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ERP N1 as a Treatment Predictor of Generalized Anxiety Disorder (N1)

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
escitalopram
Sponsored by
Inje University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Generalized anxiety disorder, N100, Central serotonergic activity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • DSM-IV TR for GAD
  • Hamilton Rating Scale for Anxiety (HAMA) >18
  • 18 to 75 years old

Exclusion Criteria:

  • Severe medical illness
  • Other psychiatric illness
  • HAMD > 18
  • High suicidal risk
  • pregnancy

Sites / Locations

  • Psychiatry department, Inje Univ. Ilsanpaik Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GAD

Arm Description

35 patients with Generalized Anxiety disorder

Outcomes

Primary Outcome Measures

Event related potential (ERP) N100

Secondary Outcome Measures

- HAMA - HAMD - CGI - Beck Anxiety Inventory(self rating)

Full Information

First Posted
January 29, 2008
Last Updated
June 29, 2010
Sponsor
Inje University
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1. Study Identification

Unique Protocol Identification Number
NCT00613067
Brief Title
ERP N1 as a Treatment Predictor of Generalized Anxiety Disorder
Acronym
N1
Official Title
The Amplitude Change of the Auditory Evoked N1 Component as a Predictor of Response to Escitalopram Treatment in Patients With Generalized Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Inje University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Amplitude changes of the N1 and the N1/P2 ERP component in response to different tone intensities have been suggested as a correlative of central serotonergic activity. A strong loudness dependence amplitude increase (strong intensity dependence) reflects low serotonergic neurotransmission and vice versa. Many researchers assumed that the brain serotonergic activity could influence treatment response of highly selective serotonin reuptake inhibitors in depression and anxiety disorders. There are a couple of studies reporting associations of N1 amplitude intensity dependence with response to Citalopram (positive correlation) and Reboxetine (negative correlation) treatment in major depressive disorder patients. But so far there have been no reports about associations between ERP N1 and antidepressant response in GAD patients. So, it would be very interesting to explore the correlations between ERP N1 amplitude change and the Escitalopram treatment responsiveness in GAD patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
Generalized anxiety disorder, N100, Central serotonergic activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GAD
Arm Type
Experimental
Arm Description
35 patients with Generalized Anxiety disorder
Intervention Type
Drug
Intervention Name(s)
escitalopram
Other Intervention Name(s)
lexapro
Intervention Description
Start with escitalopram 10mg According to patient's symptoms, stay on 10mg or increase up to 20mg Concomitant therapy : up to Xanax 0.5mg, or Ativan 1mg, not allowed above these dosages Length of washout period will be at least 2 weeks for any psychotropic drugs
Primary Outcome Measure Information:
Title
Event related potential (ERP) N100
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
- HAMA - HAMD - CGI - Beck Anxiety Inventory(self rating)
Time Frame
baseline, 2, 4, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: DSM-IV TR for GAD Hamilton Rating Scale for Anxiety (HAMA) >18 18 to 75 years old Exclusion Criteria: Severe medical illness Other psychiatric illness HAMD > 18 High suicidal risk pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-Hwan Lee, MD, PhD
Organizational Affiliation
Psychiatry department, Inje Univ. Ilsanpaik Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Young-Min Park, MD, PhD
Organizational Affiliation
Psychiatry department, Inje Univ. Ilsanpaik Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sung-Man Bae, PhD
Organizational Affiliation
Psychiatry department, Inje Univ. Ilsanpaik Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Psychiatry department, Inje Univ. Ilsanpaik Hospital
City
Goyang
State/Province
Kyunggi
ZIP/Postal Code
414-410
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
15902586
Citation
Linka T, Muller BW, Bender S, Sartory G, Gastpar M. The intensity dependence of auditory evoked ERP components predicts responsiveness to reboxetine treatment in major depression. Pharmacopsychiatry. 2005 May;38(3):139-43. doi: 10.1055/s-2005-864126.
Results Reference
result
PubMed Identifier
17316822
Citation
Linka T, Sartory G, Bender S, Gastpar M, Muller BW. The intensity dependence of auditory ERP components in unmedicated patients with major depression and healthy controls. An analysis of group differences. J Affect Disord. 2007 Nov;103(1-3):139-45. doi: 10.1016/j.jad.2007.01.018. Epub 2007 Feb 20.
Results Reference
result
PubMed Identifier
15337269
Citation
Linka T, Muller BW, Bender S, Sartory G. The intensity dependence of the auditory evoked N1 component as a predictor of response to Citalopram treatment in patients with major depression. Neurosci Lett. 2004 Sep 9;367(3):375-8. doi: 10.1016/j.neulet.2004.06.038.
Results Reference
result

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ERP N1 as a Treatment Predictor of Generalized Anxiety Disorder

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