Safety Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder
Information source: Forest Laboratories
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depressive Disorder
Intervention: Escitalopram (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Forest Laboratories Official(s) and/or principal investigator(s):
Suneeta Ahuja, PhD, Study Chair, Affiliation: Forest Laboratories
Summary
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).
Clinical Details
Official title: An Open-label Long-term Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Patients With Any Treatment Emergent Adverse Events (TEAEs)
Eligibility
Minimum age: 7 Years.
Maximum age: 11 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Locations and Contacts
Forest Investigative Site 001, Dothan, Alabama 36303, United States
Forest Investigative Site 006, San Diego, California 92108, United States
Forest Investigative Site 018, Santa Ana, California 92701, United States
Forest Investigative Site 008, Washington, District of Columbia 20010-2970, United States
Forest Investigative Site 013, Jacksonville Beach, Florida 32250, United States
Forest Investigative Site 017, Atlanta, Georgia 30308, United States
Forest Investigative Site 004, Overland Park, Kansas 66211, United States
Forest Investigative Site 011, Creve Coeur, Missouri 63141, United States
Forest Investigative Site 007, Omaha, Nebraska 68131, United States
Forest Investigative Site 002, Cleveland, Ohio 44106, United States
Forest Investigative Site 012, Oklahoma City, Oklahoma 73116, United States
Forest Investigative Site 003, Philadelphia, Pennsylvania 19139, United States
Forest Investigative Site 010, Dallas, Texas 75235, United States
Forest Investigative Site 014, Clinton, Utah 84015, United States
Forest Investigative Site 005, Bellevue, Washington 98007, United States
Forest Investigative Site 015, Kirkland, Washington 98033, United States
Additional Information
Starting date: September 2010
Last updated: January 31, 2014
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