Clonazepam and Paroxetine for Rapid Treatment of Post-Traumatic Stress Disorder

INCLUSION CRITERIA Patients with a primary diagnosis of Posttraumatic Stress Disorder according to DSM-IV (309.81) criteria with a duration of illness at least three months. Those with PTSD secondary to combat related trauma in Vietnam, Korea, or the Gulf will not be included. Subjects will be at least 18 years old. Those above age 65 years must be able to tolerate paroxetine starting dose of at least 20 mg daily and be without hepatic or renal impairment. Male and female subjects will be included. Patient must score greater than or equal to 50 on Clinician-Administered PTSD Scale (CAPS-2) at baseline as a measure of PTSD symptom severity. The patient must be able to give written informed consent prior to participation in this study. Patients who are not currently on medications for PTSD or major depression. Patients who are on other psychotropic drugs must have discontinued them for at least 1 week prior to randomization, and should not experience any current signs or symptoms of drug withdrawal. In addition, eligible patients must be in good physical health as confirmed by a complete physical exam (including normal vital signs), electrocardiogram, neurological exam, and routine laboratory tests of blood and urine. Subjects with PTSD and a prior history of alcohol dependence, in remission for at least six months. EXCLUSION CRITERIA Patients with any serious or unstable medical disorder or condition that would preclude the administration of paroxetine or clonazepam. Patients who would be unable to comply with study procedures or assessments. Patients engaged in compensation litigation whereby personal gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorder . Patients who meet DSM-IV criteria for substance abuse (alcohol or drugs) or substance dependence within 6 months prior to screening . Patients with the past or current history of alcohol and/or benzodiazepine dependence. Patients with a prolonged history (greater than 6 months) of intra venous drug abuse or dependence. Patients who are currently on fluoxetine or paroxetine and have not had a decrease in PTSD symptoms. Those who have had an adequate response of PTSD symptoms to psychotropic medications. Patients who are currently at high risk for homicide or suicide. Women of childbearing potential who are not practicing a clinically accepted method of contraception or who have a positive pregnancy test or who are lactating. Patients who have a history of allergic responses to benzodiazepines and or paroxetine.