Clinical trial NCT01437891: Sentra AM® and Sentra PM® for Post-traumatic Stress Disorder (PTSD) and Gulf War Fibromyalgia (GWF)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-traumatic Stress Disorder
Persian Gulf Syndrome
Keywords: PTSD
Military veteran
Gulf War
Fibromyalgia
Gulf War Syndrome
Lead sponsor: Targeted Medical Pharma
Sponsor class: INDUSTRY
First posted: 2011-09-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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-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.

Eligibility criteria: 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.

Primary outcomes:
measure: SF-36 general health survey
timeFrame: Baseline and Day 30
Secondary outcomes:
measure: Epworth Sleepiness Scale
timeFrame: Baseline and Day 30
measure: CERQ-short
timeFrame: Baseline and Day 30
measure: PCL-Military
timeFrame: Baseline and Day 30
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Targeted Medical Pharma
state: California
Study officials:
affiliation: Targeted Medical Pharma, Inc.
name: William Shell, MD
role: PRINCIPAL_INVESTIGATOR
References: