ERP N1 as a Treatment Predictor of GAD
Information source: Inje University
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Generalized Anxiety Disorder
Intervention: escitalopram (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Inje University Official(s) and/or principal investigator(s):
Seung-Hwan Lee, MD, PhD, Principal Investigator, Affiliation: Psychiatry department, Inje Univ. Ilsanpaik Hospital
Young-Min Park, MD, PhD, Study Director, Affiliation: Psychiatry department, Inje Univ. Ilsanpaik Hospital
Sung-Man Bae, PhD, Study Director, Affiliation: Psychiatry department, Inje Univ. Ilsanpaik Hospital
Overall contact:
Jeong In Kim, Master, Phone: 82-31-910-7260, Email: p5p52@hanmail.net
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.
Clinical Details
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 design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: Event related potential (ERP) N100
Secondary outcome: - HAMA
- HAMD
- CGI
- Beck Anxiety Inventory(self rating)
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Jeong In Kim, Master, Phone: 82-31-910-7260, Email: p5p52@hanmail.net
Psychiatry department, Inje Univ. Ilsanpaik Hospital, Goyang, Kyunggi 414-410, Korea, Republic of; Recruiting
Eun-Kyung Choi, BA, Phone: 82-31-910-7260, Email: puritycek@nate.com
Seung-Hwan Lee, MD, PhD, Principal Investigator
Young-Min Park, MD, PhD, Sub-Investigator
Sung-Man Bae, PhD, Sub-Investigator
Additional Information
Starting date: December 2007
Ending date: November 2008
Last updated: January 29, 2008
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