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

Completed

Conditions studied: Post-traumatic Stress Disorder, Persian Gulf Syndrome

In brief

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).

Key facts

Study ID

NCT01437891

Run by

Stephanie Pavlik

People needed

30

Starts

2011-09-01

Expected to finish

2012-01-01

Last updated by the study team

2012-02-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Targeted Medical Pharma — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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