Trial Outcomes & Findings for Intensive 7-day Treatment for PTSD Combining Ketamine With Exposure Therapy (NCT NCT02727998)
NCT ID: NCT02727998
Last Updated: 2022-10-17
Results Overview
PTSD symptoms severity will be evaluated overtime using the PTSD Checklist for DSM-5 (PCL-5), a 20 items self-report measure. Items are scored 0-4 (0=not at all to 4=Extremely), thus total PCL-5 score ranges from 0 to 80. Higher scores reflect greater severity of PTSD. Total PCL-5 scores are reported. PCL score\>33 indicates probable PTSD diagnosis. Evidence for the PCL suggested 5 points reduction as a minimum threshold for determining whether an individual has responded to treatment and 10 points reduction in the PCL-5 as a minimum threshold for determining whether the improvement is clinically meaningful.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
Baseline, 7 days, 30 days and 90 days
Results posted on
2022-10-17
Participant Flow
Participant milestones
| Measure |
Single Infusion of Ketamine With Prolonged Exposure
After the reactivation of the scripted memories during PE on day 2, the ketamine infusion procedure will begin inside the MRI. A physician will oversee and administer the ketamine infusions. A nurse will accompany the subject throughout the study sessions, from the insertion of bilateral cannula for drug infusion and blood sampling, to the recovery following ketamine infusion. Whilst subjects undergo the infusion, their heart rate and blood pressure will be constantly monitored. The participant will receive a steady state ketamine infusion of 0.50 mg/kg/hour. The infusion will continue for 40 minutes.
Ketamine: Prolonged exposure therapy combined with a single infusion of 0.50 mg/kg/hour for 40 min on day 2.
|
Midazolam With Prolonged Exposure
After the reactivation of the scripted memories during PE on day 2, the midazolam infusion procedure will begin inside the MRI. A physician will oversee and administer the Midazolam infusions. A nurse will accompany the subject throughout the study sessions, from the insertion of bilateral cannula for drug infusion and blood sampling, to the recovery following midazolam infusion. Whilst subjects undergo the infusion, their heart rate and blood pressure will be constantly monitored. The participant will receive a steady midazolam infusions at a rate 0.045 mg/kg for 40 minutes.
Midazolam: Prolonged exposure therapy combined with a single infusion of 0.045 mg/kg/hour for 40 min on day 2.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
End of Treatment (7 Days)
|
13
|
13
|
|
Overall Study
30 Days Follow Up
|
13
|
11
|
|
Overall Study
90 Days Follow Up
|
11
|
10
|
|
Overall Study
COMPLETED
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Single Infusion of Ketamine With Prolonged Exposure
After the reactivation of the scripted memories during PE on day 2, the ketamine infusion procedure will begin inside the MRI. A physician will oversee and administer the ketamine infusions. A nurse will accompany the subject throughout the study sessions, from the insertion of bilateral cannula for drug infusion and blood sampling, to the recovery following ketamine infusion. Whilst subjects undergo the infusion, their heart rate and blood pressure will be constantly monitored. The participant will receive a steady state ketamine infusion of 0.50 mg/kg/hour. The infusion will continue for 40 minutes.
Ketamine: Prolonged exposure therapy combined with a single infusion of 0.50 mg/kg/hour for 40 min on day 2.
|
Midazolam With Prolonged Exposure
After the reactivation of the scripted memories during PE on day 2, the midazolam infusion procedure will begin inside the MRI. A physician will oversee and administer the Midazolam infusions. A nurse will accompany the subject throughout the study sessions, from the insertion of bilateral cannula for drug infusion and blood sampling, to the recovery following midazolam infusion. Whilst subjects undergo the infusion, their heart rate and blood pressure will be constantly monitored. The participant will receive a steady midazolam infusions at a rate 0.045 mg/kg for 40 minutes.
Midazolam: Prolonged exposure therapy combined with a single infusion of 0.045 mg/kg/hour for 40 min on day 2.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Intensive 7-day Treatment for PTSD Combining Ketamine With Exposure Therapy
Baseline characteristics by cohort
| Measure |
Single Infusion of Ketamine With Prolonged Exposure
n=14 Participants
After the reactivation of the scripted memories during PE on day 2, the ketamine infusion procedure will begin inside the MRI. A physician will oversee and administer the ketamine infusions. A nurse will accompany the subject throughout the study sessions, from the insertion of bilateral cannula for drug infusion and blood sampling, to the recovery following ketamine infusion. Whilst subjects undergo the infusion, their heart rate and blood pressure will be constantly monitored. The participant will receive a steady state ketamine infusion of 0.50 mg/kg/hour. The infusion will continue for 40 minutes.
Ketamine: Prolonged exposure therapy combined with a single infusion of 0.50 mg/kg/hour for 40 min on day 2.
|
Midazolam With Prolonged Exposure
n=14 Participants
After the reactivation of the scripted memories during PE on day 2, the midazolam infusion procedure will begin inside the MRI. A physician will oversee and administer the Midazolam infusions. A nurse will accompany the subject throughout the study sessions, from the insertion of bilateral cannula for drug infusion and blood sampling, to the recovery following midazolam infusion. Whilst subjects undergo the infusion, their heart rate and blood pressure will be constantly monitored. The participant will receive a steady midazolam infusions at a rate 0.045 mg/kg for 40 minutes.
Midazolam: Prolonged exposure therapy combined with a single infusion of 0.045 mg/kg/hour for 40 min on day 2.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.7 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
35.1 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
38.1 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 7 days, 30 days and 90 daysPopulation: The number that completed each assessment are presented and summarized- one participant in Midazolam arm was not included due to drop out prior to first assessment.
