Trial Outcomes & Findings for Ketamine and Prolonged Exposure in PTSD (NCT NCT03960658)
NCT ID: NCT03960658
Last Updated: 2021-03-22
Results Overview
The overall severity of PTSD symptoms would be measured by the mean change in the Past Month (current) total scores on the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (CAPS-5) from baseline to post-treatment (10 weeks). The CAPS-5 is a structured interview with higher values representing worse outcomes. The CAPS-5 total symptom severity score ranges from 0 to 80 and it is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms.
COMPLETED
PHASE1/PHASE2
12 participants
10 weeks
2021-03-22
Participant Flow
Participant milestones
| Measure |
Ketamine and Prolonged Exposure
Open-label intravenous ketamine 0.5 mg/kg 24 hours prior to prolonged exposure (PE) session 1,2 and 3 followed by up to 7 additional PE sessions.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ketamine and Prolonged Exposure in PTSD
Baseline characteristics by cohort
| Measure |
Ketamine and Prolonged Exposure
n=10 Participants
Open-label intravenous ketamine 0.5 mg/kg 24 hours prior to prolonged exposure (PE) session 1,2 and 3 followed by up to 7 additional PE sessions.
|
|---|---|
|
Age, Continuous
|
45.1 years
STANDARD_DEVIATION 14.9 • n=39 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=39 Participants
|
|
Post-traumatic Stress Disorder Check List DSM-5
|
56.3 units on a scale
STANDARD_DEVIATION 9.8 • n=39 Participants
|
|
Montgomery-Åsberg Depression rating Scale
|
25.0 units on a scale
STANDARD_DEVIATION 6.0 • n=39 Participants
|
PRIMARY outcome
Timeframe: 10 weeksPopulation: mean CAPS-5 score at 10 weeks minus mean CAPS-5 score at baseline
The overall severity of PTSD symptoms would be measured by the mean change in the Past Month (current) total scores on the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (CAPS-5) from baseline to post-treatment (10 weeks). The CAPS-5 is a structured interview with higher values representing worse outcomes. The CAPS-5 total symptom severity score ranges from 0 to 80 and it is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms.
Outcome measures
| Measure |
Ketamine and Prolonged Exposure
n=10 Participants
Open-label intravenous ketamine 0.5 mg/kg 24 hours prior to prolonged exposure (PE) session 1,2 and 3 followed by up to 7 additional PE sessions.
|
|---|---|
|
Change in Severity of Post-traumatic Stress Disorder (PTSD) Symptoms
|
15.3 units on a scale
Interval 7.3 to 23.2
|
SECONDARY outcome
Timeframe: 10 weeksPopulation: mean MADRS score at 10 weeks minus mean MADRS score at baseline
Total score on the Montgomery- Åsberg Depression Rating Scale , a semi- structured 10-item scale. Range 0-60. Higher values represent worse outcomes. The total score is obtained by summing the severity score of each item.
Outcome measures
| Measure |
Ketamine and Prolonged Exposure
n=10 Participants
Open-label intravenous ketamine 0.5 mg/kg 24 hours prior to prolonged exposure (PE) session 1,2 and 3 followed by up to 7 additional PE sessions.
|
|---|---|
|
Change in Severity of Depressive Symptoms
|
11.5 units on a scale
Interval 6.1 to 16.9
|
SECONDARY outcome
Timeframe: 10 weeksPopulation: mean PCL-5 score at 10 weeks minus mean PCL-5 score at baseline
The PTSD Checklist for DSM-5 (PCL5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Range from 0-80. Higher values represent worse outcomes.
Outcome measures
| Measure |
Ketamine and Prolonged Exposure
n=10 Participants
Open-label intravenous ketamine 0.5 mg/kg 24 hours prior to prolonged exposure (PE) session 1,2 and 3 followed by up to 7 additional PE sessions.
|
|---|---|
|
Change in PTSD Symptoms for DSM-5
|
30.8 score on a scale
Interval 20.1 to 41.4
|
Adverse Events
Ketamine and Prolonged Exposure
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ketamine and Prolonged Exposure
n=10 participants at risk
Open-label intravenous ketamine 0.5 mg/kg 24 hours prior to prolonged exposure (PE) session 1,2 and 3 followed by up to 7 additional PE sessions.
|
|---|---|
|
Gastrointestinal disorders
nausea
|
10.0%
1/10 • Number of events 2 • 6 months
|
|
Cardiac disorders
high blood pressure
|
30.0%
3/10 • Number of events 3 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place