Clinical trial to investigate new treatment for post traumatic stress disorder

January 17, 2002

Georgetown University Medical Center is conducting a clinical trial to assess the effectiveness of venlafaxine HCI, marketed as Effexor XR, on post traumatic stress disorder (PTSD). The drug is currently approved by the Food and Drug Administration for treatment of generalized anxiety disorder and depression, but not PTSD. Symptoms of PTSD include disturbed sleep, flashbacks, an increased heart rate, heavy sweating, and avoidance of activities that remind the person of the traumatic event.

"Many people suffered shock and grief following the events of September 11," said David M. Goldstein, MD, professor of psychiatry and principal investigator of this project. "People who are still suffering from the aftereffects of this tragedy may have PTSD and could benefit from treatment."

Goldstein and his research team will compare the results of three treatment options during a 15-week trial. One group of patients will receive Effexor; the second group will be prescribed sertraline HCL, marketed by Pfizer Pharmaceuticals as Zoloft. Zoloft is FDA-approved for treatment of PTSD. A third group will receive a placebo, or sugar pill.

Effexor, whose manufacturer, Wyeth Ayerst, is funding the Georgetown study, works by increasing levels of two brain chemicals, serotonin and norepinephrine; Zoloft and many other antidepressants raise levels of serotonin alone. A deficiency of these two chemicals is believed to be a possible cause of PTSD (as well as depression and anxiety).

This clinical trial, part of a nationwide study being conducted by Wyeth Ayerst, will involve 500 participants nationwide, with 10 to 20 at Georgetown. To qualify for the study, participants must be 18 years of age or older, have experienced symptoms of PTSD for at least six months, and meet several other requirements.

"Even those who do not fall within the strict criteria of this study still have many treatment options that they may explore here at Georgetown or elsewhere," Goldstein said. "Georgetown's Mood and Anxiety Disorders Clinic treats people suffering from a wide variety of conditions such as depression, anxiety and PTSD, and our staff members and clinicians can help them select an appropriate treatment option."
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For more information about this clinical trial, call Barbara Wolff, RN, at 202-687-8804 or Emma Thembani at 202-687-6355.

Georgetown University Medical Center includes the nationally ranked School of Medicine, School of Nursing and Health Studies, the Lombardi Cancer Center and a biomedical research enterprise. For more information, visit http://www.georgetown.edu/gumc.

Georgetown University Medical Center

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