Escitalopram in Patients With Social Anxiety Disorder

This study has been completed.
Sponsor:
Information provided by:
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00902226
First received: May 14, 2009
Last updated: May 11, 2011
Last verified: May 2011
  Purpose

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 Intervention Phase
Social Anxiety Disorder
Drug: Escitalopram
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-I) [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    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:
  • Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-S) [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    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).

  • Percentage of Patients Who Responded to Escitalopram After 12 Weeks of Treatment Using CGI-I <= 2 [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    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).

  • Percentage of Patients Who Achieved Remission After 12 Weeks of Treatment Using CGI-S <= 2 [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    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).

  • Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Work [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Family [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Social [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 30
Study Start Date: March 2009
Study Completion Date: March 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Escitalopram Drug: Escitalopram
Flexible-dosed (5 to 20 mg Oral Tablets Daily)
Other Name: Cipralex, Lexapro

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00902226

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

No publications provided

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00902226     History of Changes
Other Study ID Numbers: 12133A
Study First Received: May 14, 2009
Results First Received: March 24, 2011
Last Updated: May 11, 2011
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by H. Lundbeck A/S:
Social Anxiety Disorder
SAD
Antidepressant
Anxiolytic

Additional relevant MeSH terms:
Anxiety Disorders
Phobic Disorders
Mental Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 11, 2014