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

Post-traumatic Stress Disorder Clinical Trial

— GWF001  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01437891
• Other study ID #: GWF001
• Status: Completed
• Phase: N/A
• First received: September 15, 2011
• Last updated: February 2, 2012
• Start date: September 2011
• Est. completion date: January 2012

Study information

• Verified date: February 2012
• Source: Targeted Medical Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Persian Gulf Syndrome
• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Locations

Country	Name	City	State
United States	Targeted Medical Pharma	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Stephanie Pavlik

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SF-36 general health survey	A general health questionnaire to measure quality of life. Change from baseline.	Baseline and Day 30	No
Secondary	Epworth Sleepiness Scale	Improvements in daytime sleepiness determined by the Epworth Sleepiness Scale.	Baseline and Day 30	No
Secondary	CERQ-short	Assessment of cognitive function. Change from baseline.	Baseline and Day 30	No
Secondary	PCL-Military	Changes in symptoms of military specific PTSD.	Baseline and Day 30	No