CAP-Ketamine for Antidepressant Resistant PTSD

• ClinicalTrials.gov Identifier: NCT02655692
• Recruitment Status: Completed
• First Posted: January 14, 2016
• Results First Posted: June 2, 2022
• Last Update Posted: June 2, 2022
• Sponsor: VA Office of Research and Development
• Collaborators: The University of Texas Health Science Center at San Antonio; Brooke Army Medical Center; Minneapolis Veterans Affairs Medical Center
• Information provided by (Responsible Party): VA Office of Research and Development

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Conditions: PTSD; Posttraumatic Stress Disorder
• Interventions: Drug: Ketamine; Drug: Placebo/Saline
• Enrollment: 163

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Period Title: Overall Study
Started	55	55	53
Completed	36	41	40
Not Completed	19	14	13

Baseline Characteristics

Arm/Group Title		Placebo	Low Dose Ketamine	High Dose Ketamine	Total
Arm/Group Description		Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	Total of all reporting groups
Overall Number of Baseline Participants		54	53	51	158
Baseline Analysis Population Description		All available data was utilized in the analysis using raw means and SDs
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	54 participants	53 participants	51 participants	158 participants
		42 (1.5)	45 (1.5)	43 (1.8)	43.3 (11.5)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	54 participants	53 participants	51 participants	158 participants
	Female	14 25.9%	10 18.9%	13 25.5%	37 23.4%
	Male	40 74.1%	43 81.1%	38 74.5%	121 76.6%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	54 participants	53 participants	51 participants	158 participants
White - non Hispanic		37 68.5%	28 52.8%	29 56.9%	94 59.5%
Black		6 11.1%	7 13.2%	7 13.7%	20 12.7%
Hispanic		8 14.8%	11 20.8%	12 23.5%	31 19.6%
Other		3 5.6%	7 13.2%	3 5.9%	13 8.2%
PCL [1]; Mean (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	54 participants	53 participants	51 participants	158 participants
		51.95 (10.82)	51.75 (12.38)	50.23 (14.69)	51.33 (12.62)
		[1] Measure Description: The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure. A total symptom severity score (range - 0-80) with higher scores indicating greater severity.

Outcome Measures

1. Primary Outcome

Title	PTSD Checklist (PCL)
Description	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
Time Frame	Session 1 -Day 0

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description:	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Overall Number of Participants Analyzed	54	53	51
Mean (Standard Deviation); Unit of Measure: units on a scale
	48.56 (12.76)	46.62 (17.71)	47.88 (14.46)

2. Primary Outcome

Title	The PTSD Checklist (PCL)
Description	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
Time Frame	Session 2 - Day 1

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description:	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Overall Number of Participants Analyzed	52	51	49
Mean (Standard Deviation); Unit of Measure: units on a scale
	37.65 (18.40)	32.75 (19.39)	30.10 (20.25)

3. Primary Outcome

Title	The PTSD Checklist (PCL)
Description	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
Time Frame	Session 3 - Day 3

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description:	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Overall Number of Participants Analyzed	51	50	44
Mean (Standard Deviation); Unit of Measure: units on a scale
	36.90 (18.11)	33.66 (18.67)	34.20 (18.37)

4. Primary Outcome

Title	The PTSD Checklist (PCL)
Description	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
Time Frame	Session 4 - Day 7

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description:	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Overall Number of Participants Analyzed	48	47	43
Mean (Standard Deviation); Unit of Measure: units on a scale
	34.75 (18.96)	29.09 (20.61)	32.58 (19.12)

5. Primary Outcome

Title	The PTSD Checklist (PCL)
Description	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
Time Frame	Session 5 - Day 10

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description:	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Overall Number of Participants Analyzed	47	45	46
Mean (Standard Deviation); Unit of Measure: units on a scale
	35.11 (18.84)	28.51 (21.12)	31.46 (18.60)

6. Primary Outcome

Title	The PTSD Checklist (PCL)
Description	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
Time Frame	Session 6 - Day 14

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description:	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Overall Number of Participants Analyzed	44	48	43
Mean (Standard Deviation); Unit of Measure: units on a scale
	30.80 (19.85)	26.40 (21.12)	27.91 (17.04)

7. Primary Outcome

Title	The PTSD Checklist (PCL)
Description	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
Time Frame	Session 7 - Day 17

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description:	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Overall Number of Participants Analyzed	44	47	41
Mean (Standard Deviation); Unit of Measure: units on a scale
	28.48 (19.47)	24.13 (20.15)	26.54 (17.58)

