CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 200 enrolled
Drug / intervention
Sertraline +1 moredrug
Likely dose
Sertraline up to 200 mg daily for 10 weeks; CBT 10 weekly sessionsAI-extracted
Key inclusion· 3
  • ✓DSM-IV diagnosis of PTSD
  • ✓Traumatic event occurred at least 12 weeks before study entry
  • ✓Willing to discontinue current CBT or antidepressant treatment
Key exclusion· 6
  • ✕Current schizophrenia or delusional disorder
  • ✕Medically unstable bipolar disorder, depression with psychotic features, or depression requiring psychiatric treatment
  • ✕Current alcohol or substance dependence within 3 months prior to study entry
  • ✕Ongoing intimate relationship with the perpetrator of the traumatic event

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00127673
NCT00127673Phase 3Completed
CompareCT.gov

Effectiveness of PTSD Treatment: CBT Versus Sertraline

Case Western Reserve University·interventional·Posted Aug 8, 2005·Updated May 24, 2022

In Brief

A Phase 3 clinical trial evaluating Sertraline and Cognitive behavioral therapy (CBT) for Post-Traumatic Stress Disorder. Completed, enrolled 200 participants across 1 site.

Detailed Summary

This study will compare the short- and long-term effectiveness of two different treatments for people with post-traumatic stress disorder.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost-Traumatic Stress Disorder
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 8, 2005
Enrollment StartSep 1, 2004
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 20.9 years ago

Interventions

Sertralinedrug

The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.

Cognitive behavioral therapy (CBT)behavioral

CBT will include 10 weekly sessions of individual cognitive behavioral therapy.