ERP N1 as a Treatment Predictor of Generalized Anxiety Disorder
| Tracking Information | |||||||||||||
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| First Received Date ICMJE | January 29, 2008 | ||||||||||||
| Last Updated Date | June 29, 2010 | ||||||||||||
| Start Date ICMJE | December 2007 | ||||||||||||
| Primary Completion Date | April 2010 (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 | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| 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 | Not Provided | ||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Not Provided | ||||||||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Generalized Anxiety Disorder | ||||||||||||
| Intervention ICMJE | Drug: escitalopram
Other Name: lexapro |
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| Study Arm (s) | Experimental: GAD
35 patients with Generalized Anxiety disorder
Intervention: Drug: escitalopram |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Estimated Enrollment ICMJE | 35 | ||||||||||||
| Completion Date | May 2010 | ||||||||||||
| Primary Completion Date | April 2010 (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 75 Years | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | Korea, Republic of | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00613067 | ||||||||||||
| Other Study ID Numbers ICMJE | IB-0709-053 | ||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| Responsible Party | Seung-Hwan Lee, Department of Psychiatry, Inje Univ. Ilsanpaik Hospital | ||||||||||||
| Study Sponsor ICMJE | Inje University | ||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | Inje University | ||||||||||||
| Verification Date | June 2010 | ||||||||||||
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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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