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

Sponsored by:	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:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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

Eligibility

Ages Eligible for Study:	18 Years to 65 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 65 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

Contacts

Contact: Jeong In Kim, Master

82-31-910-7260

p5p52@hanmail.net

Locations

Korea, Republic of, Kyunggi
Psychiatry department, Inje Univ. Ilsanpaik Hospital	Recruiting
Goyang, Kyunggi, Korea, Republic of, 414-410
Contact: Eun-Kyung Choi, BA 82-31-910-7260 puritycek@nate.com
Principal Investigator: Seung-Hwan Lee, MD, PhD
Sub-Investigator: Young-Min Park, MD, PhD
Sub-Investigator: Sung-Man Bae, PhD

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:	Department of Psychiatry, Inje Univ. Ilsanpaik Hospital ( Seung-Hwan Lee )
Study ID Numbers:	IB-0709-053
Study First Received:	January 29, 2008
Last Updated:	January 28, 2009
ClinicalTrials.gov Identifier:	NCT00613067 History of Changes
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Inje University:

Generalized anxiety disorder
N100
Central serotonergic activity

Study placed in the following topic categories:

Neurotransmitter Agents
Cholinergic Antagonists
Psychotropic Drugs
Cholinergic Agents
Serotonin Uptake Inhibitors
Citalopram
Serotonin
Muscarinic Antagonists

Lorazepam
Alprazolam
Anxiety Disorders
Mental Disorders
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Dexetimide
Antidepressive Agents

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Pathologic Processes
Mental Disorders
Therapeutic Uses

Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents
Disease
Citalopram
Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Anxiety Disorders
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009