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Escitalopram in Patients With Generalized Anxiety Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00902564
First Posted: May 15, 2009
Last Update Posted: June 10, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
H. Lundbeck A/S
  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 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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:


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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00902564     History of Changes
Other Study ID Numbers: 12132A
First Submitted: May 14, 2009
First Posted: May 15, 2009
Results First Submitted: March 14, 2011
Results First Posted: June 10, 2011
Last Update Posted: June 10, 2011
Last Verified: May 2011

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

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Pathologic Processes
Mental Disorders
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents