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ERP N1 as a Treatment Predictor of Generalized Anxiety Disorder

This study has been completed.
Sponsor:
Information provided by:
Inje University
ClinicalTrials.gov Identifier:
NCT00613067
First received: January 29, 2008
Last updated: June 29, 2010
Last verified: June 2010
History of Changes

January 29, 2008
June 29, 2010
December 2007
April 2010   (final data collection date for primary outcome measure)
Event related potential (ERP) N100 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00613067 on ClinicalTrials.gov Archive Site
- HAMA - HAMD - CGI - Beck Anxiety Inventory(self rating) [ Time Frame: baseline, 2, 4, 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
ERP N1 as a Treatment Predictor of Generalized Anxiety Disorder
The Amplitude Change of the Auditory Evoked N1 Component as a Predictor of Response to Escitalopram Treatment in Patients With Generalized Anxiety Disorder

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.
Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Generalized Anxiety Disorder
Drug: escitalopram
  • 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
Other Name: lexapro
Experimental: GAD
35 patients with Generalized Anxiety disorder
Intervention: Drug: escitalopram

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
May 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00613067
IB-0709-053
No
Seung-Hwan Lee, Department of Psychiatry, Inje Univ. Ilsanpaik Hospital
Inje University
Not Provided
Principal Investigator: Seung-Hwan Lee, MD, PhD Psychiatry department, Inje Univ. Ilsanpaik Hospital
Study Director: Young-Min Park, MD, PhD Psychiatry department, Inje Univ. Ilsanpaik Hospital
Study Director: Sung-Man Bae, PhD Psychiatry department, Inje Univ. Ilsanpaik Hospital
Inje University
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP