Trial Outcomes & Findings for Ketamine as a Treatment for Post-Traumatic Stress Disorder (PTSD) (NCT NCT02397889)
NCT ID: NCT02397889
Last Updated: 2021-03-11
Results Overview
full range score from 0-80, with higher scores indicating greater PTSD symptoms
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
30 participants
Primary outcome timeframe
2 weeks after the first infusion
Results posted on
2021-03-11
Participant Flow
Participant milestones
| Measure |
Experimental Ketamine Group
0.5mg/kg repeated dose ketamine (6 infusions, 3 per week for 2 weeks).
|
Active Control Midazolam Group
0.045mg/kg repeated dose midazolam (6 infusions, 3 per week for 2 weeks).
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Experimental Ketamine Group
0.5mg/kg repeated dose ketamine (6 infusions, 3 per week for 2 weeks).
|
Active Control Midazolam Group
0.045mg/kg repeated dose midazolam (6 infusions, 3 per week for 2 weeks).
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Ketamine as a Treatment for Post-Traumatic Stress Disorder (PTSD)
Baseline characteristics by cohort
| Measure |
Experimental Ketamine Group
n=15 Participants
0.5mg/kg repeated dose ketamine (6 infusions, 3 per week for 2 weeks).
|
Active Control Midazolam Group
n=15 Participants
0.045mg/kg repeated dose midazolam (6 infusions, 3 per week for 2 weeks).
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.3 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
38.5 years
STANDARD_DEVIATION 13.0 • n=7 Participants
|
38.9 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
Sex/Gender, Customized
Females
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Males
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Current treatment with psychotropic medication
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Clinician Administered PTSD Scale (CAPS-5) score
|
41.9 units on a scale
STANDARD_DEVIATION 6.1 • n=5 Participants
|
40.1 units on a scale
STANDARD_DEVIATION 5.9 • n=7 Participants
|
40.9 units on a scale
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
The Impact of Events Scale - Revised (IES-R)
|
41.4 units on a scale
STANDARD_DEVIATION 14.0 • n=5 Participants
|
48.3 units on a scale
STANDARD_DEVIATION 20.1 • n=7 Participants
|
44.8 units on a scale
STANDARD_DEVIATION 17.3 • n=5 Participants
|
|
Montgomery Asberg Depression Rating Scale (MADRS) score
|
26.4 units on a scale
STANDARD_DEVIATION 6.6 • n=5 Participants
|
25.3 units on a scale
STANDARD_DEVIATION 9.0 • n=7 Participants
|
25.8 units on a scale
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Duration of PTSD
|
15.1 years
STANDARD_DEVIATION 17.8 • n=5 Participants
|
14.6 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
14.9 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeks after the first infusionfull range score from 0-80, with higher scores indicating greater PTSD symptoms
Outcome measures
| Measure |
Experimental Ketamine Group
n=15 Participants
0.5mg/kg repeated dose ketamine (6 infusions, 3 per week for 2 weeks).
|
Active Control Midazolam Group
n=15 Participants
0.045mg/kg repeated dose midazolam (6 infusions, 3 per week for 2 weeks).
|
|---|---|---|
|
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
|
22.5 score on a scale
Standard Deviation 14.4
|
33.2 score on a scale
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: 24 hours after the first drug infusionfull range score from 0-88, with higher scores indicating greater PTSD symptoms
Outcome measures
| Measure |
Experimental Ketamine Group
n=15 Participants
0.5mg/kg repeated dose ketamine (6 infusions, 3 per week for 2 weeks).
|
Active Control Midazolam Group
n=15 Participants
0.045mg/kg repeated dose midazolam (6 infusions, 3 per week for 2 weeks).
|
|---|---|---|
|
The Impact of Event Scale - Revised (IES-R)
|
19.7 score on a scale
Standard Deviation 15.2
|
24.8 score on a scale
Standard Deviation 13.1
|
SECONDARY outcome
Timeframe: 24 hours after the first drug infusionfull range score from 0-60, with higher scores indicating greater depressive symptoms
Outcome measures
| Measure |
Experimental Ketamine Group
n=15 Participants
0.5mg/kg repeated dose ketamine (6 infusions, 3 per week for 2 weeks).
|
Active Control Midazolam Group
n=15 Participants
0.045mg/kg repeated dose midazolam (6 infusions, 3 per week for 2 weeks).
|
|---|---|---|
|
Montgomery Asberg Depression Rating Scale (MADRS)
|
16.5 score on a scale
Standard Deviation 9.6
|
17.1 score on a scale
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: 2 weeks after the first drug infusionfull range score from 0-60, with higher scores indicating greater depressive symptoms
Outcome measures
| Measure |
Experimental Ketamine Group
n=15 Participants
0.5mg/kg repeated dose ketamine (6 infusions, 3 per week for 2 weeks).
|
Active Control Midazolam Group
n=15 Participants
0.045mg/kg repeated dose midazolam (6 infusions, 3 per week for 2 weeks).
