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Sentra AM® and Sentra PM® for Post-traumatic Stress Disorder (PTSD) and Gulf War Fibromyalgia (GWF) (GWF001)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stephanie Pavlik, Targeted Medical Pharma
ClinicalTrials.gov Identifier:
NCT01437891
First received: September 15, 2011
Last updated: February 2, 2012
Last verified: February 2012

September 15, 2011
February 2, 2012
September 2011
January 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01437891 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Sentra AM® and Sentra PM® for Post-traumatic Stress Disorder (PTSD) and Gulf War Fibromyalgia (GWF)
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

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Male and female military veterans age 18 to 75 experiencing moderate to severe PTSD symptoms including cognitive dysfunction, sleep disorders and mood disorders.

  • Post-traumatic Stress Disorder
  • Persian Gulf Syndrome
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
January 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. United States military veterans reporting PTSD and/or Gulf War Illness symptoms at least three months after return from duty.
  2. Men and non-pregnant, non-lactating women over the age of 18 and under the age of 75, able to read and understand English-language informed consent.
  3. Men and women of child-bearing potential willing to use adequate contraception, not to become pregnant or impregnate their partner for the study duration.
  4. Patients who will continue on a stable dose (no less than three months) of other medications they are taking and maintain the same dose throughout the duration of the study.
  5. Patients willing to commit to completing all clinical questionnaires and guidelines during study-related procedures.

Exclusion Criteria:

  1. Patients who have previously taken Sentra AM or Sentra PM.
  2. Patients not fluent in English.
  3. Participation in a clinical trial within one (1) month prior to screening.
  4. Uncontrolled or unstable serious cardiovascular, pulmonary, gastrointestinal, endocrine or neurologic disorder.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01437891
GWF001
No
Stephanie Pavlik, Targeted Medical Pharma
Stephanie Pavlik
Not Provided
Principal Investigator: William Shell, MD Targeted Medical Pharma, Inc.
Targeted Medical Pharma
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP