Official Title: “Neuroprotective/Neurotrophic Effect of Lexapro® in Patients With Posttraumatic Stress Disorder”

The objectives of the current study are

1. to evaluate the efficacy of escitalopram in treatment for post-traumatic stress disorder,

2. to find the structural changes of brain using magnetic resonance imaging and its association with the symptoms reduction, and

3. to look at the differences of brain imaging findings and symptoms changes according to genetic differences of brain-derived neurotrophic factor (a biological molecule facilitating neuronal growth in human).

Study Type: Interventional

Study Design: Control: Uncontrolled, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Study Primary Completion Date: November 2010

Intervention(s) in this Clinical Trial

• Drug: escitalopram (lexapro)
  • 0 - 4 week: 10 mg escitalopram a day 5 - 12 week: 20 mg escitalopram a day

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: PTSD group

Primary Measures

• Brain T1 magnetic resonance imaging
  • Time Frame: Baseline, 4, 12 week visits
    Safety Issue?: No
• Clinician-administered PTSD scale
  • Time Frame: baseline, 2,4,8,12 week visits
    Safety Issue?: No

Secondary Measures

• Hamilton Depression Rating Scale
  • Time Frame: baseline, 2,4,8,12 week visits
    Safety Issue?: No
• Hamilton anxiety rating scale
  • Time Frame: baseline, 2,4,8,12 week visits
    Safety Issue?: No
• Adverse event check
  • Time Frame: baseline, 2,4,8,12 week visits
    Safety Issue?: Yes

Inclusion Criteria:

• 18-50 year-old male or female
• PTSD diagnosed by SCID-IV
• Traumatic event in recent 6 months

Exclusion Criteria:

• Previous or current treatment history for PTSD
• Neurologic disease (eg., epilepsy, infarct, multiple sclerosis, brain tumor)
• Any other axis I psychiatric disorder diagnosed by SCID-IV
• Borderline personality disorder or antisocial personality disorder
• IQ below 80
• Any contraindication to and MR scan
• any current psychotropic medication

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Seoul National University Hospital

Overall Clinical Trial Officials and Contacts

In Kyoon Lyoo, MD, PhD Principal Investigator Seoul National University Hospital  

Overall Contact: In Kyoon Lyoo, MD, PhD +82-2-2072-2302 inkylyoo@snu.ac.kr

Information obtained from ClinicalTrials.gov on September 01, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01008098

Study ID Number: KR_12661A

ClinicalTrials.gov Identifier: NCT01008098

Health Authority: Korea: Food and Drug Administration