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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:
ClinicalTrials.gov Identifier:
NCT01437891
First Posted: September 21, 2011
Last Update Posted: February 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stephanie Pavlik, Targeted Medical Pharma
  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:


Further study details as provided by Stephanie Pavlik, Targeted Medical Pharma:

Primary Outcome Measures:
  • SF-36 general health survey [ Time Frame: Baseline and Day 30 ]
    A general health questionnaire to measure quality of life. Change from baseline.


Secondary Outcome Measures:
  • 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.


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


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

Responsible Party: Stephanie Pavlik, Clinical Research Associate, Targeted Medical Pharma
ClinicalTrials.gov Identifier: NCT01437891     History of Changes
Other Study ID Numbers: GWF001
First Submitted: September 15, 2011
First Posted: September 21, 2011
Last Update Posted: February 6, 2012
Last Verified: February 2012

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

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Fibromyalgia
Myofascial Pain Syndromes
Stress Disorders, Post-Traumatic
Persian Gulf Syndrome
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Occupational Diseases