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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paroxetine | Active Comparator | Paroxetine 10 mg-40 mg or placebo; flexible dosing; 12-week duration. |
|
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paroxetine | Drug | Paroxetine 10 mg-40 mg or placebo; flexible dosing; 12-week duration. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change in Scores (12 weeks-Baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change in Scores (12 weeks-Baseline) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine E Marx, MD, MA | Durham VAMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham VAMC | Durham | North Carolina | 27705 | United States |
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Patient enrollment at the Durham VA Medical Center occurred from February 2006 until July 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Units on a scale | Change in Scores (12 weeks-Baseline) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Marx, MD | Durham VA Medical Center | 919 286-0411 | 7426 | marx0001@mc.duke.edu |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D017374 | Paroxetine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo |
| Drug |
Placebo: same as paroxetine (active comparator) |
|
| 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. | 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. | Change in Scores (12 Weeks-Baseline) |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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). |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Change in Scores (12 weeks-Baseline) |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Change in Scores (12 Weeks-Baseline) |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Change in Scores (12 Weeks-Baseline) |
|
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| 0 |
| 5 |
| 5 |
| 5 |
| EG001 | 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). | 0 | 7 | 5 | 7 |
| Decreased Appetite | General disorders | Systematic Assessment |
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| Decreased Interest in Sex | General disorders | Systematic Assessment |
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| Dermatological | General disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Disorientation | General disorders | Systematic Assessment |
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| Drowsiness | General disorders | Systematic Assessment |
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| Dry Mouth | General disorders | Systematic Assessment |
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| Excitement/Agitation | General disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Hypertension | General disorders | Systematic Assessment |
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| Impaired Sexual Performance | General disorders | Systematic Assessment |
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| Increased Appetite | General disorders | Systematic Assessment |
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| Insomnia | General disorders | Systematic Assessment |
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| Joint Pain/Stiffness | General disorders | Systematic Assessment |
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| Malaise | General disorders | Systematic Assessment |
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| Nasal Congestion | General disorders | Systematic Assessment |
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| Nausea | General disorders | Systematic Assessment |
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| Restlessness | General disorders | Systematic Assessment |
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| Sweating | General disorders | Systematic Assessment |
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| Syncope/Dizziness | General disorders | Systematic Assessment |
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| Tinnitus | General disorders | Systematic Assessment |
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| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
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| Vertigo | General disorders | Systematic Assessment |
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