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Escitalopram in Patients With Generalized Anxiety Disorder

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ClinicalTrials.gov Identifier: NCT00902564
Recruitment Status : Completed
First Posted : May 15, 2009
Results First Posted : June 10, 2011
Last Update Posted : June 10, 2011
Sponsor:
Information provided by:
H. Lundbeck A/S

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Generalized Anxiety Disorder
Intervention Drug: Escitalopram
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Escitalopram (5 to 20 mg Oral Tablets Daily)
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 30
Completed 28
Not Completed 2
Reason Not Completed
Withdrawal by Subject             2
Arm/Group Title Escitalopram (5 to 20 mg Oral Tablets Daily)
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
30
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
37.3  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
19
  63.3%
Male
11
  36.7%
Hamilton Anxiety Scale (HAMA)   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 30 participants
31.1  (5.3)
[1]
Measure Description: 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.
Clinical Global Impression Severity (CGI-S)   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 30 participants
4.5  (0.6)
[1]
Measure Description: 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).
Sheehan Disability Scale (SDS) Work   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 30 participants
6.8  (1.6)
[1]
Measure Description: 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.
Sheehan Disability Scale (SDS) Family   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 30 participants
6.1  (2.0)
[1]
Measure Description: 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.
Sheehan Disability Scale (SDS) Social   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 30 participants
6.8  (2.5)
[1]
Measure Description: 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.
1.Primary Outcome
Title Effect of Escitalopram After 8 Weeks of Treatment in Patients With GAD Using the Hamilton Anxiety Scale (HAMA)
Hide Description 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.
Time Frame baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram (5 to 20 mg Oral Tablets Daily)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: scores on a scale
13.1  (6.2)
2.Secondary Outcome
Title Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-I)
Hide Description 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).
Time Frame baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram (5 to 20 mg Oral Tablets Daily)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: scores on a scale
1.2  (0.4)
3.Secondary Outcome
Title Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-S)
Hide Description 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).
Time Frame baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram (5 to 20 mg Oral Tablets Daily)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: scores on a scale
1.9  (0.7)
4.Secondary Outcome
Title Percentage of Patients Who Responded to Escitalopram After 8 Weeks of Treatment Using CGI-I <= 2
Hide Description 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).
Time Frame baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram (5 to 20 mg Oral Tablets Daily)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: percentage of patients
100
5.Secondary Outcome
Title Percentage of Patients Who Achieved Remission After 8 Weeks of Treatment Using CGI-S <= 2
Hide Description 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).
Time Frame baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram (5 to 20 mg Oral Tablets Daily)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: percentage of patients
85.7
6.Secondary Outcome
Title Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Work
Hide Description 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.
Time Frame baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram (5 to 20 mg Oral Tablets Daily)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 21
Mean (Standard Deviation)
Unit of Measure: scores on a scale
2.0  (2.0)
7.Secondary Outcome
Title Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Family
Hide Description 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.
Time Frame baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram (5 to 20 mg Oral Tablets Daily)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: scores on a scale
1.2  (1.9)
8.Secondary Outcome
Title Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Social
Hide Description 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.
Time Frame baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram (5 to 20 mg Oral Tablets Daily)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: scores on a scale
1.7  (2.4)
9.Secondary Outcome
Title Percentage of Patients Who Responded According to >= 50% Improvement From Baseline to Week 8 in HAMA Total Score
Hide Description 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.
Time Frame baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Observed Cases (OC)
Arm/Group Title Escitalopram (5 to 20 mg Oral Tablets Daily)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: percentage of patients
67.9
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Escitalopram (5 to 20 mg Oral Tablets Daily)
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Escitalopram (5 to 20 mg Oral Tablets Daily)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Escitalopram (5 to 20 mg Oral Tablets Daily)
Affected / at Risk (%)
Total   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Escitalopram (5 to 20 mg Oral Tablets Daily)
Affected / at Risk (%)
Total   13/30 (43.33%) 
Gastrointestinal disorders   
Dry mouth * 1  5/30 (16.67%) 
Nervous system disorders   
Headache * 1  2/30 (6.67%) 
Psychiatric disorders   
Anxiety * 1  2/30 (6.67%) 
Insomnia * 1  2/30 (6.67%) 
Skin and subcutaneous tissue disorders   
Hyperhidrosis * 1  2/30 (6.67%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.1)
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
No results can be made public before appropriate steps by Lundbeck to secure patents and/or intellectual property rights. The Investigator shall send any manuscript and/or public presentation to Lundbeck at least 1 month before submission for publication. If Lundbeck finds matters requiring patents or the like, the Investigator shall delay publication and/or public presentation for an additional 3 months.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: H. Lundbeck A/S
Phone: Email contact via ext Lundbeck
EMail: LundbeckClinicalTrials@lundbeck.com
Layout table for additonal 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