Escitalopram in Patients With Social Anxiety Disorder

• ClinicalTrials.gov Identifier: NCT00902226
• Recruitment Status: Completed
• First Posted: May 15, 2009
• Results First Posted: June 10, 2011
• Last Update Posted: June 10, 2011
• Sponsor: H. Lundbeck A/S
• Information provided by: H. Lundbeck A/S

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Social Anxiety Disorder	Drug: Escitalopram	Phase 4

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Escitalopram in Patients With Social Anxiety Disorder; Open-label, One Arm Postmarketing Study in Russia
• Study Start Date: March 2009
• Actual Primary Completion Date: December 2009
• Actual Study Completion Date: March 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: Escitalopram	Drug: Escitalopram; Flexible-dosed (5 to 20 mg Oral Tablets Daily); Other Name: Cipralex, Lexapro

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-S) [ Time Frame: 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).
2. Percentage of Patients Who Responded to Escitalopram After 12 Weeks of Treatment Using CGI-I <= 2 [ 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).
3. Percentage of Patients Who Achieved Remission After 12 Weeks of Treatment Using CGI-S <= 2 [ Time Frame: 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).
4. Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Work [ Time Frame: 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.
5. Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Family [ Time Frame: 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.
6. Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Social [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Russian Federation

RU001

Moscow, Russian Federation

Sponsors and Collaborators

H. Lundbeck A/S

Investigators

• Study Director: Email contact viaH. Lundbeck A/S viaH. Lundbeck A/S; LundbeckClinicalTrials@lundbeck.com

More Information

• Responsible Party: H. Lundbeck A/S
• ClinicalTrials.gov Identifier: NCT00902226 History of Changes
• Other Study ID Numbers: 12133A
• First Posted: May 15, 2009
• Results First Posted: June 10, 2011
• Last Update Posted: June 10, 2011
• Last Verified: May 2011

Keywords provided by H. Lundbeck A/S:

Social Anxiety Disorder; SAD; Antidepressant; Anxiolytic

Additional relevant MeSH terms:

Disease; Anxiety Disorders; Phobia, Social; Pathologic Processes; Mental Disorders; Phobic Disorders; Dexetimide; Citalopram; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Antidepressive Agents, Second-Generation; Antidepressive Agents; Psychotropic Drugs; Antiparkinson Agents; Anti-Dyskinesia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents