Clinical trial NCT00902226: Escitalopram in Patients With Social Anxiety Disorder
Official title: Efficacy and Safety of Escitalopram in Patients With Social Anxiety Disorder; Open-label, One Arm Postmarketing Study in Russia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Social Anxiety Disorder
Keywords: Social Anxiety Disorder
SAD
Antidepressant
Anxiolytic
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2009-05-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-I)
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-S)
timeFrame: baseline and 12 weeks
measure: Percentage of Patients Who Responded to Escitalopram After 12 Weeks of Treatment Using CGI-I <= 2
timeFrame: baseline and 12 weeks
measure: Percentage of Patients Who Achieved Remission After 12 Weeks of Treatment Using CGI-S <= 2
timeFrame: baseline and 12 weeks
measure: Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Work
timeFrame: baseline and 12 weeks
measure: Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Family
timeFrame: baseline and 12 weeks
measure: Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Social
timeFrame: baseline and 12 weeks
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: RU001
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact viaH. Lundbeck A/S viaH. Lundbeck A/S
role: STUDY_DIRECTOR
References: