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Trial record 12 of 475 for:    ESCITALOPRAM AND Autonomic Agents

A Study to Evaluate the Impact of Escitalopram on Quality of Life and Social Functionality in Patients With Major Depressive Disorder With Anxiety Symptom

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ClinicalTrials.gov Identifier: NCT01870843
Recruitment Status : Completed
First Posted : June 6, 2013
Results First Posted : July 11, 2016
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
Xian-Janssen Pharmaceutical Ltd.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Depressive Disorder, Major
Intervention Drug: Escitalopram
Enrollment 261
Recruitment Details The study was conducted between 09 April 2014 and 04 May 2015 and recruited participants from 10 study centers in China.
Pre-assignment Details Of the 261 participants enrolled, 241 participants were included in the Full Analysis Set.
Arm/Group Title Escitalopram Oxalate
Hide Arm/Group Description Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
Period Title: Overall Study
Started 261
Completed 208
Not Completed 53
Reason Not Completed
Adverse Event             10
Lost to Follow-up             24
Death             1
Withdrawal by Subject             18
Arm/Group Title Escitalopram Oxalate
Hide Arm/Group Description Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
Overall Number of Baseline Participants 241
Hide Baseline Analysis Population Description
Full Analysis Set (FAS): All randomized participants taking at least one dose of study drug and having at least one visit evaluation in treatment phase were included in the FAS.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 241 participants
39.0  (12.75)
[1]
Measure Description: N= 240
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 241 participants
Female
156
  64.7%
Male
85
  35.3%
1.Primary Outcome
Title Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF) From Baseline up to Day 56
Hide Description Q-LES-Q-SF is a 14-item questionnaire in which each question is rated on a 5-point scale with scores ranging from "1 = very poor" to "5 = very good". The total raw score is calculated by summing up the scores for the 14 items. The raw total score ranges from 14 to 70. The raw total score is transformed into a percentage maximum possible score using the following formula: (raw total score minus minimum score) divided by (maximum possible raw score minus minimum score). The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70. Lower score indicate worsening.
Time Frame Baseline, Day 14, Day 28, Day 42 and Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here "n" (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point.
Arm/Group Title Escitalopram Oxalate
Hide Arm/Group Description:
Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
Overall Number of Participants Analyzed 239
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n=239) 39.3  (14.43)
Change at Day 14 (n=219) 9.6  (15.43)
Change at Day 28 (n=230) 15.1  (18.25)
Change at Day 42 (n=230) 19.0  (19.56)
Change at Day 56 (n=230) 22.5  (20.70)
2.Primary Outcome
Title Change in Sheehan Disability Scale (SDS) From Baseline up to Day 56
Hide Description SDS is a composite of 3 self-rated items designed to measure the extent to which 3 major sectors in the participant's life are impaired by panic, anxiety, phobic, or depressive symptoms. The participant 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 by his or her symptoms on a 10-point visual analog scale. To get a total score add up the 3 individual scores and the total score ranges from "0 = unimpaired" to "30 = highly impaired". Higher scores indicate worsening.
Time Frame Baseline, Day 14, Day 28, Day 42, and Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here "n" (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point.
Arm/Group Title Escitalopram Oxalate
Hide Arm/Group Description:
Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
Overall Number of Participants Analyzed 234
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n=234) 17.4  (5.87)
Change at Day 14 (n=216) -4.6  (5.80)
Change at Day 28 (n=225) -7.0  (6.09)
Change at Day 42 (n=225) -8.3  (6.73)
Change at Day 56 (n=225) -10.1  (6.80)
3.Secondary Outcome
Title Remission Rate Based on Montgomery-Asberg Depression Rating Scale (MADRS) up to Day 56
Hide Description Remission rate is defined as percentage of participants with MADRS total scores less than or equal to 10 at the endpoint (at week 8). The MADRS is a 10-item scale designed to measure depression severity. Each item is scored on 7-point scale, from 0 = not present/normal to 6 = severe/continuous presence of the symptoms and the total score (addition of all 10-items) ranges from "0 to 60". The interpretations of the scores are: 0 to 6= normal/symptom absent; 7 to 19= mild depression; 20 to 34= moderate depression; more than 34= severe depression.
Time Frame Day 7, Day 14, Day 28, Day 42 and Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here "n" (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point.
