Ignite Creation Date:
2024-05-05 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 9:53 AM
Study NCT ID:
NCT00725920
Status:
COMPLETED
Last Update Posted:
2014-08-26
First Post:
2008-07-28
Brief Title:
Placebo Controled Clinical Trial Using Topiramate To Treat Posttraumatic Stress Disorder PTSD Patients
Sponsor:
Federal University of São Paulo
Organization:
Federal University of São Paulo
Study Overview
Official Title:
Randomized Clinical Trial to Study the Topiramate Efficacy for Posttraumatic Disorder Treatment
Status:
COMPLETED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgday 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
Patients will receive topiramate or placebo the dose will start with 25 mgday 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None