Escitalopram in Patients With Generalized Anxiety Disorder

Generalized Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00902564
• Other study ID #: 12132A
• Status: Completed
• Phase: Phase 4
• First received: May 14, 2009
• Last updated: May 11, 2011
• Start date: March 2009
• Est. completion date: March 2010

Study information

• Verified date: May 2011
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Drug:
• Escitalopram
Flexible-dosed (5 to 20 mg Oral Tablets Daily)

Locations

Country	Name	City	State
Russian Federation	RU001	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Escitalopram After 8 Weeks of Treatment in Patients With GAD Using the Hamilton Anxiety Scale (HAMA)	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.	baseline and 8 weeks	No
Secondary	Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-I)	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).	baseline and 8 weeks	No
Secondary	Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-S)	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).	baseline and 8 weeks	No
Secondary	Percentage of Patients Who Responded to Escitalopram After 8 Weeks of Treatment Using CGI-I <= 2	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).	baseline and 8 weeks	No
Secondary	Percentage of Patients Who Achieved Remission After 8 Weeks of Treatment Using CGI-S <= 2	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).	baseline and 8 weeks	No
Secondary	Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Work	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.	baseline and 8 weeks	No
Secondary	Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Family	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.	baseline and 8 weeks	No
Secondary	Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Social	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.	baseline and 8 weeks	No
Secondary	Percentage of Patients Who Responded According to >= 50% Improvement From Baseline to Week 8 in HAMA Total Score	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.	baseline and 8 weeks	No