Arm/Group Title Escitalopram Oxalate
Hide Arm/Group Description:
Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
Overall Number of Participants Analyzed 240
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Day 7 (n=235)
3.4
(1.1 to 5.7)
Day 14 (n=240)
16.3
(11.6 to 20.9)
Day 28 (n=240)
27.5
(21.9 to 33.2)
Day 42 (n=240)
43.3
(37.1 to 49.6)
Day 56 (n=240)
61.7
(55.5 to 67.8)
4.Secondary Outcome
Title Treatment Improvement Rate at the End of Week 1 and Week 2
Hide Description Onset of effect is defined as the reduction rate greater than or equal to 20 percent change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total scores. The MADRS is a 10-item scale designed to measure depression severity. Each item is scored on 7-point scale, from 0 = not present/normal to 6 = severe/continuous presence of the symptoms and the total score (addition of all 10-items) ranges from "0 to 60". The interpretations of the scores are: 0 to 6= normal/symptom absent; 7 to 19= mild depression; 20 to 34= moderate depression; more than 34= severe depression.
Time Frame Week 1 and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here "n" (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point.
Arm/Group Title Escitalopram Oxalate
Hide Arm/Group Description:
Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
Overall Number of Participants Analyzed 240
Measure Type: Number
Unit of Measure: Participants
Week 1 (n=235) 98
Week 2 (n=240) 174
5.Secondary Outcome
Title Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores From Baseline up to Day 56
Hide Description The MADRS is a 10-item scale designed to measure depression severity. Each item is scored on a 7-point scale and the scores range from "0 = item not present/normal" to "6 = severe/continuous presence of the symptoms". Total score is calculated by adding the scores for all the 10 items and it ranges from "0 to 60". The interpretations of the scores are: 0 to 6= normal/symptom absent; 7 to 19= mild depression; 20 to 34= moderate depression; more than 34= severe depression.
Time Frame Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period.
Arm/Group Title Escitalopram Oxalate
Hide Arm/Group Description:
Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
Overall Number of Participants Analyzed 241
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Baseline
29.1
(28.2 to 29.9)
Change at Day 7
-5.6
(-6.4 to -4.9)
Change at Day 14
-10.5
(-11.5 to -9.5)
Change at Day 28
-13.6
(-14.7 to -12.5)
Change at Day 42
-16.4
(-17.6 to -15.3)
Change at Day 56
-19.1
(-20.2 to -17.9)
6.Secondary Outcome
Title Change in Hamilton Anxiety Scale (HAM-A) Total Scores From Baseline up to Day 56
Hide Description HAM-A is a rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe). Total score is calculated by adding the scores for each of the 14 items and the score ranges from "0 to 56". The interpretation of total scores are: 0 to 17 is considered to be mild, 18 to 25 mild to moderate, and 26 to 30 moderate to severe and above 30 indicate very severe anxiety. Higher scores indicate worsening.
Time Frame Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period.
Arm/Group Title Escitalopram Oxalate
Hide Arm/Group Description:
Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
Overall Number of Participants Analyzed 241
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Baseline
25.6
(24.7 to 26.5)
Change at Day 7
-5.6
(-6.4 to -4.8)
Change at Day 14
-10.1
(-11.1 to -9.1)
Change at Day 28
-12.9
(-13.9 to -11.9)
Change at Day 42
-15.1
(-16.2 to -14.0)
Change at Day 56
-17.5
(-18.6 to -16.4)
7.Secondary Outcome
Title Change in Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) Total Scores From Baseline up to Day 56
Hide Description QIDS-SR contains 16 question regarding 9 Major depression disorder symptoms (sleep, weight, psychomotor changes, depressed mood, decreased interest, fatigue, guilt, concentration, and suicidal ideation). Each question is rated on a 4-point scale (range, 0 to 3). Total score is the sum of scores calculated by adding scores for each question and the interpretation is as follows: 0-5 (no depression likely); 6-10 (possibly mildly depressed); 11-15 (moderate depression); 16-20 (severe depression); 21-27 (very severe depression). Higher scores represent more severe depression symptoms.
Time Frame Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period.
Arm/Group Title Escitalopram Oxalate
Hide Arm/Group Description:
Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
Overall Number of Participants Analyzed 241
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Baseline
14.9
(14.3 to 15.4)
Change at Day 7
-2.9
(-3.4 to -2.4)
Change at Day 14
-4.7
(-5.3 to -4.1)
Change at Day 28
-6.1
(-6.8 to -5.4)
Change at Day 42
-7.4
(-8.1 to -6.7)
Change at Day 56
-8.6
(-9.3 to -7.9)
8.Secondary Outcome
Title Depression Response Rate Based on Montgomery-Asberg Depression Rating Scale (MADRS) up to Day 56
Hide Description The MADRS is a 10 item scale designed to measure depression severity. Each item is scored on a 7 point scale and the scores range from "0 = item not present/normal" to "6 = severe/continuous presence of the symptoms". Total score is calculated by adding the scores for all the 10 items and ranges from "0 to 60". The interpretations of the scores are: 0 to 6= normal/symptom absent; 7 to 19= mild depression; 20 to 34= moderate depression; 35 to 60= severe depression data was obtained by Last observation carried forward (LOCF) method.
Time Frame Day 7, Day 14, Day 28, Day 42 and Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here "n" (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point.
Arm/Group Title Escitalopram Oxalate
Hide Arm/Group Description:
Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
Overall Number of Participants Analyzed 240
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Day 7 (n=235)
7.2
(3.9 to 10.6)
Day 14 (n=240)
25.0
(19.5 to 30.5)
Day 28 (n=240)
46.7
(40.4 to 53.0)
Day 42 (n=240)
61.7
(55.5 to 67.8)
Day 56 (n=240)
74.2
(68.6 to 79.7)
9.Secondary Outcome
Title Remission Rate Based on Hamilton Anxiety Scale (HAM-A) up to Day 56
Hide Description HAM-A is a rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5 point scale, ranging from 0 (not present) to 4 (severe). Total score is calculated by adding the scores for each of the 14 items and the score ranges from "0 to 56". The interpretation of total scores are: 0 to 17 is considered to be mild, 18 to 25 mild to moderate, and 26 to 30 moderate to severe and 31 to 56 indicate very severe anxiety. Higher scores indicate worsening data was obtained by Last observation carried forward (LOCF) method.
Time Frame Day 7, Day 14, Day 28, Day 42 and Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here "n" (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point.
Arm/Group Title Escitalopram Oxalate
Hide Arm/Group Description:
Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
Overall Number of Participants Analyzed 240
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Day 7 (n=235)
4.3
(1.7 to 6.8)
Day 14 (n=240)
15.8
(11.2 to 20.5)
Day 28 (n=240)
31.7
(25.8 to 37.6)
Day 42 (n=240)
43.8
(37.5 to 50.0)
Day 56 (n=240)
61.3
(55.1 to 67.4)
10.Secondary Outcome
Title Remission Rate Based on Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) up to Day 56
Hide Description QIDS-SR contains 16 question regarding 9 Major depression disorder symptoms (sleep, weight, psychomotor changes, depressed mood, decreased interest, fatigue, guilt, concentration, and suicidal ideation). Each question is rated on a 4-point scale (range, 0 to 3). Total score is the sum of scores calculated by adding scores for each question and the interpretation is as follows: 0-5 (no depression likely); 6-10 (possibly mildly depressed); 11-15 (moderate depression); 16-20 (severe depression); 21-27 (very severe depression). Higher scores represent more severe depression symptoms data was obtained by Last observation carried forward (LOCF) method.
Time Frame Day 7, Day 14, Day 28, Day 42 and Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here "n" (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point.
Arm/Group Title Escitalopram Oxalate
Hide Arm/Group Description:
Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
Overall Number of Participants Analyzed 237
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Day 7 (n=228)
7.5
(4.1 to 10.9)
Day 14 (n=237)
15.2
(10.6 to 19.8)
Day 28 (n=237)
27.0
(21.4 to 32.7)
Day 42 (n=237)
42.6
(36.3 to 48.9)
Day 56 (n=237)
51.5
(45.1 to 57.8)
Time Frame Baseline up to Day 56
Adverse Event Reporting Description All participants who received at least 1 dose of the study drug were included in the Safety Analysis Set (SS). There were 257 participants included in the SS.
 
Arm/Group Title Escitalopram Oxalate
Hide Arm/Group Description Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
All-Cause Mortality
Escitalopram Oxalate
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Escitalopram Oxalate
Affected / at Risk (%) # Events
Total   4/257 (1.56%)    
Psychiatric disorders   
Suicide attempt * 1  2/257 (0.78%) 
Completed suicide * 1  1/257 (0.39%) 
Surgical and medical procedures   
Hospitalisation * 1  1/257 (0.39%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Escitalopram Oxalate
Affected / at Risk (%) # Events
Total   15/257 (5.84%)    
Gastrointestinal disorders   
Nausea * 1  15/257 (5.84%)  15
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA17.0
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.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Associate TA Manager
Organization: Xian-Janssen Pharmaceutical Ltd
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Xian-Janssen Pharmaceutical Ltd.
ClinicalTrials.gov Identifier: NCT01870843     History of Changes
Other Study ID Numbers: CR100826
ESCITALDEP4005 ( Other Identifier: Xian-Janssen Pharmaceutical Ltd., China )
ESC-C-11-CN-002-V04 ( Other Identifier: Xian-Janssen Pharmaceutical Ltd., China )
First Submitted: June 3, 2013
First Posted: June 6, 2013
Results First Submitted: April 1, 2016
Results First Posted: July 11, 2016
Last Update Posted: July 11, 2016