Trial Outcomes & Findings for CAP-Ketamine for Antidepressant Resistant PTSD (NCT NCT02655692)
NCT ID: NCT02655692
Last Updated: 2022-06-02
Results Overview
The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = "Not at all" to 4 = "Extremely"). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD
COMPLETED
PHASE2
163 participants
Session 1 -Day 0
2022-06-02
Participant Flow
Participant milestones
| Measure |
Placebo
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
Overall Study
STARTED
|
55
|
55
|
53
|
|
Overall Study
COMPLETED
|
36
|
41
|
40
|
|
Overall Study
NOT COMPLETED
|
19
|
14
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CAP-Ketamine for Antidepressant Resistant PTSD
Baseline characteristics by cohort
| Measure |
Placebo
n=54 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=53 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=51 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
Total
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 1.5 • n=99 Participants
|
45 years
STANDARD_DEVIATION 1.5 • n=107 Participants
|
43 years
STANDARD_DEVIATION 1.8 • n=206 Participants
|
43.3 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
37 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
121 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White - non Hispanic
|
37 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
94 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
8 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
31 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
PCL
|
51.95 units on a scale
STANDARD_DEVIATION 10.82 • n=99 Participants
|
51.75 units on a scale
STANDARD_DEVIATION 12.38 • n=107 Participants
|
50.23 units on a scale
STANDARD_DEVIATION 14.69 • n=206 Participants
|
51.33 units on a scale
STANDARD_DEVIATION 12.62 • n=7 Participants
|
PRIMARY outcome
Timeframe: Session 1 -Day 0Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = "Not at all" to 4 = "Extremely"). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD
Outcome measures
| Measure |
Placebo
n=54 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=53 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=51 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
PTSD Checklist (PCL)
|
48.56 units on a scale
Standard Deviation 12.76
|
46.62 units on a scale
Standard Deviation 17.71
|
47.88 units on a scale
Standard Deviation 14.46
|
PRIMARY outcome
Timeframe: Session 2 - Day 1Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = "Not at all" to 4 = "Extremely"). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD
Outcome measures
| Measure |
Placebo
n=52 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=51 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=49 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
The PTSD Checklist (PCL)
|
37.65 units on a scale
Standard Deviation 18.40
|
32.75 units on a scale
Standard Deviation 19.39
|
30.10 units on a scale
Standard Deviation 20.25
|
PRIMARY outcome
Timeframe: Session 3 - Day 3Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = "Not at all" to 4 = "Extremely"). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD
Outcome measures
| Measure |
Placebo
n=51 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=50 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=44 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
The PTSD Checklist (PCL)
|
36.90 units on a scale
Standard Deviation 18.11
|
33.66 units on a scale
Standard Deviation 18.67
|
34.20 units on a scale
Standard Deviation 18.37
|
PRIMARY outcome
Timeframe: Session 4 - Day 7Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = "Not at all" to 4 = "Extremely"). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD
Outcome measures
| Measure |
Placebo
n=48 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=47 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=43 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
The PTSD Checklist (PCL)
|
34.75 units on a scale
Standard Deviation 18.96
|
29.09 units on a scale
Standard Deviation 20.61
|
32.58 units on a scale
Standard Deviation 19.12
|
PRIMARY outcome
Timeframe: Session 5 - Day 10Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = "Not at all" to 4 = "Extremely"). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD
Outcome measures
| Measure |
Placebo
n=47 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=45 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=46 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
The PTSD Checklist (PCL)
|
35.11 units on a scale
Standard Deviation 18.84
|
28.51 units on a scale
Standard Deviation 21.12
|
31.46 units on a scale
Standard Deviation 18.60
|
PRIMARY outcome
Timeframe: Session 6 - Day 14Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = "Not at all" to 4 = "Extremely"). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD
Outcome measures
| Measure |
Placebo
n=44 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=48 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=43 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
The PTSD Checklist (PCL)
|
30.80 units on a scale
Standard Deviation 19.85
|
26.40 units on a scale
Standard Deviation 21.12
|
27.91 units on a scale
Standard Deviation 17.04
|
PRIMARY outcome
Timeframe: Session 7 - Day 17Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = "Not at all" to 4 = "Extremely"). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD
Outcome measures
| Measure |
Placebo
n=44 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=47 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=41 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
The PTSD Checklist (PCL)
|
28.48 units on a scale
Standard Deviation 19.47
|
24.13 units on a scale
Standard Deviation 20.15
|
26.54 units on a scale
Standard Deviation 17.58
|
PRIMARY outcome
Timeframe: Session 8 - Day 21Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = "Not at all" to 4 = "Extremely"). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD
Outcome measures
| Measure |
Placebo
n=42 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=42 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=40 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
The PTSD Checklist (PCL)
|
29.31 units on a scale
Standard Deviation 20.39
|
24.52 units on a scale
Standard Deviation 20.45
|
26.73 units on a scale
Standard Deviation 17.20
|
PRIMARY outcome
Timeframe: Session 9 - Day 24Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = "Not at all" to 4 = "Extremely"). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD
Outcome measures
| Measure |
Placebo
n=45 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=46 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=42 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
The PTSD Checklist (PCL)
|
28.31 units on a scale
Standard Deviation 19.89
|
21.94 units on a scale
Standard Deviation 20.35
|
25.62 units on a scale
Standard Deviation 19.86
|
PRIMARY outcome
Timeframe: Follow-up 1 - Day 25Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = "Not at all" to 4 = "Extremely"). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD
Outcome measures
| Measure |
Placebo
n=44 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=43 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=41 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
The PTSD Checklist (PCL)
|
27.34 units on a scale
Standard Deviation 20.25
|
21.35 units on a scale
Standard Deviation 20.70
|
22.54 units on a scale
Standard Deviation 17.98
|
PRIMARY outcome
Timeframe: Follow-up 2 - Day 28Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = "Not at all" to 4 = "Extremely"). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD
Outcome measures
| Measure |
Placebo
n=25 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=17 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=12 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
The PTSD Checklist (PCL)
|
37.84 units on a scale
Standard Deviation 18.37
|
34.59 units on a scale
Standard Deviation 18.45
|
39.58 units on a scale
Standard Deviation 15.55
|
PRIMARY outcome
Timeframe: Follow-up 3 - Day 29Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = "Not at all" to 4 = "Extremely"). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD
Outcome measures
| Measure |
Placebo
n=24 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=18 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=11 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
The PTSD Checklist (PCL)
|
33.79 units on a scale
Standard Deviation 19.80
|
33.72 units on a scale
Standard Deviation 20.17
|
40.27 units on a scale
Standard Deviation 16.29
|
PRIMARY outcome
Timeframe: Follow-up 4 - Day 35Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = "Not at all" to 4 = "Extremely"). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD
Outcome measures
| Measure |
Placebo
n=38 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=38 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=33 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
The PTSD Checklist (PCL)
|
26.92 units on a scale
Standard Deviation 19.17
|
22.84 units on a scale
Standard Deviation 21.46
|
24.09 units on a scale
Standard Deviation 17.05
|
PRIMARY outcome
Timeframe: Follow-up 5 - Day 42Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = "Not at all" to 4 = "Extremely"). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD
Outcome measures
| Measure |
Placebo
n=35 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=39 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=37 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
The PTSD Checklist (PCL)
|
28.14 units on a scale
Standard Deviation 20.92
|
25.62 units on a scale
Standard Deviation 21.81
|
29.16 units on a scale
Standard Deviation 19.85
|
PRIMARY outcome
Timeframe: Follow-up 6 - Day 49Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = "Not at all" to 4 = "Extremely"). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD
Outcome measures
| Measure |
Placebo
n=35 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=39 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=38 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
The PTSD Checklist (PCL)
|
30.71 units on a scale
Standard Deviation 21.33
|
24.90 units on a scale
Standard Deviation 20.66
|
30.21 units on a scale
Standard Deviation 18.82
|
PRIMARY outcome
Timeframe: Follow-up 7 - Day 56Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = "Not at all" to 4 = "Extremely"). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD
Outcome measures
| Measure |
Placebo
n=39 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=41 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=35 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
The PTSD Checklist (PCL)
|
31.90 units on a scale
Standard Deviation 21.08
|
24.32 units on a scale
Standard Deviation 21.15
|
31.23 units on a scale
Standard Deviation 19.81
|
SECONDARY outcome
Timeframe: Session 1 - Day 0Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \>34 - severe depression)
Outcome measures
| Measure |
Placebo
n=54 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=52 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=51 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
|
28.24 score on a scale
Standard Deviation 8.43
|
27.81 score on a scale
Standard Deviation 10.30
|
27.84 score on a scale
Standard Deviation 9.30
|
SECONDARY outcome
Timeframe: Session 2 - Day 1Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \>34 - severe depression)
Outcome measures
| Measure |
Placebo
n=52 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=51 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=48 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
|
17.75 score on a scale
Standard Deviation 11.16
|
17.02 score on a scale
Standard Deviation 13.02
|
12.94 score on a scale
Standard Deviation 9.50
|
SECONDARY outcome
Timeframe: Session 3 - Day 3Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \>34 - severe depression)
Outcome measures
| Measure |
Placebo
n=51 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=50 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=44 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
|
19.98 score on a scale
Standard Deviation 11.22
|
19.34 score on a scale
Standard Deviation 12.77
|
17.86 score on a scale
Standard Deviation 11.55
|
SECONDARY outcome
Timeframe: Session 4 - Day 7Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \>34 - severe depression)
Outcome measures
| Measure |
Placebo
n=47 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=46 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=43 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
|
19.94 score on a scale
Standard Deviation 11.64
|
17.83 score on a scale
Standard Deviation 13.11
|
18.54 score on a scale
Standard Deviation 10.62
|
SECONDARY outcome
Timeframe: Session 5 - Day 10Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \>34 - severe depression)
Outcome measures
| Measure |
Placebo
n=47 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=45 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=46 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
|
20.70 score on a scale
Standard Deviation 11.79
|
16.64 score on a scale
Standard Deviation 12.90
|
18.07 score on a scale
Standard Deviation 9.98
|
SECONDARY outcome
Timeframe: Session 6 - Day 14Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \>34 - severe depression)
Outcome measures
| Measure |
Placebo
n=44 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=48 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=42 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
|
18.36 score on a scale
Standard Deviation 11.90
|
16.71 score on a scale
Standard Deviation 13.47
|
16.83 score on a scale
Standard Deviation 9.91
|
SECONDARY outcome
Timeframe: Session 7 - Day 17Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \>34 - severe depression)
Outcome measures
| Measure |
Placebo
n=44 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=47 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=41 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
|
17.02 score on a scale
Standard Deviation 12.52
|
14.75 score on a scale
Standard Deviation 12.98
|
15.15 score on a scale
Standard Deviation 10.35
|
SECONDARY outcome
Timeframe: Session 8 - Day 21Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \>34 - severe depression)
Outcome measures
| Measure |
Placebo
n=42 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=42 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=40 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
|
17.02 score on a scale
Standard Deviation 12.52
|
16.44 score on a scale
Standard Deviation 13.66
|
15.78 score on a scale
Standard Deviation 11.59
|
SECONDARY outcome
Timeframe: Session 9 - Day 24Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \>34 - severe depression)
Outcome measures
| Measure |
Placebo
n=45 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=45 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=42 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
|
17.11 score on a scale
Standard Deviation 11.75
|
14.43 score on a scale
Standard Deviation 12.29
|
14.24 score on a scale
Standard Deviation 10.59
|
SECONDARY outcome
Timeframe: Follow-up 1 - Day 25Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \>34 - severe depression)
Outcome measures
| Measure |
Placebo
n=44 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=42 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=41 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
|
15.98 score on a scale
Standard Deviation 12.32
|
12.91 score on a scale
Standard Deviation 12.60
|
10.78 score on a scale
Standard Deviation 9.85
|
SECONDARY outcome
Timeframe: Follow-up 2 - Day 28Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \>34 - severe depression)
Outcome measures
| Measure |
Placebo
n=25 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=18 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=12 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
|
24.00 score on a scale
Standard Deviation 10.30
|
25.11 score on a scale
Standard Deviation 12.20
|
25.08 score on a scale
Standard Deviation 7.34
|
SECONDARY outcome
Timeframe: Follow-up 3 - Day 29Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \>34 - severe depression)
Outcome measures
| Measure |
Placebo
n=24 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=17 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=11 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
|
15.00 score on a scale
