Back to resultsChanges of Cerebral Glucose Metabolism After 12 Weeks of Paroxetine Treatment in Panic Disorder
Primary Purpose
Panic Disorder
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Paxil CR
Sponsored by
About this trial
This is an interventional treatment trial for Panic Disorder focused on measuring panic disorder, paroxetine, PET
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, alcohol abuse and dependence, current regular use of benzodiazepines
- less than 17 on the HAM-D
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
paroxetine cr
Arm Description
single arm
Outcomes
Primary Outcome Measures
18FDG PET, PDSS & HAM-A
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00767754
Brief Title
Changes of Cerebral Glucose Metabolism After 12 Weeks of Paroxetine Treatment in Panic Disorder
Official Title
Phase 4 Study of Panic Disorder That Expresses to Change of Cerebral Glucose Metabolism After 12 Week of Paroxetine Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Panic disorder is one of the most prevalent and disabling psychiatric disorders. Brain regions such as amygdala, hippocampus, periaqueductal gray (PAG), locus coeruleus, parahippocampal gyrus, frontal cortex, and thalamus has been reported to be related with the pathophysiology and treatment outcome in panic disorder. Paroxetine has been used as primary agent for treatment of panic disorder but there is little information on how paroxetine affects the brain function in patients with panic disorder.
The specific aim of this study is to examine the differences in brain activity between responders and nonresponders and to determine the predictor of paroxetine treatment in patients with panic disorder in terms of brain activity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder
Keywords
panic disorder, paroxetine, PET
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
paroxetine cr
Arm Type
Other
Arm Description
single arm
Intervention Type
Drug
Intervention Name(s)
Paxil CR
Intervention Description
12 week treatment of Paxil(20-40mg)
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, alcohol abuse and dependence, current regular use of benzodiazepines
less than 17 on the HAM-D
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 After 12 Weeks of Paroxetine Treatment in Panic Disorder
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