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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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01870843 |
Recruitment Status :
Completed
First Posted : June 6, 2013
Results First Posted : July 11, 2016
Last Update Posted : July 11, 2016
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Sponsor:
Xian-Janssen Pharmaceutical Ltd.
Information provided by (Responsible Party):
Xian-Janssen Pharmaceutical Ltd.
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Study Type | Interventional |
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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 |
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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 | |
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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 | |
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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.
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Age, Continuous
[1] Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 241 participants | |
39.0 (12.75) | ||
[1]
Measure Description: N= 240
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 241 participants | |
Female |
156 64.7%
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Male |
85 35.3%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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 |