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Short-term Study of Combination Treatment of Escitalopram and Gaboxadol in Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT00807248
Recruitment Status : Completed
First Posted : December 11, 2008
Results First Posted : August 11, 2011
Last Update Posted : December 17, 2012
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: Escitalopram placebo
Drug: Gaboxadol placebo
Drug: Escitalopram 20 mg
Drug: Gaboxadol 5 mg
Drug: Gaboxadol 10 mg
Enrollment 490
Recruitment Details The patients were recruited from specialist inpatient and outpatient clinics.
Pre-assignment Details  
Arm/Group Title Placebo (Orally, Once Daily) Escitalopram 20 mg and Placebo (Orally, Once Daily) Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily) Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified]
Period Title: Overall Study
Started 71 140 139 140
Completed 50 128 121 126
Not Completed 21 12 18 14
Reason Not Completed
Adverse Event             1             2             2             6
Lack of Efficacy             14             4             8             3
Protocol Violation             0             1             1             0
Withdrawal of Consent             5             5             5             5
Lost to Follow-up             1             0             0             0
Other Reason             0             0             2             0
Arm/Group Title Placebo (Orally, Once Daily) Escitalopram 20 mg and Placebo (Orally, Once Daily) Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily) Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily) Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 71 140 139 140 490
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 71 participants 140 participants 139 participants 140 participants 490 participants
42.6  (11.6) 41.6  (12.6) 42.6  (11.8) 41.5  (10.5) 42.0  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 140 participants 139 participants 140 participants 490 participants
Female
53
  74.6%
96
  68.6%
96
  69.1%
93
  66.4%
338
  69.0%
Male
18
  25.4%
44
  31.4%
43
  30.9%
47
  33.6%
152
  31.0%
Montgomery and Åsberg Depression Rating Scale (MADRS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 71 participants 140 participants 139 participants 140 participants 490 participants
34.7  (4.2) 35.4  (4.3) 35.3  (3.4) 34.7  (3.8) 35.1  (3.9)
[1]
Measure Description: The MADRS is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at 2-point intervals. The total score of the 10 items ranges from 0 to 60.
Hospital Anxiety and Depression Scale (HADS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 71 participants 140 participants 139 participants 140 participants 490 participants
27.5  (5.9) 28.2  (5.3) 28.1  (5.5) 27.4  (5.5) 27.8  (5.5)
[1]
Measure Description: The HADS is a patient-rated scale designed to screen for anxiety and depressive states in medical patients. It consists of two sub-scales: the D-scale measures depression and the A-scale measures anxiety. Each sub-scale contains 7 items, and each item is rated from 0 (absent) to 3 (maximum severity). The score of each sub-scale ranges from 0 to 21, and are analysed separately. The total HADS score ranges from 0 to 42.
Insomnia Severity Index (ISI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 71 participants 140 participants 139 participants 140 participants 490 participants
18.4  (5.0) 18.6  (4.7) 18.2  (4.4) 18.1  (4.8) 18.3  (4.7)
[1]
Measure Description: The ISI is both a brief screening measure of insomnia and an outcomes measure for use in treatment research. It is a brief self-report instrument measuring the patient's perception of his or her insomnia, and it comprises 7 items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28. 0 = no symptoms and 28 = severe symptoms.
Sheehan Disability Scale (SDS): Family Subscale   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 71 participants 140 participants 139 participants 140 participants 490 participants
7.0  (1.4) 7.1  (1.6) 7.2  (1.3) 6.9  (1.4) 7.1  (1.4)
[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.
SDS: Work Subscale   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 71 participants 140 participants 139 participants 140 participants 490 participants
7.3  (1.2) 7.4  (1.3) 7.3  (1.5) 7.0  (1.4) 7.2  (1.4)
[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.
SDS: Social Subscale   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 71 participants 140 participants 139 participants 140 participants 490 participants
7.0  (1.4) 7.1  (1.4) 7.1  (1.5) 6.9  (1.6) 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.
