Sentra AM® and Sentra PM® for Post-traumatic Stress Disorder (PTSD) and Gulf War Fibromyalgia (GWF) (GWF001)
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|ClinicalTrials.gov Identifier: NCT01437891|
Recruitment Status : Completed
First Posted : September 21, 2011
Last Update Posted : February 6, 2012
|Condition or disease|
|Post-traumatic Stress Disorder Persian Gulf Syndrome|
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.
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Observational Model:||Case Control|
|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|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
- SF-36 general health survey [ Time Frame: Baseline and Day 30 ]A general health questionnaire to measure quality of life. Change from baseline.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01437891
|United States, California|
|Targeted Medical Pharma|
|Los Angeles, California, United States, 90077|
|Principal Investigator:||William Shell, MD||Targeted Medical Pharma, Inc.|