Escitalopram in Patients With Social Anxiety Disorder

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of escitalopram after 12 weeks of treatment in patients with Social Anxiety Disorder (SAD), to evaluate proportion of patients who respond to escitalopram during the treatment period, and to evaluate safety of escitalopram.

Detailed Description
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The study will be performed in Russia, as an open-label, uncontrolled, one arm trial. The patients will receive escitalopram for 12 weeks. Start and maintenance dosages as well as dose titration will be left to the investigators' decision (5 to 20 mg/day), in accordance with the national Summary of Products Characteristics (SPC).

Official Title
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Efficacy and Safety of Escitalopram in Patients With Social Anxiety Disorder; Open-label, One Arm Postmarketing Study in Russia

Conditions
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Social Anxiety Disorder

Intervention / Treatment
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* Drug: Escitalopram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient suffers from SAD, diagnosed according to ICD-10 (International Classification of Diseases) The patient meets criteria set in the national SPC for escitalopram The patient is, in the opinion of the investigator, otherwise healthy on the basis of a physical examination, medical history and vital signs Exclusion Criteria: The patient has/has had an alcohol or drug abuse-related disorder, as defined in ICD-10 The patient has contraindications to escitalopram The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to escitalopram The patient has a serious illness and/or serious sequelae thereof, including liver or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance The patient is pregnant or breast-feeding The patient, if a woman of childbearing potential, is not using adequate contraception

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Escitalopram<br> | Drug: Escitalopram<br>* Flexible-dosed (5 to 20 mg Oral Tablets Daily)<br>* Other names: Cipralex, Lexapro;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-I) | The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). | baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-S) | The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). | baseline and 12 weeks | 
| Percentage of Patients Who Responded to Escitalopram After 12 Weeks of Treatment Using CGI-I <= 2 | The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). | baseline and 12 weeks | 
| Percentage of Patients Who Achieved Remission After 12 Weeks of Treatment Using CGI-S <= 2 | The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). | baseline and 12 weeks | 
| Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Work | The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. | baseline and 12 weeks | 
| Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Family | The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. | baseline and 12 weeks | 
| Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Social | The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. | baseline and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social Anxiety Disorder, SAD, Antidepressant, Anxiolytic