Emory University researchers in the Trauma and Anxiety Recovery Program (TARP) are participating in a research study involving the investigational medicine, risperidone, to determine whether it will improve the response of treatment-resistant Post-Traumatic Stress Disorder (PTSD) symptoms. Although two antidepressant medications are approved to treat PTSD, responses to the medications have been modest.
Risperidone, an atypical antipsychotic, has been approved by the Food and Drug Administration for the treatment of psychotic disorders, but is still considered investigational for the purposes of this study. Risperidone has been shown to be effective when combined with certain antidepressant medications for treatment resistant depression. Individuals with PTSD often experience anxiety attacks, nightmares, or repeated unwanted memories after experiencing or witnessing life-threatening events, such as serious accidents or natural disasters, or traumatic events such as physical or sexual abuse.
Researchers are seeking healthy adults between the ages of 18 and 65 who have had symptoms of non-combat-related PTSD for at least a month. Participation in the study lasts for 16 weeks and requires weekly or biweekly study appointments ranging from 15 to 45 minutes. Interested individuals will be evaluated at a screening visit that includes a physical exam and a review of their emotional, psychiatric, and substance abuse histories in order to determine eligibility. Participants will receive the psychiatric and medical evaluations at no cost.
All qualified participants will be started on sertraline (i.e. Zoloft) for eight weeks. Patients who are still symptomatic at the end of this phase, will be invited to join the second portion of the study where they will be randomly assigned to receive risperidone or placebo (sugar pill) in addition to the sertraline.
Participants will be monitored regularly for medication effects, adverse events, and PTSD symptoms. At the conclusion of the study, the patient's dosage will either be gradually decreased until they are no longer on the medication(s), or they will be maintained on their medication(s) under the supervision of their primary care physicians or psychiatrists.
Interested persons can contact Nicole Berkebile, study coordinator, at the Trauma and Anxiety Recovery Program of Emory University at (404) 778-TARP (8277). All information will be kept confidential.