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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted between 09 April 2014 and 04 May 2015 and recruited participants from 10 study centers in China.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 261 participants enrolled, 241 participants were included in the Full Analysis Set.

Reporting Groups
  Description
Escitalopram Oxalate 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.

Participant Flow:   Overall Study
    Escitalopram Oxalate
STARTED   261 
COMPLETED   208 
NOT COMPLETED   53 
Adverse Event                10 
Lost to Follow-up                24 
Death                1 
Withdrawal by Subject                18 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Escitalopram Oxalate 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.

Baseline Measures
   Escitalopram Oxalate 
Overall Participants Analyzed 
[Units: Participants]
 241 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 39.0  (12.75) 
[1] N= 240
Gender 
[Units: Participants]
 
Female   156 
Male   85 


  Outcome Measures

1.  Primary:   Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF) From Baseline up to Day 56   [ Time Frame: Baseline, Day 14, Day 28, Day 42 and Day 56 ]

2.  Primary:   Change in Sheehan Disability Scale (SDS) From Baseline up to Day 56   [ Time Frame: Baseline, Day 14, Day 28, Day 42, and Day 56 ]

3.  Secondary:   Remission Rate Based on Montgomery-Asberg Depression Rating Scale (MADRS) up to Day 56   [ Time Frame: Day 7, Day 14, Day 28, Day 42 and Day 56 ]

4.  Secondary:   Treatment Improvement Rate at the End of Week 1 and Week 2   [ Time Frame: Week 1 and Week 2 ]

5.  Secondary:   Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores From Baseline up to Day 56   [ Time Frame: Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56 ]

6.  Secondary:   Change in Hamilton Anxiety Scale (HAM-A) Total Scores From Baseline up to Day 56   [ Time Frame: Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56 ]

7.  Secondary:   Change in Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) Total Scores From Baseline up to Day 56   [ Time Frame: Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56 ]

8.  Secondary:   Depression Response Rate Based on Montgomery-Asberg Depression Rating Scale (MADRS) up to Day 56   [ Time Frame: Day 7, Day 14, Day 28, Day 42 and Day 56 ]

9.  Secondary:   Remission Rate Based on Hamilton Anxiety Scale (HAM-A) up to Day 56   [ Time Frame: Day 7, Day 14, Day 28, Day 42 and Day 56 ]

10.  Secondary:   Remission Rate Based on Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) up to Day 56   [ Time Frame: Day 7, Day 14, Day 28, Day 42 and Day 56 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Associate TA Manager
Organization: Xian-Janssen Pharmaceutical Ltd
e-mail: ClinicalTrialDisclosure@its.jnj.com



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