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
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