View Clinical Trial (Medical Research Study)
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
| City: |
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Los Angeles |
| State: |
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California |
| Zip Code: |
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90077 |
| Conditions: |
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Post-traumatic Stress Disorder - Persian Gulf Syndrome |
| Purpose: |
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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.
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| Study Summary: |
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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 SF-36 general health
survey.
Improvements in daytime sleepiness determined by the Epworth Sleepiness Scale, improvement
in cognitive and emotional function using the Cognitive emotion regulation questionnaire -
short, change in PTSD symptoms with the Primary Care - PTSD, Psychopathy Checklist-
Military. Heart rate variability data variation will be measured in a group of twenty
subjects.
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| Criteria: |
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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.
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| NCT ID: |
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NCT01437891 |
| Primary Contact: |
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Stephanie Pavlik
Phone: 310-913-1120
Email: subjectinquiry@ptlcentral.com
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| Backup Contact: |
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Email: marcusch@ptlcentral.com
Marcus Charuvastra
Phone: 310-474-9809
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| Location Contact: |
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Los Angeles, California 90077
United States
Stephanie Pavlik
Phone: 310-913-1120
Email: subjectinquiry@ptlcentral.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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