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 Overview

• Status: Unknown
• Conditions: Posttraumatic Stress Disorder
• Intervention / Treatment: Drug: escitalopram (lexapro)

• Study Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: In Kyoon Lyoo, MD, PhD, MMS; Phone Number: +82-2-2072-3173; Email: inkylyoo@snu.ac.kr
    • Sub-Investigator: Jaeuk Hwang, MD, PhD
    • Sub-Investigator: Jieun E Kim, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PTSD group	Drug: escitalopram (lexapro); 0 - 4 week: 10 mg escitalopram a day 5 - 8 week: 20 mg escitalopram a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 4th weeks	Baseline, 4th weeks
Change from baseline in Clinician-administered PTSD scale scores at 8th weeks	Baseline, 8th weeks
Change from baseline in Clinician-administered PTSD scale scores at 1st week	Baseline, 1st week

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (ANTICIPATED): February 1, 2014
• Study Completion (ANTICIPATED): February 1, 2014

Study Registration Dates

• First Submitted: November 3, 2009
• First Submitted That Met QC Criteria: November 4, 2009
• First Posted (ESTIMATE): November 5, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): June 7, 2012
• Last Update Submitted That Met QC Criteria: June 6, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Magnetic Resonance Imaging; Posttraumatic Stress Disorder; BDNF; Escitalopram
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Trauma and Stressor Related Disorders; Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID Numbers: KR_12661A