Clinical Global Impression - Severity of Illness (CGI-S)   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 71 participants 140 participants 139 participants 140 participants 490 participants
4.4  (0.9) 4.5  (0.9) 4.3  (0.9) 4.4  (0.9) 4.4  (0.9)
[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).
1.Primary Outcome
Title Montgomery and Åsberg Depression Rating Scale (MADRS)
Hide Description The MADRS is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at 2-point intervals. The total score of the 10 items ranges from 0 to 60.
Time Frame Baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Mean change from baseline to Week 8: Full-analysis Set (FAS), Last Observation Carried Forward (LOCF), Analysis of Covariance (ANCOVA)
Arm/Group Title Placebo (Orally, Once Daily) Escitalopram 20 mg and Placebo (Orally, Once Daily) Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily) Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 71 139 139 140
Mean (Standard Error)
Unit of Measure: Scores on a scale
-13.4  (1.1) -19.0  (0.9) -18.5  (0.9) -19.4  (0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Escitalopram 20 mg and Placebo (Orally, Once Daily), Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6405
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.45
Confidence Interval (2-Sided) 95%
-2.34 to 1.44
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.96
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Escitalopram 20 mg and Placebo (Orally, Once Daily), Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6227
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.47
Confidence Interval (2-Sided) 95%
-1.41 to 2.35
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.96
Estimation Comments [Not Specified]
2.Secondary Outcome
Title MADRS
Hide Description The MADRS is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at 2-point intervals. The total score of the 10 items ranges from 0 to 60.
Time Frame From baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)
Arm/Group Title Placebo (Orally, Once Daily) Escitalopram 20 mg and Placebo (Orally, Once Daily) Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily) Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 71 139 139 140
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-13.4  (1.1) -19.0  (0.9) -18.5  (0.9) -19.4  (0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Orally, Once Daily), Escitalopram 20 mg and Placebo (Orally, Once Daily)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.55
Confidence Interval (2-Sided) 95%
-7.98 to -3.11
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.24
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Orally, Once Daily), Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.09
Confidence Interval (2-Sided) 95%
-7.53 to -2.66
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.24
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (Orally, Once Daily), Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.00
Confidence Interval (2-Sided) 95%
-8.43 to -3.56
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.24
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Hospital Anxiety and Depression Scale (HADS)
Hide Description The HADS is a patient-rated scale designed to screen for anxiety and depressive states in medical patients. It consists of two sub-scales: the D-scale measures depression and the A-scale measures anxiety. Each sub-scale contains 7 items, and each item is rated from 0 (absent) to 3 (maximum severity). The score of each sub-scale ranges from 0 to 21, and are analysed separately. The total HADS score ranges from 0 to 42.
Time Frame Mean change from baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)
Arm/Group Title Placebo (Orally, Once Daily) Escitalopram 20 mg and Placebo (Orally, Once Daily) Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily) Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 71 139 139 140
Mean (Standard Error)
Unit of Measure: Scores on a scale
-9.7  (1.0) -14.7  (0.8) -14.1  (0.8) -15.0  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Orally, Once Daily), Escitalopram 20 mg and Placebo (Orally, Once Daily)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.98
Confidence Interval (2-Sided) 95%
-7.13 to -2.84
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.09
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Orally, Once Daily), Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.46
Confidence Interval (2-Sided) 95%
-6.60 to -2.32
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.09
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (Orally, Once Daily), Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.27
Confidence Interval (2-Sided) 95%
-7.41 to -3.13
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.09
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Insomnia Severity Index (ISI)
Hide Description The ISI is both a brief screening measure of insomnia and an outcomes measure for use in treatment research. It is a brief self-report instrument measuring the patient’s perception of his or her insomnia, and it comprises 7 items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28. 0 = no symptoms and 28 = severe symptoms.
Time Frame Mean change from baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)
Arm/Group Title Placebo (Orally, Once Daily) Escitalopram 20 mg and Placebo (Orally, Once Daily) Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily) Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 71 139 139 140
Mean (Standard Error)
Unit of Measure: Scores on a scale
-6.9  (0.7) -10.0  (0.5) -9.6  (0.5) -10.6  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Orally, Once Daily), Escitalopram 20 mg and Placebo (Orally, Once Daily)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.09
Confidence Interval (2-Sided) 95%
-4.59 to -1.58
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.77
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Orally, Once Daily), Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.64
Confidence Interval (2-Sided) 95%
-4.15 to -1.14
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.77
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (Orally, Once Daily), Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.61
Confidence Interval (2-Sided) 95%
-5.13 to -2.10
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.77
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Sheehan Disability Scale (SDS): Family Subscale
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 Mean change from baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)
Arm/Group Title Placebo (Orally, Once Daily) Escitalopram 20 mg and Placebo (Orally, Once Daily) Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily) Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 71 139 139 140
Mean (Standard Error)
Unit of Measure: Scores on a scale
-2.8  (0.02) -4.0  (0.02) -3.9  (0.02) -4.1  (0.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Orally, Once Daily), Escitalopram 20 mg and Placebo (Orally, Once Daily)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.25
Confidence Interval (2-Sided) 95%
-1.85 to -0.64
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.31
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Orally, Once Daily), Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.11
Confidence Interval (2-Sided) 95%
-1.72 to -0.50
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.31
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (Orally, Once Daily), Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.26
Confidence Interval (2-Sided) 95%
-1.87 to -0.65
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.31
Estimation Comments [Not Specified]
6.Secondary Outcome
Title SDS: Work Subscale
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 Mean change from baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)
Arm/Group Title Placebo (Orally, Once Daily) Escitalopram 20 mg and Placebo (Orally, Once Daily) Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily) Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 71 139 139 140
Mean (Standard Error)
Unit of Measure: Scores on a scale
-2.7  (0.03) -3.8  (0.02) -3.8  (0.02) -4.0  (0.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Orally, Once Daily), Escitalopram 20 mg and Placebo (Orally, Once Daily)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.09
Confidence Interval (2-Sided) 95%
-1.72 to -0.46
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.32
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Orally, Once Daily), Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0013
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.05
Confidence Interval (2-Sided) 95%
-1.69 to -0.41
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.33
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (Orally, Once Daily), Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.29
Confidence Interval (2-Sided) 95%
-1.92 to -0.66
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.32
Estimation Comments [Not Specified]
7.Secondary Outcome
Title SDS: Social Subscale
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 Mean change from baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)
Arm/Group Title Placebo (Orally, Once Daily) Escitalopram 20 mg and Placebo (Orally, Once Daily) Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily) Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 71 139 139 140
Mean (Standard Error)
Unit of Measure: Scores on a scale
-2.7  (0.03) -3.9  (0.02) -3.8  (0.02) -4.1  (0.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Orally, Once Daily), Escitalopram 20 mg and Placebo (Orally, Once Daily)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.20
Confidence Interval (2-Sided) 95%
-1.82 to -0.58
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.31
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Orally, Once Daily), Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.10
Confidence Interval (2-Sided) 95%
-1.72 to -0.48
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.32
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (Orally, Once Daily), Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.38
Confidence Interval (2-Sided) 95%
-2.00 to -0.76
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.32
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Clinical Global Impression - Severity of Illness (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 Mean change from baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)
Arm/Group Title Placebo (Orally, Once Daily) Escitalopram 20 mg and Placebo (Orally, Once Daily) Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily) Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 71 139 139 140
Mean (Standard Error)
Unit of Measure: Scores on a scale
-1.04  (0.13) -1.65  (0.10) -1.58  (0.10) -1.76  (0.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Orally, Once Daily), Escitalopram 20 mg and Placebo (Orally, Once Daily)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.61
Confidence Interval (2-Sided) 95%
-0.89 to -0.34
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Orally, Once Daily), Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.54
Confidence Interval (2-Sided) 95%
-0.82 to -0.26
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (Orally, Once Daily), Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.72
Confidence Interval (2-Sided) 95%
-0.99 to -0.44
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Clinical Global Impression - Global Improvement (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 at Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
At Week 8 (FAS, LOCF, ANCOVA)
Arm/Group Title Placebo (Orally, Once Daily) Escitalopram 20 mg and Placebo (Orally, Once Daily) Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily) Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 71 139 139 140
Mean (Standard Error)
Unit of Measure: Scores on a scale
2.97  (0.12) 2.21  (0.09) 2.35  (0.09) 2.26  (0.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Orally, Once Daily), Escitalopram 20 mg and Placebo (Orally, Once Daily)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.76
Confidence Interval (2-Sided) 95%
-1.02 to -0.50
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Orally, Once Daily), Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.62
Confidence Interval (2-Sided) 95%
-0.88 to -0.36
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (Orally, Once Daily), Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.71
Confidence Interval (2-Sided) 95%
-0.97 to -0.45
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13
Estimation Comments [Not Specified]
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo (Orally, Once Daily) Escitalopram 20 mg and Placebo (Orally, Once Daily) Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily) Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Placebo (Orally, Once Daily) Escitalopram 20 mg and Placebo (Orally, Once Daily) Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily) Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (Orally, Once Daily) Escitalopram 20 mg and Placebo (Orally, Once Daily) Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily) Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/71 (1.41%)   0/140 (0.00%)   0/139 (0.00%)   0/140 (0.00%) 
Infections and infestations         
Appendicitis * 1  1/71 (1.41%)  0/140 (0.00%)  0/139 (0.00%)  0/140 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Placebo (Orally, Once Daily) Escitalopram 20 mg and Placebo (Orally, Once Daily) Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily) Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/71 (16.90%)   22/140 (15.71%)   31/139 (22.30%)   19/140 (13.57%) 
Gastrointestinal disorders         
Diarrhoea * 1  0/71 (0.00%)  2/140 (1.43%)  0/139 (0.00%)  0/140 (0.00%) 
Nausea * 1  0/71 (0.00%)  1/140 (0.71%)  6/139 (4.32%)  2/140 (1.43%) 
Infections and infestations         
Dermatitis allergic * 1  1/71 (1.41%)  0/140 (0.00%)  0/139 (0.00%)  0/140 (0.00%) 
Influenza * 1  1/71 (1.41%)  1/140 (0.71%)  1/139 (0.72%)  2/140 (1.43%) 
Rhinitis allergic * 1  1/71 (1.41%)  0/140 (0.00%)  0/139 (0.00%)  0/140 (0.00%) 
Injury, poisoning and procedural complications         
Accidental overdose * 1  3/71 (4.23%)  4/140 (2.86%)  8/139 (5.76%)  3/140 (2.14%) 
Investigations         
Blood pressure increased * 1  0/71 (0.00%)  2/140 (1.43%)  1/139 (0.72%)  1/140 (0.71%) 
Nervous system disorders         
Headache * 1  4/71 (5.63%)  7/140 (5.00%)  5/139 (3.60%)  3/140 (2.14%) 
Psychomotor hyperactivity * 1  0/71 (0.00%)  0/140 (0.00%)  0/139 (0.00%)  2/140 (1.43%) 
Somnolence * 1  0/71 (0.00%)  0/140 (0.00%)  3/139 (2.16%)  1/140 (0.71%) 
Psychiatric disorders         
Anxiety * 1  0/71 (0.00%)  3/140 (2.14%)  2/139 (1.44%)  3/140 (2.14%) 
Insomnia * 1  3/71 (4.23%)  3/140 (2.14%)  4/139 (2.88%)  2/140 (1.43%) 
Suicidal ideation * 1  0/71 (0.00%)  0/140 (0.00%)  1/139 (0.72%)  2/140 (1.43%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.1
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.
The main publication has to be published before any sub-publications.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: H. Lundbeck A/S
Organization: H. Lundbeck A/S
Phone: +45 3630 1311
EMail: LundbeckClinicalTrials@lundbeck.com
Layout table for additonal information
Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00807248     History of Changes
Other Study ID Numbers: 12213A
2008-000506-36 ( Registry Identifier: EudraCT )
First Submitted: December 10, 2008
First Posted: December 11, 2008
Results First Submitted: June 15, 2011
Results First Posted: August 11, 2011
Last Update Posted: December 17, 2012