Trial Outcomes & Findings for Effectiveness of Propranolol For Treating People With Post-Traumatic Stress Disorder (NCT NCT00648375)
NCT ID: NCT00648375
Last Updated: 2020-01-02
Results Overview
Scores range from 0-70, higher scores represent more severe symptoms
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
12 participants
Primary outcome timeframe
Measured at Week 0, 2,4,6,8,10,12,14
Results posted on
2020-01-02
Participant Flow
12 subjects were screened for the study. 3 subjects met enrollment criteria and were randomized to study medication.
Participant milestones
| Measure |
Propranolol
Participants will take propranolol for 14 weeks.
Propanolol: Participants will take a 40-mg dose of propranolol immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.
Cognitive therapy workbook: Participants will also receive a cognitive behavioral therapy-based workbook in which they will track symptoms and efforts to use cognitive techniques to relieve symptoms each day.
|
Placebo
Participants will take placebo for 14 weeks.
Placebo: Participants will take a single dose of placebo immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.
Cognitive therapy workbook: Participants will also receive a cognitive behavioral therapy-based workbook in which they will track symptoms and efforts to use cognitive techniques to relieve symptoms each day.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Propranolol For Treating People With Post-Traumatic Stress Disorder
Baseline characteristics by cohort
| Measure |
Placebo
n=2 Participants
Participants will take placebo for 14 weeks.
Placebo: Participants will take a single dose of placebo immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.
Cognitive therapy workbook: Participants will also receive a cognitive behavioral therapy-based workbook in which they will track symptoms and efforts to use cognitive techniques to relieve symptoms each day.
|
Total
n=3 Participants
Total of all reporting groups
|
Propranolol
n=1 Participants
Participants will take propranolol for 14 weeks.
Propanolol: Participants will take a 40-mg dose of propranolol immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.
Cognitive therapy workbook: Participants will also receive a cognitive behavioral therapy-based workbook in which they will track symptoms and efforts to use cognitive techniques to relieve symptoms each day.
|
|---|---|---|---|
|
Age, Continuous
age
|
36.5 years
n=4 Participants
|
38.3 years
n=27 Participants
|
42 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=4 Participants
|
3 participants
n=27 Participants
|
1 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Measured at Week 0, 2,4,6,8,10,12,14Population: 3 subjects enrolled in the study and completed all study visits.
Scores range from 0-70, higher scores represent more severe symptoms
Outcome measures
| Measure |
Propranolol
n=1 Participants
Participants will take propranolol for 14 weeks.
Propanolol: Participants will take a 40-mg dose of propranolol immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.
Cognitive therapy workbook: Participants will also receive a cognitive behavioral therapy-based workbook in which they will track symptoms and efforts to use cognitive techniques to relieve symptoms each day.
|
Placebo
n=2 Participants
Participants will take placebo for 14 weeks.
Placebo: Participants will take a single dose of placebo immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.
Cognitive therapy workbook: Participants will also receive a cognitive behavioral therapy-based workbook in which they will track symptoms and efforts to use cognitive techniques to relieve symptoms each day.
|
|---|---|---|
|
Change in Severity of PTSD Symptoms Measured by Clinician Administered PTSD Scale for DSM-IV (CAPS-DX)
Week 4
|
56 score on a scale
Interval 56.0 to 56.0
|
49.5 score on a scale
Interval 45.0 to 54.0
|
|
Change in Severity of PTSD Symptoms Measured by Clinician Administered PTSD Scale for DSM-IV (CAPS-DX)
Week 6
|
45 score on a scale
Interval 45.0 to 45.0
|
44 score on a scale
Interval 40.0 to 48.0
|
|
Change in Severity of PTSD Symptoms Measured by Clinician Administered PTSD Scale for DSM-IV (CAPS-DX)
Week 8
|
40 score on a scale
Interval 40.0 to 40.0
|
45.5 score on a scale
Interval 36.0 to 55.0
|
|
Change in Severity of PTSD Symptoms Measured by Clinician Administered PTSD Scale for DSM-IV (CAPS-DX)
Week 10
|
32 score on a scale
Interval 32.0 to 32.0
|
35 score on a scale
Interval 30.0 to 40.0
|
|
Change in Severity of PTSD Symptoms Measured by Clinician Administered PTSD Scale for DSM-IV (CAPS-DX)
Baseline
|
58 score on a scale
Interval 58.0 to 58.0
|
59 score on a scale
Interval 55.0 to 63.0
|
|
Change in Severity of PTSD Symptoms Measured by Clinician Administered PTSD Scale for DSM-IV (CAPS-DX)
Week 2
|
62 score on a scale
Interval 62.0 to 62.0
|
60 score on a scale
Interval 58.0 to 62.0
|
|
Change in Severity of PTSD Symptoms Measured by Clinician Administered PTSD Scale for DSM-IV (CAPS-DX)
Week 12
|
29 score on a scale
Interval 29.0 to 29.0
|
35 score on a scale
Interval 18.0 to 52.0
|
|
Change in Severity of PTSD Symptoms Measured by Clinician Administered PTSD Scale for DSM-IV (CAPS-DX)
Week 14
|
27 score on a scale
Interval 27.0 to 27.0
|
28 score on a scale
Interval 16.0 to 40.0
|
SECONDARY outcome
Timeframe: Measured at Weeks 0,2,4,6,8,10,12, 14Population: 3 subjects were enrolled and randomized: one to active propranolol and two to placebo. Total number of subjects was too low to perform statistical analysis
Scores range from 0-30, higher scores represent more severe symptoms
Outcome measures
| Measure |
Propranolol
n=1 Participants
Participants will take propranolol for 14 weeks.
Propanolol: Participants will take a 40-mg dose of propranolol immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.
Cognitive therapy workbook: Participants will also receive a cognitive behavioral therapy-based workbook in which they will track symptoms and efforts to use cognitive techniques to relieve symptoms each day.
|
Placebo
n=2 Participants
Participants will take placebo for 14 weeks.
Placebo: Participants will take a single dose of placebo immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.
Cognitive therapy workbook: Participants will also receive a cognitive behavioral therapy-based workbook in which they will track symptoms and efforts to use cognitive techniques to relieve symptoms each day.
|
|---|---|---|
|
Change in Depression Measured by Beck Depression Inventory (BDI)
Baseline
|
12 score on a scale
Interval 12.0 to 12.0
|
13 score on a scale
Interval 10.0 to 16.0
|
|
Change in Depression Measured by Beck Depression Inventory (BDI)
Week 2
|
11 score on a scale
Interval 11.0 to 11.0
|
13 score on a scale
Interval 12.0 to 14.0
|
|
Change in Depression Measured by Beck Depression Inventory (BDI)
Week 6
|
9 score on a scale
Interval 9.0 to 9.0
|
9.5 score on a scale
Interval 8.0 to 11.0
|
|
Change in Depression Measured by Beck Depression Inventory (BDI)
Week 8
|
9 score on a scale
Interval 9.0 to 9.0
|
10 score on a scale
Interval 10.0 to 10.0
|
|
Change in Depression Measured by Beck Depression Inventory (BDI)
Week 10
|
7 score on a scale
Interval 7.0 to 7.0
|
7.5 score on a scale
Interval 7.0 to 8.0
|
|
Change in Depression Measured by Beck Depression Inventory (BDI)
Week 12
|
7 score on a scale
Interval 7.0 to 7.0
|
8.5 score on a scale
Interval 8.0 to 9.0
|
|
Change in Depression Measured by Beck Depression Inventory (BDI)
Week 14
|
6 score on a scale
Interval 6.0 to 6.0
|
7 score on a scale
Interval 6.0 to 8.0
|
|
Change in Depression Measured by Beck Depression Inventory (BDI)
Week 4
|
12 score on a scale
Interval 12.0 to 12.0
|
9.5 score on a scale
Interval 9.0 to 10.0
|
SECONDARY outcome
Timeframe: Measured at Weeks 0,2,4,6,8,10,12, 14Population: 3 subject were enrolled: 1 was randomized to propranolol and 2 were randomized to placebo.
This is a 17-item self-report scale. Scores range from 0-51, higher scores represent more severe symptoms.
Outcome measures
| Measure |
Propranolol
n=1 Participants
Participants will take propranolol for 14 weeks.
Propanolol: Participants will take a 40-mg dose of propranolol immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.
Cognitive therapy workbook: Participants will also receive a cognitive behavioral therapy-based workbook in which they will track symptoms and efforts to use cognitive techniques to relieve symptoms each day.
|
Placebo
n=2 Participants
Participants will take placebo for 14 weeks.
Placebo: Participants will take a single dose of placebo immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.
