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

Completed · Phase 4

Conditions studied: Major Depressive Disorder

In brief

This study will evaluate the long-term safety and tolerability of escitalopram (Lexapro) in children 7 to 11 years of age with major depressive disorder (MDD).

Key facts

Study ID

NCT01198795

Run by

Forest Laboratories

People needed

162

Starts

2010-09-01

Expected to finish

2013-04-01

Last updated by the study team

2014-03-14

Who can join

Age: 7 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female outpatients 7 to 11 years of age, inclusive
• 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

You may not qualify if…

• Current principal DSM-IV-TR-based diagnosis of an axis I disorder other than MDD that was the primary focus of treatment
• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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