Escitalopram in Patients With Social Anxiety Disorder

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00902226

Enrollment

Registered

2009-05-15

Start date

2009-03-31

Completion date

2010-03-31

Last updated

2011-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Social Anxiety Disorder

Keywords

Social Anxiety Disorder, SAD, Antidepressant, Anxiolytic

Brief summary

The purpose of this study is to evaluate the effect of escitalopram after 12 weeks of treatment in patients with Social Anxiety Disorder (SAD), 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 12 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).

Interventions

DRUGEscitalopram

Flexible-dosed (5 to 20 mg Oral Tablets Daily)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* The patient suffers from SAD, diagnosed according to ICD-10 (International Classification of Diseases) * The patient meets criteria set 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

Design outcomes

Primary

Measure	Time frame	Description
Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-I)	baseline and 12 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).

Secondary

Measure	Time frame	Description
Percentage of Patients Who Responded to Escitalopram After 12 Weeks of Treatment Using CGI-I <= 2	baseline and 12 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 12 Weeks of Treatment Using CGI-S <= 2	baseline and 12 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 12 Weeks Using the Clinical Global Impression (CGI-S)	baseline and 12 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 12 Weeks Using Sheehan Disability Scale (SDS) Family	baseline and 12 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 scales, on which 0 = normal functioning and 10 = severe functional impairment.
Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Social	baseline and 12 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 scales, on which 0 = normal functioning and 10 = severe functional impairment.
Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Work	baseline and 12 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 scales, on which 0 = normal functioning and 10 = severe functional impairment.

Countries

Russia

Participant flow

Participants by arm

Arm	Count
Escitalopram (5 to 20 mg Oral Tablets Daily)	30
Total	30

Baseline characteristics

Characteristic	Escitalopram (5 to 20 mg Oral Tablets Daily)
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	30 Participants
Age Continuous	36.3 years STANDARD_DEVIATION 12.5
CGI Severity Score	4.3 scores on a scale STANDARD_DEVIATION 1
Sex: Female, Male Female	24 Participants
Sex: Female, Male Male	6 Participants
Sheehan Disability Scale (SDS) Family	4.3 scores on a scale STANDARD_DEVIATION 2.1
Sheehan Disability Scale (SDS) Social	7.0 scores on a scale STANDARD_DEVIATION 1.5
Sheehan Disability Scale (SDS) Work	6.9 scores on a scale STANDARD_DEVIATION 1.5

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	16 / 30
serious Total, serious adverse events	0 / 30

Outcome results

Primary

Effect of Escitalopram After 12 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).