Escitalopram in Patients With Social Anxiety Disorder

NCT00902226 | Completed Phase 4 Results

• 1 other identifier: 12133A
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Anxiety Disorder

Keywords

Social Anxiety Disorder; SAD; Antidepressant; Anxiolytic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (1)

Escitalopram

EXPERIMENTAL

Drug: Escitalopram

Interventions

Escitalopram DRUG

Flexible-dosed (5 to 20 mg Oral Tablets Daily)

Also known as: Cipralex, Lexapro

Escitalopram

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (1)

RU001

Moscow, Russia

Location

MeSH Terms

Conditions

Phobia, Social

Interventions

Escitalopram; Dexetimide

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Study Director
• Organization: H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

email contact via

Study Officials

• Email contact viaH. Lundbeck A/S viaH. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 14, 2009
• First Posted: May 15, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: March 1, 2010
• Last Updated: June 10, 2011
• Results First Posted: June 10, 2011

Record last verified: 2011-05

Locations

RU (1)