Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Escitalopram in Patients With Generalized Anxiety Disorder

This study has been completed.
Sponsor:
Information provided by:
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00902564
First received: May 14, 2009
Last updated: May 11, 2011
Last verified: May 2011

May 14, 2009
May 11, 2011
March 2009
December 2009   (final data collection date for primary outcome measure)
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.
Efficacy of escitalopram after 8 weeks of treatment in patients with GAD using Clinical Global Impression (CGI), Sheehan Disability Scale (SDS), and Hamilton Anxiety Scale (HAMA) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00902564 on ClinicalTrials.gov Archive Site
  • 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.
  • Evaluation of proportion of patients who responded to escitalopram during 8 weeks of treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Response is evaluated using the CGI-I definition [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • To evaluate safety in patients with GAD treated with escitalopram [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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

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.

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).

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Generalized Anxiety Disorder
Drug: Escitalopram
Flexible-dosed (5 to 20 mg Oral Tablets Daily)
Other Name: Cipralex, Lexapro
Experimental: Escitalopram
Intervention: Drug: Escitalopram
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
March 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT00902564
12132A
No
H. Lundbeck A/S
H. Lundbeck A/S
Not Provided
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP