Official Title: “Efficacy and Safety of Escitalopram in Patients With Generalized Anxiety Disorder; Open-label, One Arm Postmarketing Study in Russia”

The purpose of this study is to evaluate efficacy of escitalopram after 8 weeks of treatment in patients with Generalized Anxiety Disorder (GAD), to evaluate proportion of patients who respond to escitalopram during the treatment period, and to evaluate safety of escitalopram.

Study Type: Interventional

Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2009

The study will be performed in Russia, as an open-label, uncontrolled, one arm trial. The patients will receive escitalopram for 8 weeks. Start and maintenance dosages as well as dose titration will be left to the investigators' decision (5 to 20mg/day), in accordance with the national Summary of Products Characteristics (SPC).

Intervention(s) in this Clinical Trial

• Drug: Escitalopram
  • Flexible-dosed (5 to 20mg/day) per os

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Escitalopram

Primary Measures

• Efficacy of escitalopram after 8 weeks of treatment in patients with GAD using Clinical Global Impression (CGI), Sheehan Disability Scale (SDS), and Hamilton Anxiety Scale (HAMA)
  • Time Frame: 8 weeks
    Safety Issue?: No

Secondary Measures

• Evaluation of proportion of patients who responded to escitalopram during 8 weeks of treatment using the CGI-I definition
  • Time Frame: 8 weeks
    Safety Issue?: No
• To evaluate safety in patients with GAD treated with escitalopram
  • Time Frame: 8 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• The patient suffers from GAD, diagnosed according to ICD-10
• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: H. Lundbeck A/S

Overall Clinical Trial Officials and Contacts

Email contact via H. Lundbeck A/S Study Director LundbeckClinicalTrials@lundbeck.com  

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00902564

Study ID Number: 12132A

ClinicalTrials.gov Identifier: NCT00902564

Health Authority: Russia: Ministry of Health and Social Development of the Russian Federation