Efficacy and Safety of Escitalopram in Patients With Generalized Anxiety Disorder

Condition(s) targeted: Generalized Anxiety Disorder

Intervention: Escitalopram (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: H. Lundbeck A/S

Official(s) and/or principal investigator(s):
Email contact via H. Lundbeck A/S, Study Director, Affiliation: LundbeckClinicalTrials@lundbeck.com

Overall contact:
Email contact via H. Lundbeck A/S, Email: LundbeckClinicalTrials@lundbeck.com

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.

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

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

Primary outcome: 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)

Secondary outcome:

Evaluation of proportion of patients who responded to escitalopram during 8 weeks of treatment using the CGI-I definition

To evaluate safety in patients with GAD treated with 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 20mg/day), in accordance with the national Summary of Products Characteristics (SPC).

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Email contact via H. Lundbeck A/S, Email: LundbeckClinicalTrials@lundbeck.com

RU001, Moscow, Russian Federation; Recruiting

Starting date: March 2009
Ending date: January 2010
Last updated: October 7, 2009