COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu
Trial record 15 of 553 for:    ESCITALOPRAM AND Disorders

ERP N1 as a Treatment Predictor of Generalized Anxiety Disorder (N1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00613067
Recruitment Status : Completed
First Posted : February 12, 2008
Last Update Posted : June 30, 2010
Information provided by:
Inje University

Brief Summary:

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 or disease Intervention/treatment Phase
Generalized Anxiety Disorder Drug: escitalopram Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2007
Actual Primary Completion Date : April 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Event related potential (ERP) N100 [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. - HAMA - HAMD - CGI - Beck Anxiety Inventory(self rating) [ Time Frame: baseline, 2, 4, 8 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00613067

Layout table for location information
Korea, Republic of
Psychiatry department, Inje Univ. Ilsanpaik Hospital
Goyang, Kyunggi, Korea, Republic of, 414-410
Sponsors and Collaborators
Inje University
Layout table for investigator information
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
Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Seung-Hwan Lee, Department of Psychiatry, Inje Univ. Ilsanpaik Hospital Identifier: NCT00613067    
Other Study ID Numbers: IB-0709-053
First Posted: February 12, 2008    Key Record Dates
Last Update Posted: June 30, 2010
Last Verified: June 2010
Keywords provided by Inje University:
Generalized anxiety disorder
Central serotonergic activity
Additional relevant MeSH terms:
Layout table for MeSH terms
Anxiety Disorders
Mental Disorders
Pathologic Processes
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs