Phase 4 N=35 Randomized Triple-blind Treatment

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

Posttraumatic Stress Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00725920 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2014

Primary outcome: Primary: Clinician Administered Posttraumatic Stress Disorder Scale — 30.41; 35.78 Total CAPS score — p=0.0076

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Topiramate (Drug); placebo control group (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Federal University of São Paulo
Primary completion: Nov 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Clinician Administered Posttraumatic Stress Disorder Scale	30.41; 35.78	0.0076 sig

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00725920). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.