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

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01008098
Enrollment
26
Registered
2009-11-05
Start date
2008-11-30
Completion date
2014-02-28
Last updated
2012-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorder

Keywords

Posttraumatic Stress Disorder, Escitalopram, Magnetic Resonance Imaging, BDNF

Brief 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).

Interventions

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

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.)

Design outcomes

Primary

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

Secondary

MeasureTime frame
Change from baseline in Hamilton depression rating scale scores at 8th weeksBaseline, 8th weeks
Change from baseline in Hamilton depression rating scale scores at 1st weekBaseline, 1st week
Change from baseline in Hamilton anxiety rating scale scores at 8th weeksBaseline, 8th weeks
Change from baseline in Hamilton anxiety rating scale scores at 4th weeksBaseline, 4th weeks
Change from baseline in Hamilton anxiety rating scale scores at 1st weekBaseline, 1st week
Number of participants with adverse events1st week
Change from baseline in Hamilton depression rating scale scores at 4th weeksBaseline, 4th weeks

Countries

South Korea

Contacts

Primary ContactJunghyun H Lee, MD, MS
leejunghyun1@gmail.com82-10-3453-1744

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026