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Placebo Controled Clinical Trial Using Topiramate To Treat Posttraumatic Stress Disorder (PTSD) Patients.

Information source: Federal University of São Paulo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Posttraumatic Stress Disorder

Intervention: Topiramate (Drug); placebo control group (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Federal University of São Paulo

Official(s) and/or principal investigator(s):
Marcelo F Mello, MD, Principal Investigator, Affiliation: Federal University of São Paulo


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.

Clinical Details

Official title: Randomized Clinical Trial to Study the Topiramate Efficacy for Posttraumatic Disorder Treatment

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Clinician Administered Posttraumatic Stress Disorder Scale

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.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria:

- Outpatient, male and female 18 to 60 yrs old

- PTSD diagnostic according to DSM-IV criteria

- Patients who agree to receive diagnostic after SCID I application by a trained


- Sexually active female patients who agree to use contraceptive

- Patients who agree to sign the IRB approved informed consent

Exclusion Criteria:

- Patients who have schizophrenic disorder, delusional, psychotic depression,

schizo-affective, bipolar and dependence to psychoactive substance disorders

- Patients who have clinical disorders not compensated, which require clinical

treatment as priority

- Pregnancy

- Previous renal calculosis history

- Being under antidepressant, or other psychotropic medications

- BMI under 20.

Locations and Contacts

Federal University of Sao Paulo, Sao Paulo 04023-061, Brazil
Additional Information

Starting date: January 2007
Last updated: August 5, 2014

Page last updated: August 23, 2015

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