|
|---|---|---|
|
Montgomery Asberg Depression Rating Scale (MADRS)
|
14.7 score on a scale
Standard Deviation 12.1
|
21.9 score on a scale
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: 2 weeks after the first drug infusionfull range score from 0-27, with higher scores indicating greater depressive symptoms
Outcome measures
| Measure |
Experimental Ketamine Group
n=15 Participants
0.5mg/kg repeated dose ketamine (6 infusions, 3 per week for 2 weeks).
|
Active Control Midazolam Group
n=15 Participants
0.045mg/kg repeated dose midazolam (6 infusions, 3 per week for 2 weeks).
|
|---|---|---|
|
Quick Inventory of Depression Symptomatology - Self-Report (QIDS-SR)
|
6.6 score on a scale
Standard Deviation 7.1
|
6.7 score on a scale
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: up to 21 weeksAll side effects listed in Adverse Event section.
Outcome measures
| Measure |
Experimental Ketamine Group
n=15 Participants
0.5mg/kg repeated dose ketamine (6 infusions, 3 per week for 2 weeks).
|
Active Control Midazolam Group
n=15 Participants
0.045mg/kg repeated dose midazolam (6 infusions, 3 per week for 2 weeks).
|
|---|---|---|
|
Number of Participants With Patient-Rated Inventory of Side Effects (PRISE)
|
15 Participants
|
15 Participants
|
Adverse Events
Experimental Ketamine Group
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Active Control Midazolam Group
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental Ketamine Group
n=15 participants at risk
0.5mg/kg repeated dose ketamine (6 infusions, 3 per week for 2 weeks).
|
Active Control Midazolam Group
n=15 participants at risk
0.045mg/kg repeated dose midazolam (6 infusions, 3 per week for 2 weeks).
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
3/15 • up to 21 weeks
|
26.7%
4/15 • up to 21 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
13.3%
2/15 • up to 21 weeks
|
0.00%
0/15 • up to 21 weeks
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
46.7%
7/15 • up to 21 weeks
|
40.0%
6/15 • up to 21 weeks
|
|
Cardiac disorders
Palpitation
|
6.7%
1/15 • up to 21 weeks
|
6.7%
1/15 • up to 21 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • up to 21 weeks
|
0.00%
0/15 • up to 21 weeks
|
|
Skin and subcutaneous tissue disorders
Increased persipiration
|
6.7%
1/15 • up to 21 weeks
|
0.00%
0/15 • up to 21 weeks
|
|
Skin and subcutaneous tissue disorders
Itching
|
0.00%
0/15 • up to 21 weeks
|
6.7%
1/15 • up to 21 weeks
|
|
Nervous system disorders
Headache
|
46.7%
7/15 • up to 21 weeks
|
40.0%
6/15 • up to 21 weeks
|
|
Nervous system disorders
Tremors
|
0.00%
0/15 • up to 21 weeks
|
6.7%
1/15 • up to 21 weeks
|
|
Nervous system disorders
Dizziness
|
40.0%
6/15 • up to 21 weeks
|
13.3%
2/15 • up to 21 weeks
|
|
Eye disorders
Blurred vision
|
66.7%
10/15 • up to 21 weeks
|
0.00%
0/15 • up to 21 weeks
|
|
Renal and urinary disorders
Difficulty urinating
|
6.7%
1/15 • up to 21 weeks
|
6.7%
1/15 • up to 21 weeks
|
|
Renal and urinary disorders
Painful urination
|
0.00%
0/15 • up to 21 weeks
|
6.7%
1/15 • up to 21 weeks
|
|
Renal and urinary disorders
Frequent urination
|
6.7%
1/15 • up to 21 weeks
|
0.00%
0/15 • up to 21 weeks
|
|
General disorders
Difficulty sleeping
|
13.3%
2/15 • up to 21 weeks
|
0.00%
0/15 • up to 21 weeks
|
|
General disorders
Sleeping too much
|
6.7%
1/15 • up to 21 weeks
|
0.00%
0/15 • up to 21 weeks
|
|
Reproductive system and breast disorders
Loss of sexual desire
|
6.7%
1/15 • up to 21 weeks
|
0.00%
0/15 • up to 21 weeks
|
|
Reproductive system and breast disorders
Trouble achieving orgasm
|
6.7%
1/15 • up to 21 weeks
|
0.00%
0/15 • up to 21 weeks
|
|
General disorders
Anxiety
|
6.7%
1/15 • up to 21 weeks
|
0.00%
0/15 • up to 21 weeks
|
|
General disorders
Poor concentration
|
26.7%
4/15 • up to 21 weeks
|
6.7%
1/15 • up to 21 weeks
|
|
General disorders
Fatigue
|
46.7%
7/15 • up to 21 weeks
|
93.3%
14/15 • up to 21 weeks
|
|
General disorders
Decreased energy
|
6.7%
1/15 • up to 21 weeks
|
6.7%
1/15 • up to 21 weeks
|
|
General disorders
Other
|
100.0%
15/15 • up to 21 weeks
|
66.7%
10/15 • up to 21 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place