George E. Wahlen
Department of Veterans Affairs Medical Center
VA Salt Lake City Health Care System
500 Foothill Drive
Salt Lake City, UT 84148
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Re: Research Study for PTSD
Dear Veteran,
The George E. Wahlen Department of Veterans Affairs Salt Lake City Health Care System in conjunction with VA Cooperative Studies program is conducting an IRB approved research study to determine if a medication is effective in helping to treat symptoms of PTSD. (IRB stands for Institutional Review Boards. IRBs are designed to protect study participants. They review and must approve the action plan for every clinical trial. ed.)
All subjects in the study will receive supportive care during their research related visits by the research team and study medication for six months. During the length of the study one-half of the subjects will receive study medication and the other half will receive a placebo. All study participants will design an alternative treatment plan with their doctor and will identify other medications in the event they have an inadequate response (feel they are taking the placebo) or cannot tolerate the study medication. In most instances participants may remain on other medications to treat PTSD/Depression while involved in this research study, however there are some exclusions.
The study will involve subjects participating in psychological assessments every six weeks as well as filling out various self-assessment forms in addition to continuing usual care appointments at the hospital. Following a two week screening period, eligible subjects will be enrolled in this six month treatment study. Participants in the study will be reimbursed $20 for visits at weeks 4, 8, 16 and 20 and $50 for visits at weeks 6, 12 and 24 for a maximum total payment of $230. Payments will only be made after weeks 12 and 24.
The study subjects will also have the opportunity to be involved in a genetics sub-study; however this is not a requirement to participate. Study subjects will be asked to participate to help in identifying a genetic profile that may respond more positively to Risperidone and also to help determine if genetics plays a role in the susceptibility of demonstrating symptoms of PTSD.
Please feel free to call me or your care provider at the hospital if you have any questions. I can be reached at (801) 582-1565, ext. 1836 or call toll free (800) 613-4012.
Respectfully,
Lindsay L. Carpenter
Research Coordinator
VA Salt Lake City Health Care System