NCT01008098

Brief Summary

The objectives of the current study are

  1. 1.to evaluate the efficacy of escitalopram in treatment for post-traumatic stress disorder,
  2. 2.to find the structural changes of brain using magnetic resonance imaging and its association with the symptoms reduction, and
  3. 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2008

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 3, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 5, 2009

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

June 7, 2012

Status Verified

June 1, 2012

Enrollment Period

5.3 years

First QC Date

November 3, 2009

Last Update Submit

June 6, 2012

Conditions

Posttraumatic Stress Disorder

Keywords

Posttraumatic Stress DisorderEscitalopramMagnetic Resonance ImagingBDNF

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (1)

PTSD group

EXPERIMENTAL
Drug: escitalopram (lexapro)

Interventions

escitalopram (lexapro)DRUG

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

PTSD group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • year-old male or female
  • PTSD diagnosed by SCID-IV

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • In Kyoon Lyoo, MD, PhD, MMS

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Junghyun H Lee, MD, MS

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 3, 2009

First Posted

November 5, 2009

Study Start

November 1, 2008

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

June 7, 2012

Record last verified: 2012-06

Locations

KR(1)