Escitalopram in Patients With Generalized Anxiety Disorder

Phase 4

Completed

Conditions: Generalized Anxiety Disorder

Interventions: Drug: Escitalopram

Registration Number: NCT00902564

Lead Sponsor: H. Lundbeck A/S

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Escitalopram	Escitalopram	-

Primary Outcome Measures

Name	Time	Method
Effect of Escitalopram After 8 Weeks of Treatment in Patients With GAD Using the Hamilton Anxiety Scale (HAMA)	baseline and 8 weeks	The HAMA is a 14-item rating scale designed to assess global anxiety symptoms. Each symptom is rated from 0 (absent) to 4 (severe). The total score of the 14 items ranges from 0 to 56.

Secondary Outcome Measures

Name	Time	Method
Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-I)	baseline and 8 weeks	The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-S)	baseline and 8 weeks	The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).
Percentage of Patients Who Responded to Escitalopram After 8 Weeks of Treatment Using CGI-I <= 2	baseline and 8 weeks	The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Percentage of Patients Who Achieved Remission After 8 Weeks of Treatment Using CGI-S <= 2	baseline and 8 weeks	The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).
Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Work	baseline and 8 weeks	The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scale, on which 0 = normal functioning and 10 = severe functional impairment.
Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Family	baseline and 8 weeks	The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scale, on which 0 = normal functioning and 10 = severe functional impairment.
Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Social	baseline and 8 weeks	The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scale, on which 0 = normal functioning and 10 = severe functional impairment.
Percentage of Patients Who Responded According to >= 50% Improvement From Baseline to Week 8 in HAMA Total Score	baseline and 8 weeks	The HAMA is a 14-item rating scale designed to assess global anxiety symptoms. Each symptom is rated from 0 (absent) to 4 (severe). The total score of the 14 items ranges from 0 to 56.