Neuroprotective/Neurotrophic Effect of Lexapro® in Patients With Posttraumatic Stress Disorder
- Registration Number
- NCT01008098
- Lead Sponsor
- Seoul National University Hospital
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 26
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PTSD group escitalopram (lexapro) -
- Primary Outcome Measures
Name Time Method Change from baseline in Clinician-administered PTSD scale scores at 1st week Baseline, 1st week 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
- Secondary Outcome Measures
Name Time Method 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 8th weeks 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
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of