Escitalopram in Patients With Social Anxiety Disorder

Phase 4

Completed

Conditions: Social Anxiety Disorder

Interventions: Drug: Escitalopram

Registration Number: NCT00902226

Lead Sponsor: H. Lundbeck A/S

Brief Summary: 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: 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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Escitalopram	Escitalopram	-

Primary Outcome Measures

Name	Time	Method
Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-I)	baseline and 12 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-S)	baseline and 12 weeks	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).
Percentage of Patients Who Responded to Escitalopram After 12 Weeks of Treatment Using CGI-I <= 2	baseline and 12 weeks	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).
Percentage of Patients Who Achieved Remission After 12 Weeks of Treatment Using CGI-S <= 2	baseline and 12 weeks	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).
Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Work	baseline and 12 weeks	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.
Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Family	baseline and 12 weeks	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.
Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Social	baseline and 12 weeks	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.