Escitalopram in Patients With Generalized Anxiety Disorder

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00902564

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

Generalized Anxiety Disorder

Keywords

Generalized Anxiety Disorder, GAD, Antidepressant, Anxiolytic

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).

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 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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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 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.
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.

Countries

Russia

Participant flow

Participants by arm

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

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Withdrawal by Subject	2

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	37.3 years STANDARD_DEVIATION 12
Clinical Global Impression Severity (CGI-S)	4.5 scores on a scale STANDARD_DEVIATION 0.6
Hamilton Anxiety Scale (HAMA)	31.1 scores on a scale STANDARD_DEVIATION 5.3
Sex: Female, Male Female	19 Participants
Sex: Female, Male Male	11 Participants
Sheehan Disability Scale (SDS) Family	6.1 scores on a scale STANDARD_DEVIATION 2
Sheehan Disability Scale (SDS) Social	6.8 scores on a scale STANDARD_DEVIATION 2.5
Sheehan Disability Scale (SDS) Work	6.8 scores on a scale STANDARD_DEVIATION 1.6

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	13 / 30
serious Total, serious adverse events	0 / 30

Outcome results

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.