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

• 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: Xian-Janssen Pharmaceutical Ltd.
• Information provided by (Responsible Party): Xian-Janssen Pharmaceutical Ltd.

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Depressive Disorder, Major
• Intervention: Drug: Escitalopram
• Enrollment: 261

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Escitalopram Oxalate
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
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%

Outcome Measures

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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)

Adverse Events

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
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	--/--
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
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

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Associate TA Manager
• Organization: Xian-Janssen Pharmaceutical Ltd
• EMail: ClinicalTrialDisclosure@its.jnj.com

• Responsible Party: Xian-Janssen Pharmaceutical Ltd.
• ClinicalTrials.gov Identifier: NCT01870843
• 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