At a glance
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Randomized Clinical Trial to Study the Topiramate Efficacy for Posttraumatic Disorder Treatment
In Brief
A Phase 4 clinical trial evaluating Topiramate and placebo control group for Posttraumatic Stress Disorder. Completed, enrolled 35 participants across 1 site.
Detailed Summary
The study is 12-week randomized placebo controlled trial compared to topiramate to treat patients with posttraumatic stress disorder, according to DSM-IV criteria. Patients will receive topiramate or placebo, the dose will start with 25 mg/day and every week 25mg will be increment according to patients tolerance to side effects. Patients will be evaluated by blind raters using Clinician-Administered PTSD Scale (CAPS), Beck Depression Inventory (BDI) , Beck Anxiety Inventory (BAI), 36-Item Short Form Health Survey (SF-36), Social Adjustment Scale (SAS). the outcomes will be improvement on Posttraumatic Stress Disorder (PTSD), Depression, Anxiety, quality of life and social adjustment scale according to scales above.
Study Details
Timeline
Interventions
patients will receive the active drug. The starting dose was 25 mg/day, with weekly increments of 25 mg/day, according to clinical status. The maximum dose considered was 200 mg/day
initial dose 25 mg day, increments of 25 mg each 2 weeks. Up to 100 mg/day Those with no intolerance and no response dose could be up to 200 mg day