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Completed

NCT Number: NCT00613067

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 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.

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Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders Mental Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychiatry department, Inje Univ. Ilsanpaik Hospital

Goyang, Kyunggi, 414-410, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Escitalopram

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

Other names: lexapro

Primary outcomes

  1. Event related potential (ERP) N100

    Time frame: Baseline

Secondary outcomes

  1. - HAMA - HAMD - CGI - Beck Anxiety Inventory(self rating)

    Time frame: baseline, 2, 4, 8 weeks

Sponsors and collaborators

Lead sponsor

Inje University

Other

Registry information

Official study title

The Amplitude Change of the Auditory Evoked N1 Component as a Predictor of Response to Escitalopram Treatment in Patients With Generalized Anxiety Disorder

Acronym: N1

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Feb 12, 2008
Registry last updated
Jun 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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