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...
Brief Summary
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: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: June 2011
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
Outcome Measures for this Clinical Trial
Primary Measures
- Brain T1 magnetic resonance imaging
- Time Frame: Baseline, 4, 12 week visits
Safety Issue?: No
- Time Frame: Baseline, 4, 12 week visits
- Clinician-administered PTSD scale
- Time Frame: baseline, 2,4,8,12 week visits
Safety Issue?: No
- Time Frame: baseline, 2,4,8,12 week visits
Secondary Measures
- Hamilton Depression Rating Scale
- Time Frame: baseline, 2,4,8,12 week visits
Safety Issue?: No
- Time Frame: baseline, 2,4,8,12 week visits
- Hamilton anxiety rating scale
- Time Frame: baseline, 2,4,8,12 week visits
Safety Issue?: No
- Time Frame: baseline, 2,4,8,12 week visits
- Adverse event check
- Time Frame: baseline, 2,4,8,12 week visits
Safety Issue?: Yes
- Time Frame: baseline, 2,4,8,12 week visits
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Seoul National University Hospital Other
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
Additional Information
Information obtained from ClinicalTrials.gov on February 02, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01008098
