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An open-label clinical outcomes study to determine the safety and efficacy of Sentra AM® and Sentra PM® for post-traumatic stress disorder (PTSD) and Gulf War fibromyalgia (GWF).
Male and female military veterans age 18 to 75 experiencing moderate to severe PTSD symptoms including cognitive dysfunction, sleep disorders and mood disorders.
Open-label internet questionnaire-based clinical outcomes study. 250 subjects. 60 days from enrollment initiation to completion and study close. Sentra AM- two capsules given orally once daily in the morning for 30 days. Sentra PM- two capsules given orally once daily thirty minutes before bedtime for 30 days.
To measure improvement in quality of life determined by the change in short form-36 (SF-36) general health survey.
Improvements in daytime sleepiness determined by the Epworth Sleepiness Scale (ESS), improvement in cognitive and emotional function using the Cognitive emotion regulation questionnaire - short (CERQ-Short), change in PTSD symptoms with the Primary Care - PTSD (PC-PTSD), Psychopathy Checklist- Military (PCL-M). Heart rate variability (HRV) data variation will be measured in a group of twenty subjects.
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| Measure | Description | Time Frame |
|---|---|---|
| SF-36 general health survey | A general health questionnaire to measure quality of life. Change from baseline. | Baseline and Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Epworth Sleepiness Scale | Improvements in daytime sleepiness determined by the Epworth Sleepiness Scale. | Baseline and Day 30 |
| CERQ-short | Assessment of cognitive function. Change from baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female military veterans age 18 to 75 experiencing moderate to severe PTSD symptoms including cognitive dysfunction, sleep disorders and mood disorders.
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| Name | Affiliation | Role |
|---|---|---|
| William Shell, MD | Targeted Medical Pharma, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Targeted Medical Pharma | Los Angeles | California | 90077 | United States |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D018923 | Persian Gulf Syndrome |
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D009784 | Occupational Diseases |
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| Baseline and Day 30 |
| PCL-Military | Changes in symptoms of military specific PTSD. | Baseline and Day 30 |
| D000067398 | War-Related Injuries |
| D014947 | Wounds and Injuries |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |