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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
In Kyoon Lyoo, MD, PhD, MMS, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01008098
First received: November 3, 2009
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

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).

Condition Intervention Phase
Posttraumatic Stress Disorder
Drug: escitalopram (lexapro)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neuroprotective/Neurotrophic Effect of Lexapro® in Patients With Posttraumatic Stress Disorder

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach [ Time Frame: Baseline, 8th weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Clinician-administered PTSD scale scores at 1st week [ Time Frame: Baseline, 1st week ] [ Designated as safety issue: No ]
  • Change from baseline in Clinician-administered PTSD scale scores at 4th weeks [ Time Frame: Baseline, 4th weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Clinician-administered PTSD scale scores at 8th weeks [ Time Frame: Baseline, 8th weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in Hamilton depression rating scale scores at 1st week [ Time Frame: Baseline, 1st week ] [ Designated as safety issue: No ]
  • Change from baseline in Hamilton anxiety rating scale scores at 1st week [ Time Frame: Baseline, 1st week ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: 1st week ] [ Designated as safety issue: Yes ]
  • Change from baseline in Hamilton depression rating scale scores at 4th weeks [ Time Frame: Baseline, 4th weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Hamilton depression rating scale scores at 8th weeks [ Time Frame: Baseline, 8th weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Hamilton anxiety rating scale scores at 4th weeks [ Time Frame: Baseline, 4th weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Hamilton anxiety rating scale scores at 8th weeks [ Time Frame: Baseline, 8th weeks ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: 4th weeks ] [ Designated as safety issue: Yes ]
  • Number of participants with adverse events [ Time Frame: 8th weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 26
Study Start Date: November 2008
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PTSD group Drug: escitalopram (lexapro)
0 - 4 week: 10 mg escitalopram a day 5 - 8 week: 20 mg escitalopram a day

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01008098

Contacts
Contact: Junghyun H Lee, MD, MS 82-10-3453-1744 leejunghyun1@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: In Kyoon Lyoo, MD, PhD, MMS    +82-2-2072-3173    inkylyoo@snu.ac.kr   
Sub-Investigator: Jaeuk Hwang, MD, PhD         
Sub-Investigator: Jieun E Kim, MD, PhD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: In Kyoon Lyoo, MD, PhD, MMS Seoul National University Hospital
  More Information

No publications provided

Responsible Party: In Kyoon Lyoo, MD, PhD, MMS, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01008098     History of Changes
Other Study ID Numbers: KR_12661A
Study First Received: November 3, 2009
Last Updated: June 6, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Hospital:
Posttraumatic Stress Disorder
Escitalopram
Magnetic Resonance Imaging
BDNF

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Disease
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes
Citalopram
Dexetimide
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014