Topiramate in the Treatment of Posttraumatic Stress Disorder in Civilians

Exclusion Criteria

• •1. Subjects who have a DSM-IV diagnosis of substance dependence or abuse (with the exception of nicotine or caffeine dependence) within the past 3 months.
• •2. Subjects with a current or past history of primary major depressive disorder or major anxiety disorder (i.e., panic disorder, obsessive-compulsive disorder, social phobia) as defined by DSM-IV.
• •3. Subjects with a current or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder as defined by DSM-IV.
• •4. Subjects with a DSM-IV diagnosis of current organic mental disorder, factitious disorder, or malingering.
• •5. Subjects who are currently enrolled in a cognitive-behavioral therapy program.
• •Note: Subjects may be receiving concurrent psychotherapy (other than cognitive-behavioral therapy), but subjects must not initiate new psychotherapy treatment during their participation in the trial.
• •6. Subjects with prior non-response to topiramate for the treatment of PTSD following an adequate trial.
• •7. Subjects with a disability or other compensation claim pending for lack of functioning due to PTSD.
• •8. Subjects with disability compensation dependent on persisting functional impairment related to PTSD.
• •9. Subjects who have previously been treated with topiramate and discontinued treatment due to an adverse event or subjects with a known hypersensitivity to topiramate.
• •10. Subjects with clinically unstable disease: cardiovascular, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease that could interfere with their participation in the study.
• •11. Subjects with a history of nephrolithiasis.
• •12. Subjects who have SGOT and/or SGPT levels greater than 2 times the upper limit of the normal range at Screening.
• •13. Subjects who have active liver disease.
• •14. Subjects taking antipsychotics within three months of the screening visit.
• •15. Subjects with progressive or degenerative neurologic disorders (e.g., multiple sclerosis).