Placebo Controled Clinical Trial Using Topiramate To Treat Posttraumatic Stress Disorder (PTSD) Patients. (TOPIRAMATEPTSD)
Recruitment status was Recruiting
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 CAPS, BDI, BAI, SF-36 and SAS. the outcomes will be improvement on PTSD, Depression, Anxiety, quality of life and social adjustment scale according to scales above.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized Clinical Trial to Study the Topiramate Efficacy for Posttraumatic Disorder Treatment|
- Clinician Administered Posttraumatic Stress Disorder Scale [ Time Frame: 12 week ] [ Designated as safety issue: No ]
- SF-36 [ Time Frame: 12 week ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Estimated Study Completion Date:||July 2009|
|Estimated Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
patients receiving the active drug: topiramate
patients will receive the active drug
|Placebo Comparator: 2||
initial dose 25 mg day, increments of 25 mg each 2 weeks. Up to 100 mg/day Those with no intolerancy and no response dose could be up to 200 mg day
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: 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00725920
|Contact: Marcelo F Mello, MD||55 11 firstname.lastname@example.org|
|Contact: Mary S Yeh, MD||55 11 email@example.com|
|Federal University of Sao Paulo||Recruiting|
|Sao Paulo, Brazil, 04023-061|
|Contact: Mary S Yeh, MD 55 11 55 49 43 74 firstname.lastname@example.org|
|Contact: Marcelo F Mello, MD 55 11 30786829 email@example.com|
|Sub-Investigator: Mary S Yeh, firstname.lastname@example.org|
|Principal Investigator:||Marcelo F Mello, MD||Federal University of São Paulo|