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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
History of Changes
  Purpose

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).


Condition
Post-traumatic Stress Disorder
Persian Gulf Syndrome

Study Type: Observational
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Targeted Medical Pharma:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 30
Study Start Date: September 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437891

Locations
United States, California
Targeted Medical Pharma
Los Angeles, California, United States, 90077
Sponsors and Collaborators
Stephanie Pavlik
Investigators
Principal Investigator: William Shell, MD Targeted Medical Pharma, Inc.
  More Information

Additional Information:
Study Summary and Registration - Web-based Study  This link exits the ClinicalTrials.gov site
Medication summary and description of science.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Stephanie Pavlik, Clinical Research Associate, Targeted Medical Pharma
ClinicalTrials.gov Identifier: NCT01437891     History of Changes
Other Study ID Numbers: GWF001
Study First Received: September 15, 2011
Last Updated: February 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Targeted Medical Pharma:
PTSD
Military veteran
Gulf War
Fibromyalgia
Gulf War Syndrome

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Persian Gulf Syndrome
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Anxiety Disorders
Mental Disorders
Occupational Diseases

ClinicalTrials.gov processed this record on May 19, 2013