Placebo Controled Clinical Trial Using Topiramate To Treat Posttraumatic Stress Disorder (PTSD) Patients.
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Seventy-two (72) patients will be randomly allocated, in a stratified manner, according to
      sex and comorbidity with depression, into two (2) groups: topiramate and routine clinical
      follow-up, and a group that would receive placebo pills and routine clinical follow-up. The
      patients will be submitted to evaluations by trained independent researchers, who will apply
      a structured clinical interview for DSM-IV in order to evaluate the presence of psychiatric
      disorders (SCID I and SCID-II); the scale of evaluation of the Impact Event Scale-IES; the
      frequency and intensity of the symptoms of PTSD and of the variations associated with the
      trauma (PTSD Scale administered by clinical personnel: "Clinician-Administered PTSD Scale" -
      CAPS); severity of depression: Beck Depression Inventory (BDI) and that of anxiety: Beck
      Anxiety Inventory (BAI); a scale for the evaluation of social adaptation: Social Adjustment
      Scale (SAS); a scale for the evaluation of Quality of Life: 36-Item Short Form Health Survey
      (SF-36) ; a scale for the evaluation of global functioning axis V of DSM-IV (AGF). The
      patients will receive active treatment for twelve (12) weeks. After this period, the patients
      who have been using topiramate and who have had an improvement in their clinical condition
      will continue to receive further treatment for another twelve (12) weeks. Patients will have
      their medication suspended after twenty four (24) weeks and will be followed-up for a further
      twenty four (24) weeks. Patients from the placebo group who showed improvement will continue
      to receive clinical follow-up for a further thirty six (36) weeks. Patients from the placebo
      group who showed a worsening in their clinical status, evaluated through the CGI, will be
      excluded from the study and sent for traditional treatment at the PROVE (Violence and Stress
      Program) clinic. Patients who terminated the active phase of the study who did not obtain a
      clinical improvement will be sent for traditional treatment at the PROVE clinic. The
      principal outcomes to be examined will be: Response (a decrease of 50% in the CAPS score
      starting from the baseline) and remission (lack of diagnostic criteria for PTSD in the CAPS).
      After the end of the treatment, the collected data will be tabulated and compared using
      parametric and non-parametric tests. In this study the validation of the CAPS scale for
      Portuguese will be carried out.
    

Intervention name(s): Topiramate; placebo control group
Intervention type(s): Drug; Drug
Intervention description(s): 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
Other intervention name(s): placebo
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD,; posttraumatic; stress; disorder,; randomization,; placebo,; controlled