Trial record 19 of 563 for:
ESCITALOPRAM AND Disorders
Safety Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder
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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: NCT01198795 |
Recruitment Status :
Completed
First Posted : September 10, 2010
Results First Posted : March 14, 2014
Last Update Posted : March 14, 2014
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Sponsor:
Forest Laboratories
Information provided by (Responsible Party):
Forest Laboratories
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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 |
Major Depressive Disorder |
Intervention |
Drug: Escitalopram |
Enrollment | 162 |
Participant Flow
Recruitment Details | Patient recruitment occurred at 16 studies sites located in the US from October of 2010 to August of 2012. |
Pre-assignment Details | All patients completed a 1-week no-drug screening period before beginning treatment with study drug. |
Arm/Group Title | Escitalopram |
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Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period. |
Period Title: Overall Study | |
Started | 162 |
Completed | 80 |
Not Completed | 82 |
Reason Not Completed | |
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
Arm/Group Title | Escitalopram | |
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Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period. | |
Overall Number of Baseline Participants | 118 | |
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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.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 118 participants | |
9.4 (1.2) | ||
Age, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 118 participants |
Ages 7 Years to 8 Years | 31 | |
Ages 9 Years to 10 Years | 62 | |
Age 11 Years | 25 | |
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 118 participants | |
Female |
53 44.9%
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Male |
65 55.1%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 118 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
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 118 participants |
Hispanic or Latino | 16 | |
Not Hispanic or Latino | 102 | |
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 118 participants |
118 | ||
Weight, mean
Mean (Standard Deviation) Unit of measure: Kg |
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Number Analyzed | 118 participants | |
42.71 (16.67) | ||
Height, mean
Mean (Standard Deviation) Unit of measure: Cm |
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Number Analyzed | 118 participants | |
141.27 (10.22) | ||
BMI(Body Mass Index), mean
Mean (Standard Deviation) Unit of measure: Kg/m2 |
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Number Analyzed | 118 participants | |
20.86 (5.83) |
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.
All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study.
Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.
Results Point of Contact
Name/Title: | Carl Gommoll, MS, Sr. Dir. Clinical Development Psychiatry |
Organization: | Forest Research Institute |
Phone: | 201-427-8000 ext 58124 |
EMail: | carl.gommoll@frx.com |
Responsible Party: | Forest Laboratories |
ClinicalTrials.gov Identifier: | NCT01198795 |
Other Study ID Numbers: |
SCT-MD-55 |
First Submitted: | September 9, 2010 |
First Posted: | September 10, 2010 |
Results First Submitted: | January 31, 2014 |
Results First Posted: | March 14, 2014 |
Last Update Posted: | March 14, 2014 |