8. Primary Outcome

Title	The PTSD Checklist (PCL)
Description	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
Time Frame	Session 8 - Day 21

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description:	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Overall Number of Participants Analyzed	42	42	40
Mean (Standard Deviation); Unit of Measure: units on a scale
	29.31 (20.39)	24.52 (20.45)	26.73 (17.20)

9. Primary Outcome

Title	The PTSD Checklist (PCL)
Description	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
Time Frame	Session 9 - Day 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description:	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Overall Number of Participants Analyzed	45	46	42
Mean (Standard Deviation); Unit of Measure: units on a scale
	28.31 (19.89)	21.94 (20.35)	25.62 (19.86)

10. Primary Outcome

Title	The PTSD Checklist (PCL)
Description	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
Time Frame	Follow-up 1 - Day 25

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description:	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Overall Number of Participants Analyzed	44	43	41
Mean (Standard Deviation); Unit of Measure: units on a scale
	27.34 (20.25)	21.35 (20.70)	22.54 (17.98)

11. Primary Outcome

Title	The PTSD Checklist (PCL)
Description	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
Time Frame	Follow-up 2 - Day 28

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description:	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Overall Number of Participants Analyzed	25	17	12
Mean (Standard Deviation); Unit of Measure: units on a scale
	37.84 (18.37)	34.59 (18.45)	39.58 (15.55)

12. Primary Outcome

Title	The PTSD Checklist (PCL)
Description	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
Time Frame	Follow-up 3 - Day 29

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description:	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Overall Number of Participants Analyzed	24	18	11
Mean (Standard Deviation); Unit of Measure: units on a scale
	33.79 (19.80)	33.72 (20.17)	40.27 (16.29)

13. Primary Outcome

Title	The PTSD Checklist (PCL)
Description	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
Time Frame	Follow-up 4 - Day 35

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description:	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Overall Number of Participants Analyzed	38	38	33
Mean (Standard Deviation); Unit of Measure: units on a scale
	26.92 (19.17)	22.84 (21.46)	24.09 (17.05)

14. Primary Outcome

Title	The PTSD Checklist (PCL)
Description	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
Time Frame	Follow-up 5 - Day 42

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description:	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Overall Number of Participants Analyzed	35	39	37
Mean (Standard Deviation); Unit of Measure: units on a scale
	28.14 (20.92)	25.62 (21.81)	29.16 (19.85)

15. Primary Outcome

Title	The PTSD Checklist (PCL)
Description	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
Time Frame	Follow-up 6 - Day 49

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description:	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Overall Number of Participants Analyzed	35	39	38
Mean (Standard Deviation); Unit of Measure: units on a scale
	30.71 (21.33)	24.90 (20.66)	30.21 (18.82)

16. Primary Outcome

Title	The PTSD Checklist (PCL)
Description	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
Time Frame	Follow-up 7 - Day 56

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description:	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Overall Number of Participants Analyzed	39	41	35
Mean (Standard Deviation); Unit of Measure: units on a scale
	31.90 (21.08)	24.32 (21.15)	31.23 (19.81)

17. Secondary Outcome

Title	Montgomery-Asberg Depression Rating Scale (MADRS)
Description	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)
Time Frame	Session 1 - Day 0

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description:	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Overall Number of Participants Analyzed	54	52	51
Mean (Standard Deviation); Unit of Measure: score on a scale
	28.24 (8.43)	27.81 (10.30)	27.84 (9.30)

18. Secondary Outcome

Title	Montgomery-Asberg Depression Rating Scale (MADRS)
Description	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)
Time Frame	Session 2 - Day 1

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description:	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Overall Number of Participants Analyzed	52	51	48
Mean (Standard Deviation); Unit of Measure: score on a scale
	17.75 (11.16)	17.02 (13.02)	12.94 (9.50)

19. Secondary Outcome

Title	Montgomery-Asberg Depression Rating Scale (MADRS)
Description	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)
Time Frame	Session 3 - Day 3

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description:	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Overall Number of Participants Analyzed	51	50	44
Mean (Standard Deviation); Unit of Measure: score on a scale
	19.98 (11.22)	19.34 (12.77)	17.86 (11.55)

20. Secondary Outcome

Title	Montgomery-Asberg Depression Rating Scale (MADRS)
Description	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)
Time Frame	Session 4 - Day 7

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description:	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Overall Number of Participants Analyzed	47	46	43
Mean (Standard Deviation); Unit of Measure: score on a scale
	19.94 (11.64)	17.83 (13.11)	18.54 (10.62)

21. Secondary Outcome

Title	Montgomery-Asberg Depression Rating Scale (MADRS)
Description	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)
Time Frame	Session 5 - Day 10

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description:	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Overall Number of Participants Analyzed	47	45	46
Mean (Standard Deviation); Unit of Measure: score on a scale
	20.70 (11.79)	16.64 (12.90)	18.07 (9.98)

22. Secondary Outcome

Title	Montgomery-Asberg Depression Rating Scale (MADRS)
Description	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)
Time Frame	Session 6 - Day 14

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description:	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Overall Number of Participants Analyzed	44	48	42
Mean (Standard Deviation); Unit of Measure: score on a scale
	18.36 (11.90)	16.71 (13.47)	16.83 (9.91)

23. Secondary Outcome

Title	Montgomery-Asberg Depression Rating Scale (MADRS)
Description	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)
Time Frame	Session 7 - Day 17

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description:	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Overall Number of Participants Analyzed	44	47	41
Mean (Standard Deviation); Unit of Measure: score on a scale
	17.02 (12.52)	14.75 (12.98)	15.15 (10.35)

24. Secondary Outcome

Title	Montgomery-Asberg Depression Rating Scale (MADRS)
Description	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)
Time Frame	Session 8 - Day 21

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description:	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Overall Number of Participants Analyzed	42	42	40
Mean (Standard Deviation); Unit of Measure: score on a scale
	17.02 (12.52)	16.44 (13.66)	15.78 (11.59)

25. Secondary Outcome

Title	Montgomery-Asberg Depression Rating Scale (MADRS)
Description	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)
Time Frame	Session 9 - Day 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description:	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Overall Number of Participants Analyzed	45	45	42
Mean (Standard Deviation); Unit of Measure: score on a scale
	17.11 (11.75)	14.43 (12.29)	14.24 (10.59)

26. Secondary Outcome

Title	Montgomery-Asberg Depression Rating Scale (MADRS)
Description	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)
Time Frame	Follow-up 1 - Day 25

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description:	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Overall Number of Participants Analyzed	44	42	41
Mean (Standard Deviation); Unit of Measure: score on a scale
	15.98 (12.32)	12.91 (12.60)	10.78 (9.85)

27. Secondary Outcome

Title	Montgomery-Asberg Depression Rating Scale (MADRS)
Description	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)
Time Frame	Follow-up 2 - Day 28

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description:	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Overall Number of Participants Analyzed	25	18	12
Mean (Standard Deviation); Unit of Measure: score on a scale
	24.00 (10.30)	25.11 (12.20)	25.08 (7.34)

28. Secondary Outcome

Title	Montgomery-Asberg Depression Rating Scale (MADRS)
Description	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)
Time Frame	Follow-up 3 - Day 29

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description:	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Overall Number of Participants Analyzed	24	17	11
Mean (Standard Deviation); Unit of Measure: score on a scale
	15.00 (11.55)	19.18 (13.99)	20.27 (8.32)

29. Secondary Outcome

Title	Montgomery-Asberg Depression Rating Scale (MADRS)
Description	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)
Time Frame	Follow-up 4 - Day 35

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description:	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Overall Number of Participants Analyzed	37	37	33
Mean (Standard Deviation); Unit of Measure: score on a scale
	16.08 (11.15)	14.43 (12.71)	12.72 (9.24)

30. Secondary Outcome

Title	Montgomery-Asberg Depression Rating Scale (MADRS)
Description	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)
Time Frame	Follow-up 5 - Day 42

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description:	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Overall Number of Participants Analyzed	35	39	36
Mean (Standard Deviation); Unit of Measure: score on a scale
	16.89 (12.51)	15.74 (13.03)	16.42 (9.39)

31. Secondary Outcome

Title	Montgomery-Asberg Depression Rating Scale (MADRS)
Description	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)
Time Frame	Follow-up 6 - Day 49

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description:	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Overall Number of Participants Analyzed	35	38	37
Mean (Standard Deviation); Unit of Measure: score on a scale
	19.60 (11.52)	15.87 (11.79)	17.68 (8.86)

32. Secondary Outcome

Title	Montgomery-Asberg Depression Rating Scale (MADRS)
Description	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)
Time Frame	Follow-up 7 - Day 56