Standard Deviation 11.55
|
19.18 score on a scale
Standard Deviation 13.99
|
20.27 score on a scale
Standard Deviation 8.32
|
SECONDARY outcome
Timeframe: Follow-up 4 - Day 35Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \>34 - severe depression)
Outcome measures
| Measure |
Placebo
n=37 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=37 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=33 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
|
16.08 score on a scale
Standard Deviation 11.15
|
14.43 score on a scale
Standard Deviation 12.71
|
12.72 score on a scale
Standard Deviation 9.24
|
SECONDARY outcome
Timeframe: Follow-up 5 - Day 42Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \>34 - severe depression)
Outcome measures
| Measure |
Placebo
n=35 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=39 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=36 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
|
16.89 score on a scale
Standard Deviation 12.51
|
15.74 score on a scale
Standard Deviation 13.03
|
16.42 score on a scale
Standard Deviation 9.39
|
SECONDARY outcome
Timeframe: Follow-up 6 - Day 49Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \>34 - severe depression)
Outcome measures
| Measure |
Placebo
n=35 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=38 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=37 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
|
19.60 score on a scale
Standard Deviation 11.52
|
15.87 score on a scale
Standard Deviation 11.79
|
17.68 score on a scale
Standard Deviation 8.86
|
SECONDARY outcome
Timeframe: Follow-up 7 - Day 56Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \>34 - severe depression)
Outcome measures
| Measure |
Placebo
n=40 Participants
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=41 Participants
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=33 Participants
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
|
19.45 score on a scale
Standard Deviation 11.19
|
15.44 score on a scale
Standard Deviation 12.98
|
19.58 score on a scale
Standard Deviation 10.94
|
Adverse Events
Placebo
Low Dose Ketamine
High Dose Ketamine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=55 participants at risk
Saline dose
Placebo: This is a saline placebo/non-active solution.
|
Low Dose Ketamine
n=55 participants at risk
Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
High Dose Ketamine
n=53 participants at risk
High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
|
|---|---|---|---|
|
Social circumstances
agitation
|
0.00%
0/55 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
5.5%
3/55 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
5.7%
3/53 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
|
Psychiatric disorders
anxiety
|
0.00%
0/55 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
3.6%
2/55 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
3.8%
2/53 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
|
Gastrointestinal disorders
diarrhea
|
3.6%
2/55 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
5.5%
3/55 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
3.8%
2/53 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
|
General disorders
fatigue
|
3.6%
2/55 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
5.5%
3/55 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
7.5%
4/53 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
|
General disorders
headache
|
12.7%
7/55 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
25.5%
14/55 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
11.3%
6/53 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
|
Social circumstances
irritability
|
0.00%
0/55 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
9.1%
5/55 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
5.7%
3/53 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
|
Gastrointestinal disorders
nausea/GI disturb
|
14.5%
8/55 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
14.5%
8/55 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
15.1%
8/53 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
|
General disorders
nightmares
|
3.6%
2/55 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
1.8%
1/55 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
3.8%
2/53 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
|
General disorders
soreness/bruising at INJ site
|
3.6%
2/55 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
0.00%
0/55 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
1.9%
1/53 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
|
Psychiatric disorders
depression
|
1.8%
1/55 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
1.8%
1/55 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
1.9%
1/53 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
|
Psychiatric disorders
suicidality
|
1.8%
1/55 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
1.8%
1/55 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
1.9%
1/53 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/55 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
0.00%
0/55 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
5.7%
3/53 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
|
General disorders
sweating
|
0.00%
0/55 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
1.8%
1/55 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
3.8%
2/53 • The study duration was 5 years; time Veterans participated was ~2 months total.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place