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ERP N1 as a Treatment Predictor of Generalized Anxiety Disorder

NCT ID: NCT00613067

Last Updated: 2010-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Generalized Anxiety Disorder

Keywords

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Generalized anxiety disorder N100 Central serotonergic activity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GAD

35 patients with Generalized Anxiety disorder

Group Type EXPERIMENTAL

escitalopram

Intervention Type DRUG

* 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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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lexapro

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inje University

OTHER

Sponsor Role lead

Responsible Party

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Department of Psychiatry, Inje Univ. Ilsanpaik Hospital

Principal Investigators

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Seung-Hwan Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Psychiatry department, Inje Univ. Ilsanpaik Hospital

Young-Min Park, MD, PhD

Role: STUDY_DIRECTOR

Psychiatry department, Inje Univ. Ilsanpaik Hospital

Sung-Man Bae, PhD

Role: STUDY_DIRECTOR

Psychiatry department, Inje Univ. Ilsanpaik Hospital

Locations

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Psychiatry department, Inje Univ. Ilsanpaik Hospital

Goyang, Kyunggi, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type RESULT
PMID: 15902586 (View on PubMed)

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.

Reference Type RESULT
PMID: 17316822 (View on PubMed)

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.

Reference Type RESULT
PMID: 15337269 (View on PubMed)

Other Identifiers

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IB-0709-053

Identifier Type: -

Identifier Source: org_study_id