Clinical trial NCT01008098: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Posttraumatic Stress Disorder
Keywords: Posttraumatic Stress Disorder
Escitalopram
Magnetic Resonance Imaging
BDNF
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2009-11-05
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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.)

Primary outcomes:
measure: Changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach
timeFrame: Baseline, 8th weeks
measure: Change from baseline in Clinician-administered PTSD scale scores at 1st week
timeFrame: Baseline, 1st week
measure: Change from baseline in Clinician-administered PTSD scale scores at 4th weeks
timeFrame: Baseline, 4th weeks
measure: Change from baseline in Clinician-administered PTSD scale scores at 8th weeks
timeFrame: Baseline, 8th weeks
Secondary outcomes:
measure: Change from baseline in Hamilton depression rating scale scores at 1st week
timeFrame: Baseline, 1st week
measure: Change from baseline in Hamilton anxiety rating scale scores at 1st week
timeFrame: Baseline, 1st week
measure: Number of participants with adverse events
timeFrame: 1st week
measure: Change from baseline in Hamilton depression rating scale scores at 4th weeks
timeFrame: Baseline, 4th weeks
measure: Change from baseline in Hamilton depression rating scale scores at 8th weeks
timeFrame: Baseline, 8th weeks
measure: Change from baseline in Hamilton anxiety rating scale scores at 4th weeks
timeFrame: Baseline, 4th weeks
measure: Change from baseline in Hamilton anxiety rating scale scores at 8th weeks
timeFrame: Baseline, 8th weeks
measure: Number of participants with adverse events
timeFrame: 4th weeks
measure: Number of participants with adverse events
timeFrame: 8th weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: In Kyoon Lyoo, MD, PhD, MMS
role: PRINCIPAL_INVESTIGATOR
References: