Clinical Trial: Sentra AM® and Sentra PM® for Post-traumatic Stress Disorder (PTSD) and Gulf War Fibromyalgia (GWF)
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
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
Brief Summary: 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).
Detailed Summary:
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.
Sponsor: Stephanie Pavlik
Current Primary Outcome: SF-36 general health survey [ Time Frame: Baseline and Day 30 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Epworth Sleepiness Scale [ Time Frame: Baseline and Day 30 ]Improvements in daytime sleepiness determined by the Epworth Sleepiness Scale.
- CERQ-short [ Time Frame: Baseline and Day 30 ]Assessment of cognitive function. Change from baseline.
- PCL-Military [ Time Frame: Baseline and Day 30 ]Changes in symptoms of military specific PTSD.
Original Secondary Outcome: Same as current
Information By: Targeted Medical Pharma
Dates:
Date Received: September 15, 2011
Date Started: September 2011
Date Completion:
Last Updated: February 2, 2012
Last Verified: February 2012