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Escitalopram in Patients With Generalized Anxiety Disorder

Information source: H. Lundbeck A/S
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Generalized Anxiety Disorder

Intervention: Escitalopram (Drug)

Phase: Phase 4

Status: Completed

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

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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Effect of Escitalopram After 8 Weeks of Treatment in Patients With GAD Using the Hamilton Anxiety Scale (HAMA)

Secondary outcome:

Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-I)

Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-S)

Percentage of Patients Who Responded to Escitalopram After 8 Weeks of Treatment Using CGI-I <= 2

Percentage of Patients Who Achieved Remission After 8 Weeks of Treatment Using CGI-S <= 2

Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Work

Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Family

Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Social

Percentage of Patients Who Responded According to >= 50% Improvement From Baseline to Week 8 in HAMA Total Score

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).

Eligibility

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

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

Locations and Contacts

RU001, Moscow, Russian Federation
Additional Information

Starting date: March 2009
Last updated: May 11, 2011

Page last updated: August 23, 2015

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