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Escitalopram in Patients With Social Anxiety Disorder

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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:
Information provided by:
H. Lundbeck A/S

Tracking Information
First Submitted Date  ICMJE May 14, 2009
First Posted Date  ICMJE May 15, 2009
Results First Submitted Date  ICMJE March 24, 2011
Results First Posted Date  ICMJE June 10, 2011
Last Update Posted Date June 10, 2011
Study Start Date  ICMJE March 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2011)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: May 14, 2009)
Efficacy of escitalopram after 12 weeks of treatment in patients with SAD using Clinical Global Impression (CGI), Sheehan Disability Scale (SDS) [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT00902226 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2011)
  • 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).
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2009)
  • Evaluation of proportion of patients who responded to escitalopram during 12 weeks of treatment [ Time Frame: 12 weeks ]
  • Response is evaluated using the CGI-I definition [ Time Frame: 12 weeks ]
  • To evaluate safety in patients with SAD treated with escitalopram [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Escitalopram in Patients With Social Anxiety Disorder
Official Title  ICMJE Efficacy and Safety of Escitalopram in Patients With Social Anxiety Disorder; Open-label, One Arm Postmarketing Study in Russia
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Social Anxiety Disorder
Intervention  ICMJE Drug: Escitalopram
Flexible-dosed (5 to 20 mg Oral Tablets Daily)
Other Name: Cipralex, Lexapro
Study Arms  ICMJE Experimental: Escitalopram
Intervention: Drug: Escitalopram
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 14, 2009)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00902226
Other Study ID Numbers  ICMJE 12133A
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. Lundbeck A/S
Study Sponsor  ICMJE H. Lundbeck A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Email contact viaH. Lundbeck A/S viaH. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
PRS Account H. Lundbeck A/S
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP