Status:
COMPLETED
Sentra AM® and Sentra PM® for Post-traumatic Stress Disorder (PTSD) and Gulf War Fibromyalgia (GWF)
Lead Sponsor:
Stephanie Pavlik
Conditions:
Post-traumatic Stress Disorder
Persian Gulf Syndrome
Eligibility:
All Genders
18-75 years
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).
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-bas...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01437891
Start Date
September 1 2011
End Date
January 1 2012
Last Update
February 6 2012
Active Locations (1)
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1
Targeted Medical Pharma
Los Angeles, California, United States, 90077