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

Primary Purpose

Posttraumatic Stress Disorder

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
escitalopram (lexapro)
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Posttraumatic Stress Disorder, Escitalopram, Magnetic Resonance Imaging, BDNF

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PTSD group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline in Hamilton depression rating scale scores at 1st week
Change from baseline in Hamilton anxiety rating scale scores at 1st week
Number of participants with adverse events
Change from baseline in Hamilton depression rating scale scores at 4th weeks
Change from baseline in Hamilton depression rating scale scores at 8th weeks
Change from baseline in Hamilton anxiety rating scale scores at 4th weeks
Change from baseline in Hamilton anxiety rating scale scores at 8th weeks
Number of participants with adverse events
Number of participants with adverse events

Full Information

First Posted
November 3, 2009
Last Updated
June 6, 2012
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01008098
Brief Title
Neuroprotective/Neurotrophic Effect of Lexapro® in Patients With Posttraumatic Stress Disorder
Official Title
Neuroprotective/Neurotrophic Effect of Lexapro® in Patients With Posttraumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
February 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
Posttraumatic Stress Disorder, Escitalopram, Magnetic Resonance Imaging, BDNF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PTSD group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
escitalopram (lexapro)
Intervention Description
0 - 4 week: 10 mg escitalopram a day 5 - 8 week: 20 mg escitalopram a day
Primary Outcome Measure Information:
Title
Changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach
Time Frame
Baseline, 8th weeks
Title
Change from baseline in Clinician-administered PTSD scale scores at 1st week
Time Frame
Baseline, 1st week
Title
Change from baseline in Clinician-administered PTSD scale scores at 4th weeks
Time Frame
Baseline, 4th weeks
Title
Change from baseline in Clinician-administered PTSD scale scores at 8th weeks
Time Frame
Baseline, 8th weeks
Secondary Outcome Measure Information:
Title
Change from baseline in Hamilton depression rating scale scores at 1st week
Time Frame
Baseline, 1st week
Title
Change from baseline in Hamilton anxiety rating scale scores at 1st week
Time Frame
Baseline, 1st week
Title
Number of participants with adverse events
Time Frame
1st week
Title
Change from baseline in Hamilton depression rating scale scores at 4th weeks
Time Frame
Baseline, 4th weeks
Title
Change from baseline in Hamilton depression rating scale scores at 8th weeks
Time Frame
Baseline, 8th weeks
Title
Change from baseline in Hamilton anxiety rating scale scores at 4th weeks
Time Frame
Baseline, 4th weeks
Title
Change from baseline in Hamilton anxiety rating scale scores at 8th weeks
Time Frame
Baseline, 8th weeks
Title
Number of participants with adverse events
Time Frame
4th weeks
Title
Number of participants with adverse events
Time Frame
8th weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junghyun H Lee, MD, MS
Phone
82-10-3453-1744
Email
leejunghyun1@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In Kyoon Lyoo, MD, PhD, MMS
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
In Kyoon Lyoo, MD, PhD, MMS
Phone
+82-2-2072-3173
Email
inkylyoo@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Jaeuk Hwang, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jieun E Kim, MD, PhD

12. IPD Sharing Statement

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

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