ERP N1 as a Treatment Predictor of Generalized Anxiety Disorder

Generalized Anxiety Disorder Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00613067
• Other study ID #: IB-0709-053
• Status: Completed
• Phase: N/A
• First received: January 29, 2008
• Last updated: June 29, 2010
• Start date: December 2007
• Est. completion date: May 2010

Study information

• Verified date: June 2010
• Source: Inje University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Generalized Anxiety Disorder

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Psychiatry department, Inje Univ. Ilsanpaik Hospital	Goyang	Kyunggi

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Linka T, Müller 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. — View Citation

Linka T, Müller 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. — View Citation

Linka T, Sartory G, Bender S, Gastpar M, Müller 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. Epub 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event related potential (ERP) N100		Baseline
Secondary	- HAMA - HAMD - CGI - Beck Anxiety Inventory(self rating)		baseline, 2, 4, 8 weeks

External Links

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