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
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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Federal University of Sao Paulo, Sao Paulo 04023-061, Brazil
Additional Information
Starting date: January 2007
Last updated: August 5, 2014
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