Clinical trial NCT00902564: Escitalopram in Patients With Generalized Anxiety Disorder
Official title: Efficacy and Safety of Escitalopram in Patients With Generalized Anxiety Disorder; Open-label, One Arm Postmarketing Study in Russia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Generalized Anxiety Disorder
Keywords: Generalized Anxiety Disorder
GAD
Antidepressant
Anxiolytic
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2009-05-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Effect of Escitalopram After 8 Weeks of Treatment in Patients With GAD Using the Hamilton Anxiety Scale (HAMA)
timeFrame: baseline and 8 weeks
Secondary outcomes:
measure: Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-I)
timeFrame: baseline and 8 weeks
measure: Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-S)
timeFrame: baseline and 8 weeks
measure: Percentage of Patients Who Responded to Escitalopram After 8 Weeks of Treatment Using CGI-I <= 2
timeFrame: baseline and 8 weeks
measure: Percentage of Patients Who Achieved Remission After 8 Weeks of Treatment Using CGI-S <= 2
timeFrame: baseline and 8 weeks
measure: Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Work
timeFrame: baseline and 8 weeks
measure: Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Family
timeFrame: baseline and 8 weeks
measure: Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Social
timeFrame: baseline and 8 weeks
measure: Percentage of Patients Who Responded According to >= 50% Improvement From Baseline to Week 8 in HAMA Total Score
timeFrame: baseline and 8 weeks
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: RU001
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: