units on a scale
STANDARD_DEVIATION 14.1 • n=93 Participants
|
77.1 units on a scale
STANDARD_DEVIATION 11.8 • n=4 Participants
|
80.0 units on a scale
STANDARD_DEVIATION 13.0 • n=27 Participants
|
|
Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) score
|
12.4 units on a scale
STANDARD_DEVIATION 5.2 • n=93 Participants
|
11.3 units on a scale
STANDARD_DEVIATION 5.6 • n=4 Participants
|
11.9 units on a scale
STANDARD_DEVIATION 5.4 • n=27 Participants
|
PRIMARY outcome
Timeframe: 7 days after first infusionPopulation: Not all participants returned for the 1 week follow up visit. There were 19 participants from the Ketamine group and 15 participants from the Midazolam group who returned for their followup visit and completed the IES-R at the 1 week follow up visit.
A 22-item self-report questionnaire measuring PTSD symptoms. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score ranging from 0 (not at all) to 88 (extremely)
Outcome measures
| Measure |
Ketamine
n=19 Participants
Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes
Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes
|
Midazolam
n=15 Participants
single dose 0.045 mg/kg IV infused over 40 minutes
Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes
|
|---|---|---|
|
Impact of Event Scale - Revised (IES-R)
|
25.76 units on a scale
Standard Deviation 19.4
|
36.32 units on a scale
Standard Deviation 13.73
|
SECONDARY outcome
Timeframe: 7 days after first infusionPopulation: Not all participants returned for the 1 week follow up visit. There were 19 participants from the Ketamine group and 15 participants from the Midazolam group who returned for their followup visit and completed the IES-R at the 1 week follow up visit.
Clinician-administered structured interview measuring PTSD symptoms. frequency score - scale 0 = none of the time to 4 = most or all of the time intensity score - scale 0 = none to 4 = extreme To meet criteria for a symptom, a patient must meet criteria in both frequency and intensity score for each item. Frequency and intensity and then combined to form a single severity score. 30 questions scale, with total score ranging from 0 to 240.
Outcome measures
| Measure |
Ketamine
n=19 Participants
Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes
Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes
|
Midazolam
n=15 Participants
single dose 0.045 mg/kg IV infused over 40 minutes
Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes
|
|---|---|---|
|
Clinician-Administered PTSD Scale (CAPS)
|
54 units on a scale
Standard Deviation 23.63
|
65.69 units on a scale
Standard Deviation 16.36
|
SECONDARY outcome
Timeframe: 24 hours after first infusionSelf-report questionnaire measuring depressive symptoms. Each item is rated 0 (no depression) to 3 (severe depression). The total score ranges from 0-27.
Outcome measures
| Measure |
Ketamine
n=22 Participants
Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes
Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes
|
Midazolam
n=19 Participants
single dose 0.045 mg/kg IV infused over 40 minutes
Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes
|
|---|---|---|
|
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
|
12.4 units on a scale
Standard Deviation 5.2
|
11.3 units on a scale
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: 24 hours after first infusionClinician-administered questionnaire measuring depressive symptoms. The MADRS-S has 10-items which are based on mood symptoms over the past 7 days. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression). Mean difference between baseline and 2 weeks.
Outcome measures
| Measure |
Ketamine
n=22 Participants
Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes
Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes
|
Midazolam
n=19 Participants
single dose 0.045 mg/kg IV infused over 40 minutes
Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes
|
|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
|
12.6 units on a scale
Standard Deviation 7.9
|
10.1 units on a scale
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: 20 to 40 minutes after infusionPopulation: data not collected
Repeatable test of memory acquisition and delayed recall of words. It is a three-trial list learning and free recall task comprising 12 words, 4 words from each of three semantic categories. Total Recall score range is 0 to 36.
Outcome measures
Outcome data not reported
Adverse Events
Ketamine
Serious events: 33 serious events
Other events: 0 other events
Deaths: 0 deaths
Midazolam
Serious events: 31 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ketamine
n=38 participants at risk
Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes,
|
Midazolam
n=31 participants at risk
Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
7.9%
3/38 • 24 hours post infusion
|
6.5%
2/31 • 24 hours post infusion
|
|
Gastrointestinal disorders
Dry Mouth
|
26.3%
10/38 • 24 hours post infusion
|
12.9%
4/31 • 24 hours post infusion
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
26.3%
10/38 • 24 hours post infusion
|
0.00%
0/31 • 24 hours post infusion
|
|
Cardiac disorders
Palpitation
|
7.9%
3/38 • 24 hours post infusion
|
0.00%
0/31 • 24 hours post infusion
|
|
Cardiac disorders
Dizziness on standing
|
15.8%
6/38 • 24 hours post infusion
|
16.1%
5/31 • 24 hours post infusion
|
|
Cardiac disorders
Chest Pain
|
5.3%
2/38 • 24 hours post infusion
|
9.7%
3/31 • 24 hours post infusion
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.6%
1/38 • 24 hours post infusion
|
0.00%
0/31 • 24 hours post infusion
|
|
Skin and subcutaneous tissue disorders
Increased perspiration
|
7.9%
3/38 • 24 hours post infusion
|
3.2%
1/31 • 24 hours post infusion
|
|
Skin and subcutaneous tissue disorders
Itching
|
2.6%
1/38 • 24 hours post infusion
|
0.00%
0/31 • 24 hours post infusion
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.3%
2/38 • 24 hours post infusion
|
3.2%
1/31 • 24 hours post infusion
|
|
Nervous system disorders
Headace
|
21.1%
8/38 • 24 hours post infusion
|
12.9%
4/31 • 24 hours post infusion
|
|
Nervous system disorders
Tremors
|
0.00%
0/38 • 24 hours post infusion
|
3.2%
1/31 • 24 hours post infusion
|
|
Nervous system disorders
Poor coordination
|
18.4%
7/38 • 24 hours post infusion
|
3.2%
1/31 • 24 hours post infusion
|
|
Nervous system disorders
Dizziness
|
36.8%
14/38 • 24 hours post infusion
|
29.0%
9/31 • 24 hours post infusion
|
|
Eye disorders
Blurred vision
|
39.5%
15/38 • 24 hours post infusion
|
19.4%
6/31 • 24 hours post infusion
|
|
Ear and labyrinth disorders
Ringing in ears
|
13.2%
5/38 • 24 hours post infusion
|
3.2%
1/31 • 24 hours post infusion
|
|
Renal and urinary disorders
Difficulty urinating
|
0.00%
0/38 • 24 hours post infusion
|
9.7%
3/31 • 24 hours post infusion
|
|
Renal and urinary disorders
Painful urination
|
5.3%
2/38 • 24 hours post infusion
|
3.2%
1/31 • 24 hours post infusion
|
|
Renal and urinary disorders
Frequent urination
|
5.3%
2/38 • 24 hours post infusion
|
12.9%
4/31 • 24 hours post infusion
|
|
General disorders
Difficulty sleeping
|
7.9%
3/38 • 24 hours post infusion
|
9.7%
3/31 • 24 hours post infusion
|
|
General disorders
Sleeping too much
|
5.3%
2/38 • 24 hours post infusion
|
3.2%
1/31 • 24 hours post infusion
|
|
General disorders
Anxiety
|
13.2%
5/38 • 24 hours post infusion
|
3.2%
1/31 • 24 hours post infusion
|
|
General disorders
Poor concentration
|
10.5%
4/38 • 24 hours post infusion
|
19.4%
6/31 • 24 hours post infusion
|
|
General disorders
General malaise
|
7.9%
3/38 • 24 hours post infusion
|
3.2%
1/31 • 24 hours post infusion
|
|
General disorders
Restlessness
|
34.2%
13/38 • 24 hours post infusion
|
12.9%
4/31 • 24 hours post infusion
|
|
General disorders
Fatigue
|
26.3%
10/38 • 24 hours post infusion
|
19.4%
6/31 • 24 hours post infusion
|
|
General disorders
Decreased energy
|
15.8%
6/38 • 24 hours post infusion
|
9.7%
3/31 • 24 hours post infusion
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Adriana Feder
Icahn School of Medicine at Mount Sinai
Phone: 212-241-1563
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place