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Escitalopram in Patients With Generalized Anxiety Disorder
This study has been completed.

First Received on May 14, 2009.   Last Updated on May 11, 2011   History of Changes
Sponsor: H. Lundbeck A/S
Information provided by: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00902564
  Purpose

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.


Condition Intervention Phase
Generalized Anxiety Disorder
 Drug: Escitalopram
 Phase IV

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Escitalopram in Patients With Generalized Anxiety Disorder; Open-label, One Arm Postmarketing Study in Russia

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate
U.S. FDA Resources

Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • Effect of Escitalopram After 8 Weeks of Treatment in Patients With GAD Using the Hamilton Anxiety Scale (HAMA) [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    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:
  • Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-I) [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 30
Study Start Date: March 2009
Study Completion Date: March 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Escitalopram Drug: Escitalopram
Flexible-dosed (5 to 20 mg Oral Tablets Daily)
Other Name: Cipralex, Lexapro

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00902564

Locations
Russian Federation
RU001
Moscow, Russian Federation
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

No publications provided

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00902564     History of Changes
Other Study ID Numbers: 12132A
Study First Received: May 14, 2009
Results First Received: March 14, 2011
Last Updated: May 11, 2011
Health Authority: Russia: Ministry of Health and Social Development of the Russian Federation

Keywords provided by H. Lundbeck A/S:
Generalized Anxiety Disorder
GAD
Antidepressant
Anxiolytic

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on February 09, 2012



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