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| Tracking Information | |||||||||||||
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| First Received Date ICMJE | January 29, 2008 | ||||||||||||
| Last Updated Date | August 5, 2009 | ||||||||||||
| Start Date ICMJE | December 2007 | ||||||||||||
| Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Event related potential (ERP) N100 [ Time Frame: Baseline ] [ Designated as safety issue: No ] | ||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT00613067 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
- HAMA - HAMD - CGI - Beck Anxiety Inventory(self rating) [ Time Frame: baseline, 2, 4, 8 weeks ] [ Designated as safety issue: No ] | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | ERP N1 as a Treatment Predictor of Generalized Anxiety Disorder | ||||||||||||
| Official Title ICMJE | The Amplitude Change of the Auditory Evoked N1 Component as a Predictor of Response to Escitalopram Treatment in Patients With Generalized Anxiety Disorder | ||||||||||||
| 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. |
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| Detailed Description | |||||||||||||
| Study Phase | |||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Design ICMJE | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||||||||||
| Condition ICMJE | Generalized Anxiety Disorder | ||||||||||||
| Intervention ICMJE | Drug: escitalopram | ||||||||||||
| Study Arms / Comparison Groups | Experimental: 35 patients with Generalized Anxiety disorder | ||||||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 35 | ||||||||||||
| Estimated Completion Date | September 2009 | ||||||||||||
| Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 18 Years to 65 Years | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Korea, Republic of | ||||||||||||
| Administrative Information | |||||||||||||
| NCT ID ICMJE | NCT00613067 | ||||||||||||
| Responsible Party | Seung-Hwan Lee, Department of Psychiatry, Inje Univ. Ilsanpaik Hospital | ||||||||||||
| Study ID Numbers ICMJE | IB-0709-053 | ||||||||||||
| Study Sponsor ICMJE | Inje University | ||||||||||||
| Collaborators ICMJE | |||||||||||||
| Investigators ICMJE |
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| Information Provided By | Inje University | ||||||||||||
| Verification Date | August 2009 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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