A Phase 4 interventional study of Paroxetine and Placebo in Stress Disorders, Post-Traumatic, sponsored by Durham VA Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2019-06-18.
Sponsored by Durham VA Medical Center · Phase 4, Interventional, and Prevention
The purpose of this study is: 1) To document the effectiveness and tolerability of paroxetine for the treatment of subthreshold posttraumatic stress disorder (PTSD) in veterans in the early post-deployment period; and 2) To determine the potential efficacy of paroxetine in preventing the progression of anxiety symptoms to PTSD and other anxiety disorders, and improving overall veteran function.
See brief summary
1,148 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.
This study's enrollment of 12 is below the median of 60 across 909 interventional studies indexed under Stress Disorders, Traumatic.
Browse Stress Disorders, Traumatic studies →Durham VA Medical Center is the lead sponsor of 18 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Paroxetine 10 mg-40 mg or placebo; flexible dosing; 12-week duration.
Drug: Paroxetine
Drug: Placebo
Paroxetine 10 mg-40 mg or placebo; flexible dosing; 12-week duration.
Placebo: same as paroxetine (active comparator)
Change in Clinician Administered PTSD Scale (CAPS) Scores
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.
Time frame: Change in Scores (12 weeks-Baseline)
Change in Short PTSD Rating Interview Scores
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.
Time frame: Change in Scores (12 weeks-Baseline)
Change in Connor Davidson Resilience Scale Scores
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.
Time frame: Change in Scores (12 Weeks-Baseline)
Change in Hospital Anxiety and Depression Scale Scores
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.
Time frame: Change in Scores (12 Weeks-Baseline)
Patient enrollment at the Durham VA Medical Center occurred from February 2006 until July 2008.
| Milestone | Paroxetine | Placebo |
|---|---|---|
| Started | 5 | 7 |
| Completed | 5 | 7 |
| Not completed | 0 | 0 |
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.
| Units on a scale | Paroxetine | Placebo |
|---|---|---|
| Change in Clinician Administered PTSD Scale (CAPS) Scores | -3.40 ± 7.37 | -5.00 ± 6.78 |
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.
| units on a scale | Paroxetine | Placebo |
|---|---|---|
| Change in Short PTSD Rating Interview Scores | -3.80 ± 6.14 | -2.00 ± 1.15 |
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.
| units on a scale | Paroxetine | Placebo |
|---|---|---|
| Change in Connor Davidson Resilience Scale Scores | -0.80 ± 11.67 | -1.29 ± 9.86 |
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.
| units on a scale | Paroxetine | Placebo |
|---|---|---|
| Change in Hospital Anxiety and Depression Scale Scores | -3.40 ± 2.70 | -0.17 ± 1.80 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Paroxetine | — | 0/5 (0%) | 5/5 (100%) |
| Placebo | — | 0/7 (0%) | 5/7 (71.4%) |
| Event | Paroxetine | Placebo |
|---|---|---|
| HeadacheGeneral disorders | 2/5 | 0/7 |
| NauseaGeneral disorders | 2/5 | 1/7 |
| RestlessnessGeneral disorders | 2/5 | 0/7 |
| DiarrheaGastrointestinal disorders | 1/5 | 2/7 |
| ConstipationGastrointestinal disorders | 1/5 | 1/7 |
| Decreased Interest in SexGeneral disorders | 1/5 | 0/7 |
| DermatologicalGeneral disorders | 1/5 | 0/7 |
| Impaired Sexual PerformanceGeneral disorders | 1/5 | 0/7 |
| InsomniaGeneral disorders | 1/5 | 1/7 |
| Nasal CongestionGeneral disorders | 1/5 | 0/7 |
| Age, Categorical(Participants) | Paroxetine | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 7 | 12 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Paroxetine | Placebo | Total |
|---|---|---|---|
| Mean | 39.3 ± 4.73 | 35.9 ± 9.69 | 37.3 ± 7.9 |
| Sex: Female, Male(Participants) | Paroxetine | Placebo | Total |
|---|---|---|---|
| Female | 1 | 1 | 2 |
| Male | 4 | 6 | 10 |
| Region of Enrollment(participants) | Paroxetine | Placebo | Total |
|---|---|---|---|
| United States | 5 | 7 | 12 |
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Durham VA Medical Center