Sentra AM® and Sentra PM® for Post-traumatic Stress Disorder (PTSD) and Gulf War Fibromyalgia (GWF) (GWF001)
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).
Post-traumatic Stress Disorder
Persian Gulf Syndrome
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||An Open-label Clinical Outcomes Study to Determine the Safety and Efficacy of Sentra AM® and Sentra PM® for Post-traumatic Stress Disorder and Gulf War Fibromyalgia|
- SF-36 general health survey [ Time Frame: Baseline and Day 30 ] [ Designated as safety issue: No ]A general health questionnaire to measure quality of life. Change from baseline.
- Epworth Sleepiness Scale [ Time Frame: Baseline and Day 30 ] [ Designated as safety issue: No ]Improvements in daytime sleepiness determined by the Epworth Sleepiness Scale.
- CERQ-short [ Time Frame: Baseline and Day 30 ] [ Designated as safety issue: No ]Assessment of cognitive function. Change from baseline.
- PCL-Military [ Time Frame: Baseline and Day 30 ] [ Designated as safety issue: No ]Changes in symptoms of military specific PTSD.
|Study Start Date:||September 2011|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
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.
|United States, California|
|Targeted Medical Pharma|
|Los Angeles, California, United States, 90077|
|Principal Investigator:||William Shell, MD||Targeted Medical Pharma, Inc.|