Efficacy and Safety of Escitalopram in Patients With Social Anxiety Disorder; Open-label, One Arm Postmarketing Study in Russia
Overview
- Phase
- Phase 4
- Intervention
- Escitalopram
- Conditions
- Social Anxiety Disorder
- Sponsor
- H. Lundbeck A/S
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-I)
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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).
Investigators
Eligibility Criteria
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
Arms & Interventions
Escitalopram
Intervention: Escitalopram
Outcomes
Primary Outcomes
Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-I)
Time Frame: 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 Outcomes
- Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-S)(baseline and 12 weeks)
- Percentage of Patients Who Responded to Escitalopram After 12 Weeks of Treatment Using CGI-I <= 2(baseline and 12 weeks)
- Percentage of Patients Who Achieved Remission After 12 Weeks of Treatment Using CGI-S <= 2(baseline and 12 weeks)
- Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Work(baseline and 12 weeks)
- Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Family(baseline and 12 weeks)
- Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Social(baseline and 12 weeks)