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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00613067

Acronym

Enrollment

Registered

2008-02-12

Start date

2007-12-31

Completion date

2010-05-31

Last updated

2010-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Anxiety Disorder

Keywords

Generalized anxiety disorder, N100, Central serotonergic activity

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.

Interventions

DRUGescitalopram

* 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Event related potential (ERP) N100	Baseline

Secondary

Measure	Time frame
- HAMA - HAMD - CGI - Beck Anxiety Inventory(self rating)	baseline, 2, 4, 8 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026