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

Seoul National University Hospital26 enrolled

Overview

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Posttraumatic Stress Disorder

Interventions

escitalopram (lexapro)DRUG

0 - 4 week: 10 mg escitalopram a day 5 - 8 week: 20 mg escitalopram a day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.)

Locations (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach

Time frame: Baseline, 8th weeks

Change from baseline in Clinician-administered PTSD scale scores at 1st week

Time frame: Baseline, 1st week

Change from baseline in Clinician-administered PTSD scale scores at 4th weeks

Time frame: Baseline, 4th weeks

Change from baseline in Clinician-administered PTSD scale scores at 8th weeks

Time frame: Baseline, 8th weeks

Secondary Outcomes

Change from baseline in Hamilton depression rating scale scores at 1st week

Time frame: Baseline, 1st week

Change from baseline in Hamilton anxiety rating scale scores at 1st week

Time frame: Baseline, 1st week

Number of participants with adverse events

Time frame: 1st week

Change from baseline in Hamilton depression rating scale scores at 4th weeks

Time frame: Baseline, 4th weeks

Change from baseline in Hamilton depression rating scale scores at 8th weeks

Time frame: Baseline, 8th weeks

Change from baseline in Hamilton anxiety rating scale scores at 4th weeks

Time frame: Baseline, 4th weeks

Central Contacts

Junghyun H Lee, MD, MS

CONTACT

82-10-3453-1744 leejunghyun1@gmail.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.