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description:	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
Overall Number of Participants Analyzed	40	41	33
Mean (Standard Deviation); Unit of Measure: score on a scale
	19.45 (11.19)	15.44 (12.98)	19.58 (10.94)

Adverse Events

Time Frame	The study duration was 5 years; time Veterans participated was ~2 months total.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Placebo	Low Dose Ketamine	High Dose Ketamine
Arm/Group Description	Saline dose Placebo: This is a saline placebo/non-active solution.	Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.	High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects.
All-Cause Mortality
	Placebo	Low Dose Ketamine	High Dose Ketamine
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/55 (0.00%)	0/55 (0.00%)	0/53 (0.00%)
Serious Adverse Events
	Placebo	Low Dose Ketamine	High Dose Ketamine
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/55 (0.00%)	0/55 (0.00%)	0/53 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Placebo	Low Dose Ketamine	High Dose Ketamine
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	25/55 (45.45%)	42/55 (76.36%)	38/53 (71.70%)
Gastrointestinal disorders
diarrhea †	2/55 (3.64%)	3/55 (5.45%)	2/53 (3.77%)
nausea/GI disturb †	8/55 (14.55%)	8/55 (14.55%)	8/53 (15.09%)
constipation †	0/55 (0.00%)	0/55 (0.00%)	3/53 (5.66%)
General disorders
fatigue †	2/55 (3.64%)	3/55 (5.45%)	4/53 (7.55%)
headache †	7/55 (12.73%)	14/55 (25.45%)	6/53 (11.32%)
nightmares †	2/55 (3.64%)	1/55 (1.82%)	2/53 (3.77%)
soreness/bruising at INJ site †	2/55 (3.64%)	0/55 (0.00%)	1/53 (1.89%)
sweating †	0/55 (0.00%)	1/55 (1.82%)	2/53 (3.77%)
Psychiatric disorders
anxiety †	0/55 (0.00%)	2/55 (3.64%)	2/53 (3.77%)
depression †	1/55 (1.82%)	1/55 (1.82%)	1/53 (1.89%)
suicidality †	1/55 (1.82%)	1/55 (1.82%)	1/53 (1.89%)
Social circumstances
agitation †	0/55 (0.00%)	3/55 (5.45%)	3/53 (5.66%)
irritability †	0/55 (0.00%)	5/55 (9.09%)	3/53 (5.66%)
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: John Krystal
• Organization: Yale University
• Phone: 203.785.6396
• EMail: john.krystal@yale.edu

Publications:

Abdallah CG, Roache JD, Averill LA, Young-McCaughan S, Martini B, Gueorguieva R, Amoroso T, Southwick SM, Guthmiller K, Lopez-Roca AL, Lautenschlager K, Mintz J, Litz BT, Williamson DE, Keane TM, Peterson AL, Krystal JH; Consortium to Alleviate PTSD. Repeated ketamine infusions for antidepressant-resistant PTSD: Methods of a multicenter, randomized, placebo-controlled clinical trial. Contemp Clin Trials. 2019 Jun;81:11-18. doi: 10.1016/j.cct.2019.04.009. Epub 2019 Apr 15.

Abdallah CG, Roache JD, Gueorguieva R, Averill LA, Young-McCaughan S, Shiroma PR, Purohit P, Brundige A, Murff W, Ahn KH, Sherif MA, Baltutis EJ, Ranganathan M, D'Souza D, Martini B, Southwick SM, Petrakis IL, Burson RR, Guthmiller KB, Lopez-Roca AL, Lautenschlager KA, McCallin JP 3rd, Hoch MB, Timchenko A, Souza SE, Bryant CE, Mintz J, Litz BT, Williamson DE, Keane TM, Peterson AL, Krystal JH. Dose-related effects of ketamine for antidepressant-resistant symptoms of posttraumatic stress disorder in veterans and active duty military: a double-blind, randomized, placebo-controlled multi-center clinical trial. Neuropsychopharmacology. 2022 Jul;47(8):1574-1581. doi: 10.1038/s41386-022-01266-9. Epub 2022 Jan 19. Erratum In: Neuropsychopharmacology. 2022 May 11;:

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02655692
• Other Study ID Numbers: SPLE-003-14W
• First Submitted: January 7, 2016
• First Posted: January 14, 2016
• Results First Submitted: October 25, 2021
• Results First Posted: June 2, 2022
• Last Update Posted: June 2, 2022