Safety Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder
NCT ID: NCT01198795
Last Updated: 2014-03-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
162 participants
INTERVENTIONAL
2010-09-30
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram
Escitalopram
Patients who meet eligibility criteria will receive open-label escitalopram. 10-20mg oral administration (10mg tablets) once daily for 24-weeks with a 2-week downtaper period.
Interventions
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Escitalopram
Patients who meet eligibility criteria will receive open-label escitalopram. 10-20mg oral administration (10mg tablets) once daily for 24-weeks with a 2-week downtaper period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Current diagnosis of MDD based on DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) criteria as confirmed by K-SADS-PL (Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime) with a minimum duration of 6 weeks
* Patient's parent(s), guardian(s), or LAR(s) is capable of providing information about his or her condition, provides informed consent, and agrees to accompany the patient to all study visits. (Preferably the same parent, guardian, or LAR will accompany the patient to all study visits)
* Patient's family is sufficiently organized and stable to guarantee adequate safety monitoring
Exclusion Criteria
* Patients with a diagnosis of conduct disorder will not be allowed to participate in this study
* Current diagnosis of mental retardation, dementia, or amnestic or other cognitive disorders based on DSM-IV-TR criteria
* History of allergy, intolerance, or hypersensitivity to escitalopram, citalopram, or other drugs of the same class
* Imminent risk of injuring self or others or causing significant damage to property, as judged by the PI
* Suicide risk as determined by meeting any of the following criteria:
* Any suicide attempt
* Significant risk, as judged by the PI, based on the psychiatric interview or information collected in the Columbia-Suicide Severity Rating Scale (C-SSRS)
7 Years
11 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Suneeta Ahuja, PhD
Role: STUDY_CHAIR
Forest Laboratories
Locations
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Forest Investigative Site 001
Dothan, Alabama, United States
Forest Investigative Site 006
San Diego, California, United States
Forest Investigative Site 018
Santa Ana, California, United States
Forest Investigative Site 008
Washington D.C., District of Columbia, United States
Forest Investigative Site 013
Jacksonville Beach, Florida, United States
Forest Investigative Site 017
Atlanta, Georgia, United States
Forest Investigative Site 004
Overland Park, Kansas, United States
Forest Investigative Site 011
Creve Coeur, Missouri, United States
Forest Investigative Site 007
Omaha, Nebraska, United States
Forest Investigative Site 002
Cleveland, Ohio, United States
Forest Investigative Site 012
Oklahoma City, Oklahoma, United States
Forest Investigative Site 003
Philadelphia, Pennsylvania, United States
Forest Investigative Site 010
Dallas, Texas, United States
Forest Investigative Site 014
Clinton, Utah, United States
Forest Investigative Site 005
Bellevue, Washington, United States
Forest Investigative Site 015
Kirkland, Washington, United States
Countries
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Other Identifiers
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SCT-MD-55
Identifier Type: -
Identifier Source: org_study_id
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