Status:
COMPLETED
Placebo Controled Clinical Trial Using Topiramate To Treat Posttraumatic Stress Disorder (PTSD) Patients.
Lead Sponsor:
Federal University of São Paulo
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions:
Posttraumatic Stress Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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...
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 gr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00725920
Start Date
January 1 2007
End Date
December 1 2009
Last Update
August 26 2014
Active Locations (1)
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1
Federal University of Sao Paulo
São Paulo, São Paulo, Brazil, 04023-061