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Safety Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01198795
First received: September 9, 2010
Last updated: January 31, 2014
Last verified: January 2014
Results First Received: January 31, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Intervention: Drug: Escitalopram

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patient recruitment occurred at 16 studies sites located in the US from October of 2010 to August of 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All patients completed a 1-week no-drug screening period before beginning treatment with study drug.

Reporting Groups
  Description
Escitalopram Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.

Participant Flow:   Overall Study
    Escitalopram
STARTED   162 
COMPLETED   80 
NOT COMPLETED   82 
Did not meet InclusionExclusion criteria                30 
Withdrawal by Subject                17 
Lost to Follow-up                15 
Adverse Event                9 
Lack of Efficacy                5 
Protocol Violation                2 
Other Reason                4 



  Baseline Characteristics
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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.
A total of 162 unique patients were enrolled in the study. Of these, 118 patients received at least 1 dose of investigational product to comprise the Safety Population. All 118 patients in the Safety Population also had at least 1 postbaseline efficacy assessment, and comprise the Intent To Treat (ITT) Population.

Reporting Groups
  Description
Escitalopram Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.

Baseline Measures
   Escitalopram 
Overall Participants Analyzed 
[Units: Participants]
 118 
Age 
[Units: Years]
Mean (Standard Deviation)
 9.4  (1.2) 
Age, Customized 
[Units: Participants]
 
Ages 7 Years to 8 Years   31 
Ages 9 Years to 10 Years   62 
Age 11 Years   25 
Gender 
[Units: Participants]
 
Female   53 
Male   65 
Race/Ethnicity, Customized 
[Units: Participants]
 
White   85 
Black   26 
Asian   1 
American Indian or Alaska Native   1 
Native Hawaiian or Other Pacific Islander   1 
Other   4 
Race/Ethnicity, Customized 
[Units: Participants]
 
Hispanic or Latino   16 
Not Hispanic or Latino   102 
Region of Enrollment 
[Units: Participants]
 
United States   118 
Weight, mean 
[Units: Kg]
Mean (Standard Deviation)
 42.71  (16.67) 
Height, mean 
[Units: Cm]
Mean (Standard Deviation)
 141.27  (10.22) 
BMI(Body Mass Index), mean 
[Units: Kg/m2]
Mean (Standard Deviation)
 20.86  (5.83) 


  Outcome Measures

1.  Primary:   Patients With Any Treatment Emergent Adverse Events (TEAEs)   [ Time Frame: From Baseline (Week 0) to Week 26 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Carl Gommoll, MS, Sr. Dir. Clinical Development Psychiatry
Organization: Forest Research Institute
phone: 201-427-8000 ext 58124
e-mail: carl.gommoll@frx.com



Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01198795     History of Changes
Other Study ID Numbers: SCT-MD-55
Study First Received: September 9, 2010
Results First Received: January 31, 2014
Last Updated: January 31, 2014
Health Authority: United States: Food and Drug Administration