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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00725920
Recruitment Status : Completed
First Posted : July 31, 2008
Results First Posted : August 26, 2014
Last Update Posted : August 26, 2014
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Marcelo Feijo Mello, Federal University of São Paulo

July 28, 2008
July 31, 2008
June 1, 2010
August 26, 2014
August 26, 2014
January 2007
November 2009   (Final data collection date for primary outcome measure)
Clinician Administered Posttraumatic Stress Disorder Scale [ Time Frame: 12 week ]

The Clinician-Administered PTSD Scale (CAPS) [33] : is a structured interview developed to diagnose PTSD and rate its severity. It is comprised of 30-items to assess PTSD-related symptom frequency and severity. Total scores (sum of 3 clusters items) range from 0 to 136, with scores classified as follows: subclinical, from 0 to 19; mild, from 20 to 39; moderate, from 40 to 59; severe, from 60 to 79; extreme, 80 and above.

CAPS has 3 subscales characterized by the sum of all symptoms for each cluster: CAPS 1 (Revivesce/intrusive recolllections, 5 symptoms, score range: 0-28); CAPS 2 (avoidance, 7 symptoms, score range: 0-36); and CAPS 3 (hyperarousal, 5 symptoms, score range: 0-28).

CAPS scoring: each symptom scores range from 0 to 4, plus 0-2 scores for frequency, and 0-2 severity.

Clinician Administered Posttraumatic Stress Disorder Scale [ Time Frame: 12 week ]
Complete list of historical versions of study NCT00725920 on Archive Site
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SF-36 [ Time Frame: 12 week ]
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Placebo Controled Clinical Trial Using Topiramate To Treat Posttraumatic Stress Disorder (PTSD) Patients.
Randomized Clinical Trial to Study the Topiramate Efficacy for Posttraumatic Disorder Treatment

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.

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.
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Posttraumatic Stress Disorder
  • Drug: Topiramate
    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
  • Drug: placebo control group
    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 Name: placebo
  • Experimental: Topiramate
    patients receiving the active drug: topiramate
    • Drug: Topiramate
    • Drug: placebo control group
  • Placebo Comparator: Placebo Control group
    patients received pills content placebo, that were identical to the pills content active drug
    Intervention: Drug: placebo control group
Mello MF, Yeh MS, Barbosa Neto J, Braga LL, Fiks JP, Mendes DD, Moriyama TS, Valente NL, Costa MC, Mattos P, Bressan RA, Andreoli SB, Mari JJ. A randomized, double-blind, placebo-controlled trial to assess the efficacy of topiramate in the treatment of post-traumatic stress disorder. BMC Psychiatry. 2009 May 29;9:28. doi: 10.1186/1471-244X-9-28.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2009
November 2009   (Final data collection date for primary outcome measure)

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 psychiatrist
  • 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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Marcelo Feijo Mello, Federal University of São Paulo
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Principal Investigator: Marcelo F Mello, MD Federal University of São Paulo
Federal University of São Paulo
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP