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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00767871
Other study ID # SMCIRB2007-01-024
Secondary ID
Status Completed
Phase Phase 4
First received October 6, 2008
Last updated July 21, 2011
Start date March 2007
Est. completion date December 2008

Study information

Verified date July 2011
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Other known NCT identifiers
  • NCT00461383

Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date December 2008
Est. primary completion date August 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 60 Years
Eligibility 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
Lexapro
12 week treatment with lexapro

Locations

Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (2)

Lead Sponsor Collaborator
Samsung Medical Center H. Lundbeck A/S

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 18FDG-PET, PDSS & HAM-A 12 weeks Yes
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