PTSD symptoms severity will be evaluated overtime using the PTSD Checklist for DSM-5 (PCL-5), a 20 items self-report measure. Items are scored 0-4 (0=not at all to 4=Extremely), thus total PCL-5 score ranges from 0 to 80. Higher scores reflect greater severity of PTSD. Total PCL-5 scores are reported. PCL score\>33 indicates probable PTSD diagnosis. Evidence for the PCL suggested 5 points reduction as a minimum threshold for determining whether an individual has responded to treatment and 10 points reduction in the PCL-5 as a minimum threshold for determining whether the improvement is clinically meaningful.
Outcome measures
| Measure |
Single Infusion of Ketamine With Prolonged Exposure
n=14 Participants
After the reactivation of the scripted memories during PE on day 2, the ketamine infusion procedure will begin inside the MRI. A physician will oversee and administer the ketamine infusions. A nurse will accompany the subject throughout the study sessions, from the insertion of bilateral cannula for drug infusion and blood sampling, to the recovery following ketamine infusion. Whilst subjects undergo the infusion, their heart rate and blood pressure will be constantly monitored. The participant will receive a steady state ketamine infusion of 0.50 mg/kg/hour. The infusion will continue for 40 minutes.
Ketamine: Prolonged exposure therapy combined with a single infusion of 0.50 mg/kg/hour for 40 min on day 2.
|
Midazolam With Prolonged Exposure
n=13 Participants
After the reactivation of the scripted memories during PE on day 2, the midazolam infusion procedure will begin inside the MRI. A physician will oversee and administer the Midazolam infusions. A nurse will accompany the subject throughout the study sessions, from the insertion of bilateral cannula for drug infusion and blood sampling, to the recovery following midazolam infusion. Whilst subjects undergo the infusion, their heart rate and blood pressure will be constantly monitored. The participant will receive a steady midazolam infusions at a rate 0.045 mg/kg for 40 minutes.
Midazolam: Prolonged exposure therapy combined with a single infusion of 0.045 mg/kg/hour for 40 min on day 2.
|
|---|---|---|
|
Change in PTSD Symptoms
Baseline
|
48.8 score on a scale
Standard Deviation 12.3
|
44.4 score on a scale
Standard Deviation 14.4
|
|
Change in PTSD Symptoms
End of Treatment (7 days)
|
29.5 score on a scale
Standard Deviation 20.7
|
35.1 score on a scale
Standard Deviation 16.8
|
|
Change in PTSD Symptoms
30 Days Follow Up
|
32.7 score on a scale
Standard Deviation 14.9
|
28.5 score on a scale
Standard Deviation 17.2
|
|
Change in PTSD Symptoms
90 Days Follow Up
|
34.2 score on a scale
Standard Deviation 18.6
|
28.7 score on a scale
Standard Deviation 18.3
|
SECONDARY outcome
Timeframe: Baseline, 7 days, 30 days and 90 daysPopulation: The number that completed each assessment are presented and summarized- one participant in Midazolam arm was not included due to drop out prior to first assessment.
The self-report BDI-II will be used to assess severity of depressive symptoms. A higher score is associated with higher severity of depression. The score is interpreted as follows: 0-13 indicates minimal depression, 14-19 indicates mild depression, 20-28 indicates moderate depression and 29-63 indicates severe depression
Outcome measures
| Measure |
Single Infusion of Ketamine With Prolonged Exposure
n=14 Participants
After the reactivation of the scripted memories during PE on day 2, the ketamine infusion procedure will begin inside the MRI. A physician will oversee and administer the ketamine infusions. A nurse will accompany the subject throughout the study sessions, from the insertion of bilateral cannula for drug infusion and blood sampling, to the recovery following ketamine infusion. Whilst subjects undergo the infusion, their heart rate and blood pressure will be constantly monitored. The participant will receive a steady state ketamine infusion of 0.50 mg/kg/hour. The infusion will continue for 40 minutes.
Ketamine: Prolonged exposure therapy combined with a single infusion of 0.50 mg/kg/hour for 40 min on day 2.
|
Midazolam With Prolonged Exposure
n=13 Participants
After the reactivation of the scripted memories during PE on day 2, the midazolam infusion procedure will begin inside the MRI. A physician will oversee and administer the Midazolam infusions. A nurse will accompany the subject throughout the study sessions, from the insertion of bilateral cannula for drug infusion and blood sampling, to the recovery following midazolam infusion. Whilst subjects undergo the infusion, their heart rate and blood pressure will be constantly monitored. The participant will receive a steady midazolam infusions at a rate 0.045 mg/kg for 40 minutes.
Midazolam: Prolonged exposure therapy combined with a single infusion of 0.045 mg/kg/hour for 40 min on day 2.
|
|---|---|---|
|
Change in Beck Depression Inventory (BDI-II)
Baseline
|
48.5 score on a scale
Standard Deviation 5.7
|
47.6 score on a scale
Standard Deviation 13.3
|
|
Change in Beck Depression Inventory (BDI-II)
End of Treatment (7 Days)
|
38.9 score on a scale
Standard Deviation 13.7
|
39.9 score on a scale
Standard Deviation 11.8
|
|
Change in Beck Depression Inventory (BDI-II)
30 Days Follow Up
|
43.0 score on a scale
Standard Deviation 12.0
|
36.5 score on a scale
Standard Deviation 12.0
|
|
Change in Beck Depression Inventory (BDI-II)
90 Days Follow Up
|
42.8 score on a scale
Standard Deviation 11.4
|
36.8 score on a scale
Standard Deviation 15.8
|
Adverse Events
Single Infusion of Ketamine With Prolonged Exposure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Midazolam With Prolonged Exposure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place