Neuroprotective/Neurotrophic Effect of Lexapro® in Patients With Posttraumatic Stress Disorder

Study Overview
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Brief Summary
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The objectives of the current study are to evaluate the efficacy of escitalopram in treatment for post-traumatic stress disorder, to find the structural changes of brain using magnetic resonance imaging and its association with the symptoms reduction, and 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).

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

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Drug: escitalopram (lexapro)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 year-old male or female PTSD diagnosed by SCID-IV 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 MRI scan Any current psychotropic medication Unstable medical illness or severe abnormality in laboratory test at screening assessment Women who are pregnant, breastfeeding, or planning pregnancy Any contraindications to drug used in the study (e.g., allergy, intolerance, etc.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PTSD group<br> | Drug: escitalopram (lexapro)<br>* 0 - 4 week: 10 mg escitalopram a day 5 - 8 week: 20 mg escitalopram a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach |  | Baseline, 8th weeks | 
| Change from baseline in Clinician-administered PTSD scale scores at 1st week |  | Baseline, 1st week | 
| Change from baseline in Clinician-administered PTSD scale scores at 4th weeks |  | Baseline, 4th weeks | 
| Change from baseline in Clinician-administered PTSD scale scores at 8th weeks |  | Baseline, 8th weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Hamilton depression rating scale scores at 1st week |  | Baseline, 1st week | 
| Change from baseline in Hamilton anxiety rating scale scores at 1st week |  | Baseline, 1st week | 
| Number of participants with adverse events |  | 1st week | 
| Change from baseline in Hamilton depression rating scale scores at 4th weeks |  | Baseline, 4th weeks | 
| Change from baseline in Hamilton depression rating scale scores at 8th weeks |  | Baseline, 8th weeks | 
| Change from baseline in Hamilton anxiety rating scale scores at 4th weeks |  | Baseline, 4th weeks | 
| Change from baseline in Hamilton anxiety rating scale scores at 8th weeks |  | Baseline, 8th weeks | 
| Number of participants with adverse events |  | 4th weeks | 
| Number of participants with adverse events |  | 8th weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posttraumatic Stress Disorder, Escitalopram, Magnetic Resonance Imaging, BDNF