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

Posttraumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01008098
• Other study ID #: KR_12661A
• Status: Recruiting
• Phase: Phase 2
• First received: November 3, 2009
• Last updated: June 6, 2012
• Start date: November 2008
• Est. completion date: February 2014

Study information

• Verified date: June 2012
• Source: Seoul National University Hospital
• Contact: Junghyun H Lee, MD, MS
• Phone: 82-10-3453-1744
• Email: leejunghyun1[@]gmail.com
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• escitalopram (lexapro)
0 - 4 week: 10 mg escitalopram a day 5 - 8 week: 20 mg escitalopram a day

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach		Baseline, 8th weeks	No
Primary	Change from baseline in Clinician-administered PTSD scale scores at 1st week		Baseline, 1st week	No
Primary	Change from baseline in Clinician-administered PTSD scale scores at 4th weeks		Baseline, 4th weeks	No
Primary	Change from baseline in Clinician-administered PTSD scale scores at 8th weeks		Baseline, 8th weeks	No
Secondary	Change from baseline in Hamilton depression rating scale scores at 1st week		Baseline, 1st week	No
Secondary	Change from baseline in Hamilton anxiety rating scale scores at 1st week		Baseline, 1st week	No
Secondary	Number of participants with adverse events		1st week	Yes
Secondary	Change from baseline in Hamilton depression rating scale scores at 4th weeks		Baseline, 4th weeks	No
Secondary	Change from baseline in Hamilton depression rating scale scores at 8th weeks		Baseline, 8th weeks	No
Secondary	Change from baseline in Hamilton anxiety rating scale scores at 4th weeks		Baseline, 4th weeks	No
Secondary	Change from baseline in Hamilton anxiety rating scale scores at 8th weeks		Baseline, 8th weeks	No
Secondary	Number of participants with adverse events		4th weeks	Yes
Secondary	Number of participants with adverse events		8th weeks	Yes