Cognitive therapy workbook: Participants will also receive a cognitive behavioral therapy-based workbook in which they will track symptoms and efforts to use cognitive techniques to relieve symptoms each day.
|
|---|---|---|
|
Change in Post-traumatic Scale-Self Score (PS-SR)
Baseline
|
36 score on a scale
Interval 36.0 to 36.0
|
42.5 score on a scale
Interval 40.0 to 45.0
|
|
Change in Post-traumatic Scale-Self Score (PS-SR)
Week 2
|
38 score on a scale
Interval 38.0 to 38.0
|
42.5 score on a scale
Interval 40.0 to 45.0
|
|
Change in Post-traumatic Scale-Self Score (PS-SR)
Week 4
|
38 score on a scale
Interval 38.0 to 38.0
|
36.5 score on a scale
Interval 34.0 to 39.0
|
|
Change in Post-traumatic Scale-Self Score (PS-SR)
Week 6
|
30 score on a scale
Interval 30.0 to 30.0
|
35.5 score on a scale
Interval 35.0 to 36.0
|
|
Change in Post-traumatic Scale-Self Score (PS-SR)
Week 8
|
28 score on a scale
Interval 28.0 to 28.0
|
32 score on a scale
Interval 28.0 to 36.0
|
|
Change in Post-traumatic Scale-Self Score (PS-SR)
Week 10
|
18 score on a scale
Interval 18.0 to 18.0
|
26.5 score on a scale
Interval 24.0 to 29.0
|
|
Change in Post-traumatic Scale-Self Score (PS-SR)
Week 14
|
17 score on a scale
Interval 17.0 to 17.0
|
20.5 score on a scale
Interval 12.0 to 29.0
|
|
Change in Post-traumatic Scale-Self Score (PS-SR)
Week 12
|
19 score on a scale
Interval 19.0 to 19.0
|
24 score on a scale
Interval 14.0 to 34.0
|
SECONDARY outcome
Timeframe: Measured at Weeks 0,2,4,6,8,10,12, 14Population: 3 subjects were randomized, one to propranolol and one to placebo. The total number of subjects was too low to perform statistical analysis.
BSI-SF is an 18 item scale used for a global score of general distress. Scores range from 0-72, higher scores represent more severe symptoms
Outcome measures
| Measure |
Propranolol
n=1 Participants
Participants will take propranolol for 14 weeks.
Propanolol: Participants will take a 40-mg dose of propranolol immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.
Cognitive therapy workbook: Participants will also receive a cognitive behavioral therapy-based workbook in which they will track symptoms and efforts to use cognitive techniques to relieve symptoms each day.
|
Placebo
n=2 Participants
Participants will take placebo for 14 weeks.
Placebo: Participants will take a single dose of placebo immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.
Cognitive therapy workbook: Participants will also receive a cognitive behavioral therapy-based workbook in which they will track symptoms and efforts to use cognitive techniques to relieve symptoms each day.
|
|---|---|---|
|
Change in Brief Symptoms Inventory-Short Form (BSI-SF)
Baseline
|
28 score on a scale
Interval 28.0 to 28.0
|
41 score on a scale
Interval 39.0 to 44.0
|
|
Change in Brief Symptoms Inventory-Short Form (BSI-SF)
Week 2
|
34 score on a scale
Interval 34.0 to 34.0
|
42 score on a scale
Interval 41.0 to 43.0
|
|
Change in Brief Symptoms Inventory-Short Form (BSI-SF)
Week 4
|
30 score on a scale
Interval 30.0 to 30.0
|
35 score on a scale
Interval 32.0 to 38.0
|
|
Change in Brief Symptoms Inventory-Short Form (BSI-SF)
Week 6
|
28 score on a scale
Interval 28.0 to 28.0
|
31 score on a scale
Interval 28.0 to 34.0
|
|
Change in Brief Symptoms Inventory-Short Form (BSI-SF)
Week 8
|
32 score on a scale
Interval 32.0 to 32.0
|
32 score on a scale
Interval 25.0 to 39.0
|
|
Change in Brief Symptoms Inventory-Short Form (BSI-SF)
Week 10
|
26 score on a scale
Interval 26.0 to 26.0
|
25 score on a scale
Interval 21.0 to 29.0
|
|
Change in Brief Symptoms Inventory-Short Form (BSI-SF)
Week 12
|
23 score on a scale
Interval 23.0 to 23.0
|
24.5 score on a scale
Interval 13.0 to 36.0
|
|
Change in Brief Symptoms Inventory-Short Form (BSI-SF)
Week 14
|
18 score on a scale
Interval 18.0 to 18.0
|
20 score on a scale
Interval 12.0 to 28.0
|
Adverse Events
Propranolol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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