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

NCT00767871 | Completed Phase 4 DMC

• 1 other identifier: SMCIRB2007-01-024
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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. 1.Patients with panic disorder will show abnormal activity of the fear network compared to healthy comparison subjects.
2. 2.Patients with panic disorder will show normalized activity of the fear network after 12-weeks of treatment with escitalopram.
3. 3.The changes of fear work after the treatment will be associated with psychological variables and neurohormones.

Conditions

Panic Disorder

Keywords

Panic disorder; PET; Escitaopram

Outcome Measures

Primary Outcomes (1)

• 18FDG-PET, PDSS & HAM-A

  12 weeks

Study Arms (1)

Escitalopram

EXPERIMENTAL

escitalopram (10-20mg) to panic patients

Drug: Lexapro

Interventions

Lexapro DRUG

12 week treatment with lexapro

Escitalopram

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• panic disorder
• years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead
• H. Lundbeck A/S: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Panic Disorder

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bum-Hee Yu, M.D., Ph.D.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 6, 2008
• First Posted: October 7, 2008
• Study Start: March 1, 2007
• Primary Completion: August 1, 2007
• Study Completion: December 1, 2008
• Last Updated: July 25, 2011

Record last verified: 2011-07

Locations

KR (1)