Changes of Cerebral Glucose Metabolism and After 12 Weeks of Escitalpram Treatment in Panic Disorder
Primary Purpose
Panic Disorder
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lexapro
Sponsored by
About this trial
This is an interventional basic science trial for Panic Disorder focused on measuring Panic disorder, PET, Escitaopram
Eligibility Criteria
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.
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Escitalopram
Arm Description
escitalopram (10-20mg) to panic patients
Outcomes
Primary Outcome Measures
18FDG-PET, PDSS & HAM-A
Secondary Outcome Measures
Full Information
NCT ID
NCT00767871
First Posted
October 6, 2008
Last Updated
July 21, 2011
Sponsor
Samsung Medical Center
Collaborators
H. Lundbeck A/S
1. Study Identification
Unique Protocol Identification Number
NCT00767871
Brief Title
Changes of Cerebral Glucose Metabolism and After 12 Weeks of Escitalpram Treatment in Panic Disorder
Official Title
Changes of Cerebral Glucose Metabolism Associated With the Fear Network Activity Before and After 12 Weeks of Escitalpram Treatment in Panic Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Samsung Medical Center
Collaborators
H. Lundbeck A/S
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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)
Patients with panic disorder will show abnormal activity of the fear network compared to healthy comparison subjects.
Patients with panic disorder will show normalized activity of the fear network after 12-weeks of treatment with escitalopram.
The changes of fear work after the treatment will be associated with psychological variables and neurohormones.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder
Keywords
Panic disorder, PET, Escitaopram
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Escitalopram
Arm Type
Experimental
Arm Description
escitalopram (10-20mg) to panic patients
Intervention Type
Drug
Intervention Name(s)
Lexapro
Intervention Description
12 week treatment with lexapro
Primary Outcome Measure Information:
Title
18FDG-PET, PDSS & HAM-A
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bum-Hee Yu, M.D., Ph.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Changes of Cerebral Glucose Metabolism and After 12 Weeks of Escitalpram Treatment in Panic Disorder
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