NCT00613067

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 12, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

June 30, 2010

Status Verified

June 1, 2010

Enrollment Period

2.3 years

First QC Date

January 29, 2008

Last Update Submit

June 29, 2010

Conditions

Generalized Anxiety Disorder

Keywords

Generalized anxiety disorderN100Central serotonergic activity

Outcome Measures

Primary Outcomes (1)

  • Event related potential (ERP) N100

    Baseline

Secondary Outcomes (1)

  • - HAMA - HAMD - CGI - Beck Anxiety Inventory(self rating)

    baseline, 2, 4, 8 weeks

Study Arms (1)

GAD

EXPERIMENTAL

35 patients with Generalized Anxiety disorder

Drug: escitalopram

Interventions

escitalopramDRUG

* 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

Also known as: lexapro
GAD

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DSM-IV TR for GAD
  • Hamilton Rating Scale for Anxiety (HAMA) \>18
  • to 75 years old

You may not qualify if:

  • Severe medical illness
  • Other psychiatric illness
  • HAMD \> 18
  • High suicidal risk
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatry department, Inje Univ. Ilsanpaik Hospital

Goyang, Kyunggi, 414-410, South Korea

Location

Related Publications (3)

  • Linka T, Muller 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. doi: 10.1055/s-2005-864126.

    PMID: 15902586RESULT

  • Linka T, Sartory G, Bender S, Gastpar M, Muller 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. doi: 10.1016/j.jad.2007.01.018. Epub 2007 Feb 20.

    PMID: 17316822RESULT

  • Linka T, Muller 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. doi: 10.1016/j.neulet.2004.06.038.

    PMID: 15337269RESULT

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Seung-Hwan Lee, MD, PhD

    Psychiatry department, Inje Univ. Ilsanpaik Hospital

    PRINCIPAL INVESTIGATOR

  • Young-Min Park, MD, PhD

    Psychiatry department, Inje Univ. Ilsanpaik Hospital

    STUDY DIRECTOR

  • Sung-Man Bae, PhD

    Psychiatry department, Inje Univ. Ilsanpaik Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 29, 2008

First Posted

February 12, 2008

Study Start

December 1, 2007

Primary Completion

April 1, 2010

Study Completion

May 1, 2010

Last Updated

June 30, 2010

Record last verified: 2010-06

Locations

KR(1)