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

NCT00725920 | Completed Phase 4 Results DMC

• 1 other identifier: TopirPTSD
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Posttraumatic Stress Disorder

Keywords

PTSD,; posttraumatic; stress; disorder,; randomization,; placebo,; controlled

Outcome Measures

Primary Outcomes (1)

• Clinician Administered Posttraumatic Stress Disorder Scale

  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.

  12 week

Study Arms (2)

Topiramate

EXPERIMENTAL

patients receiving the active drug: topiramate

Drug: Topiramate; Drug: placebo control group

Placebo Control group

PLACEBO COMPARATOR

patients received pills content placebo, that were identical to the pills content active drug

Drug: placebo control group

Interventions

Topiramate DRUG

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

Topiramate

placebo control group DRUG

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

Also known as: placebo

Placebo Control group; Topiramate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, 04023-061, Brazil

Location

Related Publications (1)

• 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.

  PMID: 19480669 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Disease

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Results Point of Contact

• Title: Marcelo F Mello
• Organization: Federal University of Sao Paulo

mf-mello@uol.com.br

55 11 50822860

Study Officials

• Marcelo F Mello, MD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 28, 2008
• First Posted: July 31, 2008
• Study Start: January 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 26, 2014
• Results First Posted: August 26, 2014

Record last verified: 2014-08

Locations

BR (1)