Topiramate in the Treatment of Post Traumatic Stress Disorder (PTSD)

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To study the potential therapeutic effects of topiramate (Topamax) in the treatment of PTSD.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tuscaloosa Research & Education Advancement Corporation
• Collaborator: Ortho-McNeil Janssen Scientific Affairs, LLC
• Treatments: Topiramate

Criteria

Inclusion Criteria:

• Diagnosis of PTSD DSM-IV criteria

• No substance abuse/dependence for the previous 2 months (except for nicotine and caffeine)

• Free of psychotropic medication, for 2 weeks (except 6 weeks for fluoxetine)

• Normal physical and laboratory examination (lab profile listed below)

• Negative urine screen for drugs of abuse

• Women of childbearing potential must be using nonpharmacologic medically approved methods of birth control

• Signed informed consent

• Male or female, any race or ethic origin

Exclusion Criteria:

• Lifetime history of bipolar, psychotic, or cognitive disorders

• Suicidal, homicidal, or psychotic

• Diagnosis of bulimia or anorexia nervosa

• History of sensitivity to topiramate

• General medical conditions or ongoing treatment that contraindicate the use of topiramate, such as seizure disorder or use of MAO inhibitors.

• Women planning to become pregnant or breastfeed during the study