Trial Outcomes & Findings for Secondary Prevention With Paroxetine vs. Placebo in Subthreshold Posttraumatic Stress Disorder (PTSD) (NCT NCT00560612)
NCT ID: NCT00560612
Last Updated: 2019-06-18
Results Overview
Mean change scores in posttraumatic stress disorder symptoms. Raw scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered). A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms. The outcome measure is the change in scores before and after treatment. That is, the baseline and at 12 weeks difference scores.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
12 participants
Primary outcome timeframe
Change in Scores (12 weeks-Baseline)
Results posted on
2019-06-18
Participant Flow
Patient enrollment at the Durham VA Medical Center occurred from February 2006 until July 2008.
Participant milestones
| Measure |
Paroxetine
Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).
Week 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).
Week 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).
Week 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).
Week 12: Final study visit (no study medication dispensed).
|
Placebo
Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed).
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
7
|
|
Overall Study
COMPLETED
|
5
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Secondary Prevention With Paroxetine vs. Placebo in Subthreshold Posttraumatic Stress Disorder (PTSD)
Baseline characteristics by cohort
| Measure |
Paroxetine
n=5 Participants
Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).
Week 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).
Week 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).
Week 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).
Week 12: Final study visit (no study medication dispensed).
|
Placebo
n=7 Participants
Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed).
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
39.3 years
STANDARD_DEVIATION 4.73 • n=5 Participants
|
35.9 years
STANDARD_DEVIATION 9.69 • n=7 Participants
|
37.3 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change in Scores (12 weeks-Baseline)Mean change scores in posttraumatic stress disorder symptoms. Raw scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered). A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms. The outcome measure is the change in scores before and after treatment. That is, the baseline and at 12 weeks difference scores.
Outcome measures
| Measure |
Paroxetine
n=5 Participants
Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).
Week 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).
Week 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).
Week 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).
Week 12: Final study visit (no study medication dispensed).
|
Placebo
n=7 Participants
Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed).
|
|---|---|---|
|
Change in Clinician Administered PTSD Scale (CAPS) Scores
|
-3.40 Units on a scale
Standard Deviation 7.37
|
-5.00 Units on a scale
Standard Deviation 6.78
|
SECONDARY outcome
Timeframe: Change in Scores (12 weeks-Baseline)The SPRINT contains 8 questions which are rated on a 0-4 scale (0=not at all; 4=very much). The total score is computed from summing questions #1-8 (range=0-32). The higher the total score, the worse the symptoms. The outcome measure is the change in scores before and after treatment. That is, the baseline and Visit 6 difference scores.
Outcome measures
| Measure |
Paroxetine
n=5 Participants
Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).
Week 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).
Week 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).
Week 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).
Week 12: Final study visit (no study medication dispensed).
|
Placebo
n=7 Participants
Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed).
|
|---|---|---|
|
Change in Short PTSD Rating Interview Scores
|
-3.80 units on a scale
Standard Deviation 6.14
|
-2.00 units on a scale
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: Change in Scores (12 Weeks-Baseline)This scale measures resilience. Range of scores (0-100). A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience. The outcome measure is the change in scores before and after treatment. That is, the baseline and Visit 6 difference scores.
Outcome measures
| Measure |
Paroxetine
n=5 Participants
Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).
Week 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).
Week 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).
Week 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).
Week 12: Final study visit (no study medication dispensed).
|
Placebo
n=7 Participants
Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed).
|
|---|---|---|
|
Change in Connor Davidson Resilience Scale Scores
|
-0.80 units on a scale
Standard Deviation 11.67
|
-1.29 units on a scale
Standard Deviation 9.86
|
SECONDARY outcome
Timeframe: Change in Scores (12 Weeks-Baseline)The total HADS score is presented, which is regarded as a global measure of psychological distress. The total score ranges from 0-42. Each individual question is rated on a 4 point scale (0=absent to 3 =extreme presence). The higher the score, the greater level of psychological distress. The outcome measure is the change in scores before and after treatment. That is, the baseline and Visit 6 difference scores.
Outcome measures
| Measure |
Paroxetine
n=5 Participants
Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).
Week 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).
Week 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).
Week 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).
Week 12: Final study visit (no study medication dispensed).
|
Placebo
n=7 Participants
Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed).
|
|---|---|---|
|
Change in Hospital Anxiety and Depression Scale Scores
|
-3.40 units on a scale
Standard Deviation 2.70
|
-0.17 units on a scale
Standard Deviation 1.80
|
Adverse Events
Paroxetine
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Paroxetine
n=5 participants at risk
Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).
Week 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).
Week 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).
Week 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).
Week 12: Final study visit (no study medication dispensed).
|
Placebo
n=7 participants at risk
Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed).
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Decreased Appetite
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Decreased Interest in Sex
|
20.0%
1/5 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Dermatological
|
20.0%
1/5 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
1/5 • Number of events 1
|
28.6%
2/7 • Number of events 3
|
|
General disorders
Disorientation
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Drowsiness
|
0.00%
0/5
|
14.3%
1/7 • Number of events 2
|
|
General disorders
Dry Mouth
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Excitement/Agitation
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Headache
|
40.0%
2/5 • Number of events 2
|
0.00%
0/7
|
|
General disorders
Hypertension
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Impaired Sexual Performance
|
20.0%
1/5 • Number of events 5
|
0.00%
0/7
|
|
General disorders
Increased Appetite
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Insomnia
|
20.0%
1/5 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Joint Pain/Stiffness
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Malaise
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Nasal Congestion
|
20.0%
1/5 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Nausea
|
40.0%
2/5 • Number of events 3
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Restlessness
|
40.0%
2/5 • Number of events 2
|
0.00%
0/7
|
|
General disorders
Sweating
|
20.0%
1/5 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Syncope/Dizziness
|
20.0%
1/5 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Tinnitus
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Renal and urinary disorders
Urinary Retention
|
20.0%
1/5 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Vertigo
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place