Escitalopram in Patients With Generalized Anxiety Disorder

NCT ID: NCT00902564

Last Updated: 2011-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-03-31

Brief Summary

The purpose of this study is to evaluate the effect 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.

Detailed Description

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 20 mg/day), in accordance with the national Summary of Products Characteristics (SPC).

Conditions

Generalized Anxiety Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Escitalopram

Group Type: EXPERIMENTAL

Escitalopram

Intervention Type: DRUG

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

Interventions

Escitalopram

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

Intervention Type: DRUG

Other Intervention Names

Cipralex, Lexapro

Eligibility Criteria

Inclusion Criteria

• The patient suffers from GAD, diagnosed according to ICD-10 (International Classification of Diseases)
• The patient meets criteria as set out 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

H. Lundbeck A/S

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@lundbeck.com

Locations

RU001

Moscow, , Russia

Countries

Russia

Other Identifiers

12132A

Identifier Type: -

Identifier Source: org_study_id