Trial Outcomes & Findings for Augmentation Trial of Prazosin for Post-Traumatic Stress Disorder (PTSD) (NCT NCT00990106)
NCT ID: NCT00990106
Last Updated: 2018-05-23
Results Overview
Item B-2 "recurrent distressing dreams of the event" is a single item from the Clinician Administered PTSD Scale. The rating consists of two parts: Frequency and Intensity. Symptom frequency rated 0 to 4. Symptom intensity rated 0 to 4. Frequency plus Intensity ratings equal the total score. A higher score is worse; a lower score is better. This outcome measure evaluates the change in score from Baseline to Week 15.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
67 participants
Primary outcome timeframe
Baseline to Week 15
Results posted on
2018-05-23
Participant Flow
Participant milestones
| Measure |
Prazosin Hydrochloride
prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually.
|
Placebo
placebo: placebo titrated in the same manner as prazosin arm.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
35
|
|
Overall Study
COMPLETED
|
23
|
23
|
|
Overall Study
NOT COMPLETED
|
9
|
12
|
Reasons for withdrawal
| Measure |
Prazosin Hydrochloride
prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually.
|
Placebo
placebo: placebo titrated in the same manner as prazosin arm.
|
|---|---|---|
|
Overall Study
"too busy" to continue
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
opted for open label prazosin
|
1
|
1
|
|
Overall Study
relocation/deployment
|
4
|
1
|
|
Overall Study
started exclusionary medication
|
0
|
1
|
|
Overall Study
planned major surgery
|
0
|
1
|
|
Overall Study
scheduling conflicts
|
0
|
2
|
Baseline Characteristics
Augmentation Trial of Prazosin for Post-Traumatic Stress Disorder (PTSD)
Baseline characteristics by cohort
| Measure |
Prazosin Hydrochloride
n=32 Participants
prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually.
|
Placebo
n=35 Participants
placebo: placebo titrated in the same manner as prazosin arm.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.0 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
30.8 years
STANDARD_DEVIATION 6.5 • n=7 Participants
|
30.4 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
35 participants
n=7 Participants
|
67 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 15Population: Of the 67 subjects randomized, 46 completed the full 15 weeks (23 per group). The outcome data reports only those 46 participants who completed the full 15 weeks.
Item B-2 "recurrent distressing dreams of the event" is a single item from the Clinician Administered PTSD Scale. The rating consists of two parts: Frequency and Intensity. Symptom frequency rated 0 to 4. Symptom intensity rated 0 to 4. Frequency plus Intensity ratings equal the total score. A higher score is worse; a lower score is better. This outcome measure evaluates the change in score from Baseline to Week 15.
Outcome measures
| Measure |
Prazosin Hydrochloride
n=23 Participants
prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually.
|
Placebo
n=23 Participants
placebo: placebo titrated in the same manner as prazosin arm.
|
|---|---|---|
|
Change in Clinician Administered PTSD Scale for DSM-IV (CAPS) Recurrent Distressing Dreams Item
|
3.1 Scores on a Scale
Standard Error 0.3
|
1.2 Scores on a Scale
Standard Error 0.3
|
PRIMARY outcome
Timeframe: Baseline to Week 15Pittsburgh Sleep Quality Index is a self-report questionnaire assessing sleep quality and disturbances over a 1-month time interval. A global score is obtained by summing the seven component subscales (total score range: 0-21). A score of 5 or less indicates good sleep quality. A score of more than 5 indicates poor sleep quality. Change is measured from Baseline to Week 15.
Outcome measures
| Measure |
Prazosin Hydrochloride
n=23 Participants
prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually.
|
Placebo
n=23 Participants
placebo: placebo titrated in the same manner as prazosin arm.
|
|---|---|---|
|
Change in Pittsburgh Sleep Quality Index (PSQI)
|
5.6 Scores on a Scale
Standard Error 0.7 • Interval 12.8 to 15.5
|
2.8 Scores on a Scale
Standard Error 0.6 • Interval 7.1 to 9.9
|
PRIMARY outcome
Timeframe: Change from Baseline to Week 15Population: Of the 67 subjects randomized, 46 completed the full 15 weeks (23 per group). The outcome data reports only those 46 participants who completed the full 15 weeks.
The Clinical Global Impression of Change is a 7-point scale that rates global change compared to baseline (1=markedly improved, 2=moderately improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=moderately worse, 7=markedly worse). The CGIC is used to determine the impact of treat effects on meaningful and distinct change in overall sense of well-being and functioning. This outcome measures the proportion of responders who were rated markedly or moderately improved at Week 15 compared to Baseline.
Outcome measures
| Measure |
Prazosin Hydrochloride
n=23 Participants
prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually.
|
Placebo
n=23 Participants
placebo: placebo titrated in the same manner as prazosin arm.
|
|---|---|---|
|
Clinical Global Impression of Change (CGIC)
|
64 Percentage of responders
Interval 44.0 to 79.0
|
27 Percentage of responders
Interval 14.0 to 45.0
|
Adverse Events
Prazosin Hydrochloride
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prazosin Hydrochloride
n=32 participants at risk
prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually.
|
Placebo
n=35 participants at risk
placebo: placebo titrated in the same manner as prazosin arm.
|
|---|---|---|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/32
|
2.9%
1/35 • Number of events 1
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/32
|
2.9%
1/35 • Number of events 1
|
Other adverse events
| Measure |
Prazosin Hydrochloride
n=32 participants at risk
prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually.
|
Placebo
n=35 participants at risk
placebo: placebo titrated in the same manner as prazosin arm.
|
|---|---|---|
|
General disorders
syncope
|
6.2%
2/32 • Number of events 2
|
0.00%
0/35
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
21.9%
7/32 • Number of events 7
|
11.4%
4/35 • Number of events 4
|
|
General disorders
lack of energy
|
0.00%
0/32
|
2.9%
1/35 • Number of events 1
|
|
Cardiac disorders
palpitations
|
9.4%
3/32 • Number of events 3
|
2.9%
1/35 • Number of events 1
|
|
General disorders
drowsiness
|
3.1%
1/32 • Number of events 1
|
8.6%
3/35 • Number of events 3
|
|
Psychiatric disorders
depression
|
0.00%
0/32
|
5.7%
2/35 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
muscle weakness
|
6.2%
2/32 • Number of events 2
|
0.00%
0/35
|
|
General disorders
headache
|
3.1%
1/32 • Number of events 1
|
22.9%
8/35 • Number of events 8
|
|
General disorders
dizziness
|
28.1%
9/32 • Number of events 10
|
20.0%
7/35 • Number of events 7
|
|
Gastrointestinal disorders
nausea
|
15.6%
5/32 • Number of events 5
|
17.1%
6/35 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
rash
|
3.1%
1/32 • Number of events 1
|
0.00%
0/35
|
|
General disorders
other
|
56.2%
18/32 • Number of events 35
|
71.4%
25/35 • Number of events 42
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place