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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federal University of São Paulo
• Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Treatments: Topiramate

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.