ERP N1 as a Treatment Predictor of 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...
Brief Summary
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”
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.
- Study Type: Interventional
- Study Design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: April 2010
Intervention(s) in this Clinical Trial
- 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
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: GAD
- 35 patients with Generalized Anxiety disorder
Outcome Measures for this Clinical Trial
Primary Measures
- Event related potential (ERP) N100
- Time Frame: Baseline
Safety Issue?: No
- Time Frame: Baseline
Secondary Measures
- - HAMA - HAMD - CGI - Beck Anxiety Inventory(self rating)
- Time Frame: baseline, 2, 4, 8 weeks
Safety Issue?: No
- Time Frame: baseline, 2, 4, 8 weeks
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 75 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Inje University Other
Overall Clinical Trial Officials and Contacts
Seung-Hwan Lee, MD, PhD Principal Investigator Psychiatry department, Inje Univ. Ilsanpaik Hospital
Related Publications
Citations Reporting Results
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.
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 2007 Feb 20.
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.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00613067
Study ID Number: IB-0709-053
ClinicalTrials.gov Identifier: NCT00613067
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00613067
