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Changes of Cerebral Glucose Metabolism and After 12 Weeks of Escitalpram Treatment in Panic Disorder

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ClinicalTrials.gov Identifier: NCT00767871
Recruitment Status : Completed
First Posted : October 7, 2008
Last Update Posted : July 25, 2011
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by:
Samsung Medical Center

Tracking Information
First Submitted Date  ICMJE October 6, 2008
First Posted Date  ICMJE October 7, 2008
Last Update Posted Date July 25, 2011
Study Start Date  ICMJE March 2007
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2008)
18FDG-PET, PDSS & HAM-A [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00767871 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Changes of Cerebral Glucose Metabolism and After 12 Weeks of Escitalpram Treatment in Panic Disorder
Official Title  ICMJE Changes of Cerebral Glucose Metabolism Associated With the Fear Network Activity Before and After 12 Weeks of Escitalpram Treatment in Panic Disorder
Brief Summary

Panic disorder is one of the most prevalent psychiatric disorders and recently abnormal fear network is known to be implicated in the pathophysiology of panic disorder. The fear network involves many brain regions such as amygdala, hippocampus, periaqueductal gray (PAG), locus coeruleus, parahippocampal gyrus, frontal cortex, and thalamus. Escitalopram, a highly selective serotonin reuptake inhibitor, is usually effective for panic dis order, but there is little information on how escitalopram affects the fear network.

The specific aim of this study is to test the following hypotheses using 18F-FDG positron emission tomography (PET)

  1. Patients with panic disorder will show abnormal activity of the fear network compared to healthy comparison subjects.
  2. Patients with panic disorder will show normalized activity of the fear network after 12-weeks of treatment with escitalopram.
  3. The changes of fear work after the treatment will be associated with psychological variables and neurohormones.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Panic Disorder
Intervention  ICMJE Drug: Lexapro
12 week treatment with lexapro
Study Arms  ICMJE Experimental: Escitalopram
escitalopram (10-20mg) to panic patients
Intervention: Drug: Lexapro
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 21, 2011)
46
Original Estimated Enrollment  ICMJE
 (submitted: October 6, 2008)
20
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • panic disorder
  • 20-60 years

Exclusion Criteria:

  • history of major psychosis (schizophrenia or bipolar disorder), social phobia, obsessive-compulsive disorder, and generalized anxiety disorder, and posttraumatic stress disorder. The acceptable score on the 17-item Hamilton Depression Rating Scale at entry into the study will be less than 17.
  • patients and volunteers with alcohol dependence and current regular use of benzodiazepines will be excluded. Subjects with current or previous regular use of benzodiazepines will be excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00767871
Other Study ID Numbers  ICMJE SMCIRB2007-01-024
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bum-Hee Yu, M.D. Ph.D. / Professor, Department of Psychiatry, Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE H. Lundbeck A/S
Investigators  ICMJE
Principal Investigator: Bum-Hee Yu, M.D., Ph.D. Samsung Medical Center
PRS Account Samsung Medical Center
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP