Escitalopram in Patients With Social Anxiety Disorder

Lundbeck

Status and phase

Completed

Phase 4

Conditions

Social Anxiety Disorder

Treatments

Drug: Escitalopram

Study type

Interventional

Funder types

Industry

Identifiers

NCT00902226

12133A

Details and patient eligibility

About

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.

Full 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).

Enrollment

30 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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