Changes of Cerebral Glucose Metabolism and After 12 Weeks of Escitalpram Treatment in Panic Disorder - Full Text View

Sponsor:	Samsung Medical Center
Collaborator:	H. Lundbeck A/S
Information provided by:	Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT00767871

Purpose

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.

Condition	Intervention	Phase
Panic Disorder	Drug: Lexapro	Phase IV

Study Type:	Interventional
Study Design:	Basic Science, Open Label, Single Group Assignment
Official Title:	Changes of Cerebral Glucose Metabolism Associated With the Fear Network Activity Before and After 12 Weeks of Escitalpram Treatment in Panic Disorder

Resource links provided by NLM:

MedlinePlus related topics: Panic Disorder

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:

18FDG-PET, PDSS & HAM-A [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	March 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Escitalopram: Experimental escitalopram (10-20mg) to panic patients	Drug: Lexapro 12 week treatment with lexapro

Eligibility

Ages Eligible for Study:	20 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00767871

Contacts

Contact: Eun-Ho Kang, M.D.

+82-3410-1384

psychotx@naver.com

Locations

Korea, Republic of
Samsung Medical Center	Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Eun-Ho Kang, M.D. +82-3410-1384 psychotx@naver.com

Sponsors and Collaborators

Samsung Medical Center

H. Lundbeck A/S

Investigators

Principal Investigator:

Bum-Hee Yu, M.D., Ph.D.

Samsung Medical Center

More Information

No publications provided

Responsible Party:	Department of Psychiatry, Samsung Medical Center ( Bum-Hee Yu, M.D. Ph.D. / Professor )
Study ID Numbers:	SMCIRB2007-01-024
Study First Received:	October 6, 2008
Last Updated:	October 6, 2008
ClinicalTrials.gov Identifier:	NCT00767871 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:

Panic disorder
PET
Escitaopram

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Citalopram
Serotonin Uptake Inhibitors
Pharmacologic Actions

Panic Disorder
Serotonin Agents
Pathologic Processes
Anxiety Disorders
Mental Disorders
Therapeutic Uses
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 27, 2009