ERP N1 as a Treatment Predictor of Generalized Anxiety Disorder

This study has been completed.
Sponsor:
Information provided by:
Inje University
ClinicalTrials.gov Identifier:
NCT00613067
First received: January 29, 2008
Last updated: June 29, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention
Generalized Anxiety Disorder
Drug: escitalopram

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Inje University:

Primary Outcome Measures:
  • Event related potential (ERP) N100 [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - HAMA - HAMD - CGI - Beck Anxiety Inventory(self rating) [ Time Frame: baseline, 2, 4, 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: December 2007
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GAD
35 patients with Generalized Anxiety disorder
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
Other Name: lexapro

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00613067

Locations
Korea, Republic of
Psychiatry department, Inje Univ. Ilsanpaik Hospital
Goyang, Kyunggi, Korea, Republic of, 414-410
Sponsors and Collaborators
Inje University
Investigators
Principal Investigator: Seung-Hwan Lee, MD, PhD Psychiatry department, Inje Univ. Ilsanpaik Hospital
Study Director: Young-Min Park, MD, PhD Psychiatry department, Inje Univ. Ilsanpaik Hospital
Study Director: Sung-Man Bae, PhD Psychiatry department, Inje Univ. Ilsanpaik Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Seung-Hwan Lee, Department of Psychiatry, Inje Univ. Ilsanpaik Hospital
ClinicalTrials.gov Identifier: NCT00613067     History of Changes
Other Study ID Numbers: IB-0709-053
Study First Received: January 29, 2008
Last Updated: June 29, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Inje University:
Generalized anxiety disorder
N100
Central serotonergic activity

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 28, 2014