Trial Outcomes & Findings for Adding Trauma-focused Psychotherapy to Ketamine Treatment for Chronic PTSD (NCT NCT04889664)
NCT ID: NCT04889664
Last Updated: 2024-10-08
Results Overview
Clinician Administered PTSD Scale for DSM-5 (CAPS-5), assessed at baseline (before the first infusion) and 12 weeks following the start of WET. The Clinician-Administered PTSD Scale (CAPS) is a 30-item structured diagnostic interview designed to measure frequency and intensity of PTSD symptoms. The symptoms are scored in a 0-4 Likert-type scale, total score ranging from 0 to 80, higher score indicates more symptoms
COMPLETED
PHASE2
16 participants
Baseline and Week 12
2024-10-08
Participant Flow
16 participants signed consent and considered enrolled
Participant milestones
| Measure |
Ketamine and Written Exposure Therapy
Intravenous Ketamine 0.5 mg/kg and Written Exposure Therapy
Ketamine: Repeated intravenous Ketamine infusions.
Written Exposure Therapy: WET is a brief, 5-session evidence-based written trauma-focused therapy
|
|---|---|
|
Screen
STARTED
|
16
|
|
Screen
COMPLETED
|
14
|
|
Screen
NOT COMPLETED
|
2
|
|
Study Treatment
STARTED
|
14
|
|
Study Treatment
COMPLETED
|
13
|
|
Study Treatment
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Ketamine and Written Exposure Therapy
Intravenous Ketamine 0.5 mg/kg and Written Exposure Therapy
Ketamine: Repeated intravenous Ketamine infusions.
Written Exposure Therapy: WET is a brief, 5-session evidence-based written trauma-focused therapy
|
|---|---|
|
Screen
Lost to Follow-up
|
1
|
|
Screen
Failed to meet screening criteria
|
1
|
|
Study Treatment
Exited by study team due to inappropriate behavior
|
1
|
Baseline Characteristics
Adding Trauma-focused Psychotherapy to Ketamine Treatment for Chronic PTSD
Baseline characteristics by cohort
| Measure |
Ketamine and Written Exposure Therapy
n=13 Participants
Intravenous Ketamine 0.5 mg/kg and Written Exposure Therapy
Ketamine: Repeated intravenous Ketamine infusions.
Written Exposure Therapy: WET is a brief, 5-session evidence-based written trauma-focused therapy
|
|---|---|
|
Age, Continuous
|
38.3 years
STANDARD_DEVIATION 7.5 • n=99 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Duration of PTSD
|
18.1 years
STANDARD_DEVIATION 14 • n=99 Participants
|
|
Number of Participants taking Concomitant treatment with psychotropic medication
|
6 Participants
n=99 Participants
|
|
Clinician Administered PTSD Scale (CAPS-5) score
|
40.5 units on a scale
STANDARD_DEVIATION 3.9 • n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Clinician Administered PTSD Scale for DSM-5 (CAPS-5), assessed at baseline (before the first infusion) and 12 weeks following the start of WET. The Clinician-Administered PTSD Scale (CAPS) is a 30-item structured diagnostic interview designed to measure frequency and intensity of PTSD symptoms. The symptoms are scored in a 0-4 Likert-type scale, total score ranging from 0 to 80, higher score indicates more symptoms
Outcome measures
| Measure |
Ketamine and Written Exposure Therapy
n=13 Participants
Intravenous Ketamine 0.5 mg/kg and Written Exposure Therapy
Ketamine: Repeated intravenous Ketamine infusions.
Written Exposure Therapy: WET is a brief, 5-session evidence-based written trauma-focused therapy
|
|---|---|
|
CAPS-5
Baseline, the morning of first ketamine infusion
|
41.6 score on a scale
Standard Deviation 6.2
|
|
CAPS-5
Week 12
|
20.8 score on a scale
Standard Deviation 14.8
|
Adverse Events
Ketamine and Written Exposure Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ketamine and Written Exposure Therapy
n=13 participants at risk
Intravenous Ketamine 0.5 mg/kg and Written Exposure Therapy
Ketamine: Repeated intravenous Ketamine infusions.
Written Exposure Therapy: WET is a brief, 5-session evidence-based written trauma-focused therapy
|
|---|---|
|
Nervous system disorders
Dizziness
|
38.5%
5/13 • 12 weeks
|
|
Renal and urinary disorders
Frequent Urination
|
15.4%
2/13 • 12 weeks
|
|
General disorders
Difficulty Sleeping
|
15.4%
2/13 • 12 weeks
|
|
Reproductive system and breast disorders
Menstrual Irregularity
|
15.4%
2/13 • 12 weeks
|
|
General disorders
Fatigue
|
84.6%
11/13 • 12 weeks
|
|
General disorders
Decreased energy
|
7.7%
1/13 • 12 weeks
|
|
General disorders
Anxiety
|
7.7%
1/13 • 12 weeks
|
|
General disorders
Other
|
69.2%
9/13 • 12 weeks
|
|
Gastrointestinal disorders
Nausea/vomiting
|
15.4%
2/13 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Increased Perspiration
|
7.7%
1/13 • 12 weeks
|
|
Nervous system disorders
Headache
|
38.5%
5/13 • 12 weeks
|
|
Nervous system disorders
Blurred Vision
|
23.1%
3/13 • 12 weeks
|
Additional Information
Dr. Adriana Feder
Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place