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Trial record 42 of 485 for:    ESCITALOPRAM AND Antagonists

Escitalopram in Patients With Social Anxiety Disorder

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ClinicalTrials.gov Identifier: NCT00902226
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 Social 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 30
Not Completed 0
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
36.3  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
24
  80.0%
Male
6
  20.0%
CGI Severity Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 30 participants
4.3  (1.0)
[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
6.9  (1.5)
[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 scales, 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
4.3  (2.1)
[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 scales, 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
7.0  (1.5)
[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 scales, on which 0 = normal functioning and 10 = severe functional impairment.
1.Primary Outcome
Title Effect of Escitalopram After 12 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 12 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 30
Mean (Standard Deviation)
Unit of Measure: scores on a scale
2.1  (0.8)
2.Secondary Outcome
Title Effect of Escitalopram After 12 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 12 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 30
Mean (Standard Deviation)
Unit of Measure: scores on a scale
2.6  (0.9)
3.Secondary Outcome
Title Percentage of Patients Who Responded to Escitalopram After 12 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 12 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 30
Measure Type: Number
Unit of Measure: percentage of patients
80
4.Secondary Outcome
Title Percentage of Patients Who Achieved Remission After 12 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 12 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 30
Measure Type: Number
Unit of Measure: percentage of patients
60
5.Secondary Outcome
Title Effect of Escitalopram After 12 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 scales, on which 0 = normal functioning and 10 = severe functional impairment.
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to data being unavailable, 22 participants were analysed for this outcome, in contrast with 30 participants for the other outcomes.
Arm/Group Title Escitalopram (5 to 20 mg Oral Tablets Daily)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: scores on a scale
3.8  (1.9)
6.Secondary Outcome
Title Effect of Escitalopram After 12 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 scales, on which 0 = normal functioning and 10 = severe functional impairment.
Time Frame baseline and 12 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 30
Mean (Standard Deviation)
Unit of Measure: scores on a scale
2.2  (2.1)
7.Secondary Outcome
Title Effect of Escitalopram After 12 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 scales, on which 0 = normal functioning and 10 = severe functional impairment.
Time Frame baseline and 12 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 30
Mean (Standard Deviation)
Unit of Measure: scores on a scale
3.5  (2.1)
Time Frame [Not Specified]
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   16/30 (53.33%) 
Gastrointestinal disorders   
Diarrhoea * 1  2/30 (6.67%) 
Nausea * 1  3/30 (10.00%) 
Nervous system disorders   
Dizziness * 1  2/30 (6.67%) 
Headache * 1  2/30 (6.67%) 
Muscle spasticity * 1  2/30 (6.67%) 
Psychiatric disorders   
Anxiety * 1  2/30 (6.67%) 
Insomnia * 1  3/30 (10.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.0)
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 / intellectual property rights. The Investigator shall send any manuscript / 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 / 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: NCT00902226     History of Changes
Other Study ID Numbers: 12133A
First Submitted: May 14, 2009
First Posted: May 15, 2009
Results First Submitted: March 24, 2011
Results First Posted: June 10, 2011
Last Update Posted: June 10, 2011