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

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ClinicalTrials.gov Identifier: NCT00613067
Recruitment Status : Completed
First Posted : February 12, 2008
Last Update Posted : June 30, 2010
Sponsor:
Information provided by:

Study Description
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
Generalized Anxiety Disorder Drug: escitalopram

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
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
Primary Completion Date : April 2010
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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
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
N100
Central serotonergic activity

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Pathologic Processes
Mental Disorders
Citalopram
Dexetimide
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
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents