Posttraumatic Stress DisorderPhase 2NCT01008098
Neuroprotective/Neurotrophic Effect of Lexapro® in Patients With Posttraumatic Stress Disorder
A Phase 2 study testing escitalopram (lexapro) in people with Posttraumatic Stress Disorder, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- escitalopram (lexapro)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2008to Feb 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 year-old male or female
- PTSD diagnosed by SCID-IV
Who cannot join
- 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
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- 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.)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
In Kyoon Lyoo, MD, PhD, MMS, +82-2-2072-3173, inkylyoo@snu.ac.kr
Jaeuk Hwang, MD, PhD
About this study
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).
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- escitalopram (lexapro)
- Keywords
- Posttraumatic Stress Disorder, Escitalopram, Magnetic Resonance Imaging, BDNF
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
escitalopram (lexapro)Drug
0 - 4 week: 10 mg escitalopram a day 5 - 8 week: 20 mg escitalopram a day
| Study group | Role | What they receive |
|---|---|---|
| PTSD group | Experimental | Not described Receives: Drug: escitalopram (lexapro) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach
Measured: Baseline, 8th weeks
Change from baseline in Clinician-administered PTSD scale scores at 1st week
Measured: Baseline, 1st week
Change from baseline in Clinician-administered PTSD scale scores at 4th weeks
Measured: Baseline, 4th weeks
Change from baseline in Clinician-administered PTSD scale scores at 8th weeks
Measured: Baseline, 8th weeks
Secondary outcomes (9)
Change from baseline in Hamilton depression rating scale scores at 1st week
Measured: Baseline, 1st week
Change from baseline in Hamilton anxiety rating scale scores at 1st week
Measured: Baseline, 1st week
Number of participants with adverse events
Measured: 1st week
Change from baseline in Hamilton depression rating scale scores at 4th weeks
Measured: Baseline, 4th weeks
Change from baseline in Hamilton depression rating scale scores at 8th weeks
Measured: Baseline, 8th weeks
Change from baseline in Hamilton anxiety rating scale scores at 4th weeks
Measured: Baseline, 4th weeks
Change from baseline in Hamilton anxiety rating scale scores at 8th weeks
Measured: Baseline, 8th weeks
Number of participants with adverse events
Measured: 4th weeks
Number of participants with adverse events
Measured: 8th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2009 (estimated)
- Study startNov 2008
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In Kyoon Lyoo, MD, PhD, MMS, Seoul National University Hospital
- Investigators
- In Kyoon Lyoo, MD, PhD, MMS, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008098
- Sponsor's protocol ID
- KR_12661A
- Status last verified
- Jun 2012
- First submitted
- 3 Nov 2009
- Last updated
- 7 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroprotective/Neurotrophic Effect of Lexapro® in Patients With Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT01008098
- Acronym / sponsor ID
- KR_12661A
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Posttraumatic Stress Disorder, Escitalopram, Magnetic Resonance Imaging, BDNF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 5 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PTSD group | Experimental | Drug: escitalopram (lexapro) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-65 year-old male or female
- PTSD diagnosed by SCID-IV
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| escitalopram (lexapro)0 - 4 week: 10 mg escitalopram a day 5 - 8 week: 20 mg escitalopram a day | Drug | PTSD group |
Primary outcome
Changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach
Time frame: Baseline, 8th weeks
Change from baseline in Clinician-administered PTSD scale scores at 1st week
Time frame: Baseline, 1st week
Change from baseline in Clinician-administered PTSD scale scores at 4th weeks
Time frame: Baseline, 4th weeks
Change from baseline in Clinician-administered PTSD scale scores at 8th weeks
Time frame: Baseline, 8th weeks
9 secondary outcomes
Change from baseline in Hamilton depression rating scale scores at 1st week
Time frame: Baseline, 1st week
Change from baseline in Hamilton anxiety rating scale scores at 1st week
Time frame: Baseline, 1st week
Number of participants with adverse events
Time frame: 1st week
Change from baseline in Hamilton depression rating scale scores at 4th weeks
Time frame: Baseline, 4th weeks
Change from baseline in Hamilton depression rating scale scores at 8th weeks
Time frame: Baseline, 8th weeks
Change from baseline in Hamilton anxiety rating scale scores at 4th weeks
Time frame: Baseline, 4th weeks
Change from baseline in Hamilton anxiety rating scale scores at 8th weeks
Time frame: Baseline, 8th weeks
Number of participants with adverse events
Time frame: 4th weeks
Number of participants with adverse events
Time frame: 8th weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In Kyoon Lyoo, MD, PhD, MMS principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing escitalopram (lexapro) in people with Posttraumatic Stress Disorder, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junghyun H Lee, MD, MS (82-10-3453-1744, leejunghyun1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach (time frame: Baseline, 8th weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2012.