ERP N1 as a Treatment Predictor of Generalized Anxiety Disorder - Full Text View

Sponsor:	Inje University
Information provided by:	Inje University
ClinicalTrials.gov Identifier:	NCT00613067

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:

MedlinePlus related topics: Anxiety

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

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

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:

Related Info This link exits the ClinicalTrials.gov site

Publications:

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.

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
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on February 12, 2012