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

NCT01437891 | Completed

• 1 other identifier: GWF001
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Post-traumatic Stress Disorder; Persian Gulf Syndrome

Keywords

PTSD; Military veteran; Gulf War; Fibromyalgia; Gulf War Syndrome

Outcome Measures

Primary Outcomes (1)

• SF-36 general health survey

  A general health questionnaire to measure quality of life. Change from baseline.

  Baseline and Day 30

Secondary Outcomes (3)

• Epworth Sleepiness Scale

  Baseline and Day 30

• CERQ-short

  Baseline and Day 30

• PCL-Military

  Baseline and Day 30

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• United States military veterans reporting PTSD and/or Gulf War Illness symptoms at least three months after return from duty.
• 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.
• Men and women of child-bearing potential willing to use adequate contraception, not to become pregnant or impregnate their partner for the study duration.
• 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.
• Patients willing to commit to completing all clinical questionnaires and guidelines during study-related procedures.

You may not qualify if:

• Patients who have previously taken Sentra AM or Sentra PM.
• Patients not fluent in English.
• Participation in a clinical trial within one (1) month prior to screening.
• Uncontrolled or unstable serious cardiovascular, pulmonary, gastrointestinal, endocrine or neurologic disorder.

Sponsors & Collaborators

• Stephanie Pavlik: lead

Study Sites (1)

Targeted Medical Pharma

Los Angeles, California, 90077, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Persian Gulf Syndrome; Fibromyalgia

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Occupational Diseases; War-Related Injuries; Wounds and Injuries; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• William Shell, MD

  Targeted Medical Pharma, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Associate

Study Record Dates

• First Submitted: September 15, 2011
• First Posted: September 21, 2011
• Study Start: September 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: February 6, 2012

Record last verified: 2012-02

Locations

US (1)