Trial Outcomes & Findings for Prolonged Exposure for Post Traumatic Stress Disorder (PTSD) With/Without Yohimbine (NCT NCT01031979)
NCT ID: NCT01031979
Last Updated: 2018-02-07
Results Overview
The primary outcome was trauma-cued heart rate reactivity a week after the drug visit as measured by the PTSD Brief Reactivity (PBR) task. For each patient, a 3-minute trauma script was constructed containing vivid details of the target trauma and used in tandem with a standard neutral script for baseline measurement. Heart rate reactivity for each time point was the beats per minute (BPM) difference between the neutral and trauma scripts represented as a slope.
COMPLETED
PHASE2
26 participants
One week after drug visit
2018-02-07
Participant Flow
Participant milestones
| Measure |
Yohimbime Group
Patients will take one 21.6 mg. dose of yohimbine one hour before first imaginal exposure in PE.
Yohimbine: alpha-2 adrenergic receptor antagonist
|
Placebo Group
Patients will take a placebo one hour before first imaginal exposure in PE.
Placebo: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
12
|
|
Overall Study
Completed Primary Outcome Measure
|
12
|
12
|
|
Overall Study
COMPLETED
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Yohimbime Group
Patients will take one 21.6 mg. dose of yohimbine one hour before first imaginal exposure in PE.
Yohimbine: alpha-2 adrenergic receptor antagonist
|
Placebo Group
Patients will take a placebo one hour before first imaginal exposure in PE.
Placebo: Placebo
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
4
|
Baseline Characteristics
Prolonged Exposure for Post Traumatic Stress Disorder (PTSD) With/Without Yohimbine
Baseline characteristics by cohort
| Measure |
Yohimbine Group
n=12 Participants
Patients will take one 21.6 mg. dose of yohimbine one hour before first imaginal exposure in PE.
Yohimbine: alpha-2 adrenergic receptor antagonist
|
Placebo Group
n=12 Participants
Patients will take a placebo one hour before first imaginal exposure in PE.
Placebo: Placebo
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
34.6 years
n=99 Participants
|
29.9 years
n=107 Participants
|
32.4 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
12 participants
n=107 Participants
|
24 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: One week after drug visitThe primary outcome was trauma-cued heart rate reactivity a week after the drug visit as measured by the PTSD Brief Reactivity (PBR) task. For each patient, a 3-minute trauma script was constructed containing vivid details of the target trauma and used in tandem with a standard neutral script for baseline measurement. Heart rate reactivity for each time point was the beats per minute (BPM) difference between the neutral and trauma scripts represented as a slope.
Outcome measures
| Measure |
Yohimbine Group
n=14 Participants
Patients will take one 21.6 mg. dose of yohimbine one hour before first imaginal exposure in PE.
Yohimbine: alpha-2 adrenergic receptor antagonist
|
Placebo Group
n=12 Participants
Patients will take a placebo one hour before first imaginal exposure in PE.
Placebo: Placebo
|
|---|---|---|
|
Trauma-Cued Heart Rate Reactivity
|
71.01 beats per minute
Standard Error 3.84
|
75.08 beats per minute
Standard Error 3.11
|
SECONDARY outcome
Timeframe: 0 Weeks, 15 weeksThe CAPS is a structured interview for diagnosis of PTSD and is widely considered the gold-standard assessment. The CAPS produces a total score ranging from 0-136, with higher scores indicating more severe PTSD symptom severity. A 15-point decrease is considered clinically significant.
Outcome measures
| Measure |
Yohimbine Group
n=12 Participants
Patients will take one 21.6 mg. dose of yohimbine one hour before first imaginal exposure in PE.
Yohimbine: alpha-2 adrenergic receptor antagonist
|
Placebo Group
n=12 Participants
Patients will take a placebo one hour before first imaginal exposure in PE.
Placebo: Placebo
|
|---|---|---|
|
Change in Clinician Administered PTSD Scale (CAPS) Score
Baseline CAPS
|
67.33 units on a scale
Standard Deviation 24.49
|
65.00 units on a scale
Standard Deviation 13.01
|
|
Change in Clinician Administered PTSD Scale (CAPS) Score
Week 15 CAPS (post-treatment)
|
25.13 units on a scale
Standard Deviation 14.93
|
20.62 units on a scale
Standard Deviation 10.84
|
SECONDARY outcome
Timeframe: 0 weeks, 15 weeksThe PCL is a 17-item self-report measure of PTSD symptom severity based on the DSM-IV and has adequate psychometric properties. The PCL produces a score range between 17-85, with higher scores indicating more distress related to PTSD symptoms. A 10-point decrease on the PCL is considered clinically significant.
Outcome measures
| Measure |
Yohimbine Group
n=12 Participants
Patients will take one 21.6 mg. dose of yohimbine one hour before first imaginal exposure in PE.
Yohimbine: alpha-2 adrenergic receptor antagonist
|
Placebo Group
n=12 Participants
Patients will take a placebo one hour before first imaginal exposure in PE.
Placebo: Placebo
|
|---|---|---|
|
Change in Post Traumatic Stress Disorder Checklist (PCL) Score
Baseline PCL
|
64.00 units on a scale
Standard Deviation 12.49
|
60.25 units on a scale
Standard Deviation 14.53
|
|
Change in Post Traumatic Stress Disorder Checklist (PCL) Score
Week 15 PCL (post-treatment)
|
27.37 units on a scale
Standard Deviation 6.63
|
28.50 units on a scale
Standard Deviation 8.88
|
SECONDARY outcome
Timeframe: 0 weeks, 15 weeksThe BDI-II is a 21-item self-report measure that assesses depressive behavioral symptoms. It has demonstrated adequate psychometric validity, and external validity and is used widely as the dependent variable in treatment outcomes research. The BDI-II produces score ranges from 0-63, with higher scores indicating more severe depression symptom severity. A 5-point decrease on the BDI-II is considered clinically significant.
Outcome measures
| Measure |
Yohimbine Group
n=12 Participants
Patients will take one 21.6 mg. dose of yohimbine one hour before first imaginal exposure in PE.
Yohimbine: alpha-2 adrenergic receptor antagonist
|
Placebo Group
n=12 Participants
Patients will take a placebo one hour before first imaginal exposure in PE.
Placebo: Placebo
|
|---|---|---|
|
Change in Becks Depression Inventory (BDI-II) Score
Baseline BDI-II
|
30.56 units on a scale
Standard Deviation 13.10
|
22.62 units on a scale
Standard Deviation 7.05
|
|
Change in Becks Depression Inventory (BDI-II) Score
Week 15 BDI-II (post-treatment)
|
7.00 units on a scale
Standard Deviation 5.68
|
7.87 units on a scale
Standard Deviation 7.97
|
Adverse Events
Yohimbine Group
Placebo Group
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