Safety Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder
- Registration Number
- NCT01198795
- Lead Sponsor
- Forest Laboratories
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 162
- 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
-
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Escitalopram Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram
- Primary Outcome Measures
Name Time Method Patients With Any Treatment Emergent Adverse Events (TEAEs) From Baseline (Week 0) to Week 26 The number of patients who experienced one or more TEAE during the 24-week open-label treatment period or the 2-week down-taper period,
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
Forest Investigative Site 017
🇺🇸Atlanta, Georgia, United States
Forest Investigative Site 010
🇺🇸Dallas, Texas, United States
Forest Investigative Site 013
🇺🇸Jacksonville Beach, Florida, United States
Forest Investigative Site 015
🇺🇸Kirkland, Washington, United States
Forest Investigative Site 007
🇺🇸Omaha, Nebraska, United States
Forest Investigative Site 001
🇺🇸Dothan, Alabama, United States
Forest Investigative Site 003
🇺🇸Philadelphia, Pennsylvania, United States
Forest Investigative Site 008
🇺🇸Washington, District of Columbia, United States
Forest Investigative Site 012
🇺🇸Oklahoma City, Oklahoma, United States
Forest Investigative Site 018
🇺🇸Santa Ana, California, United States
Forest Investigative Site 006
🇺🇸San Diego, California, United States
Forest Investigative Site 004
🇺🇸Overland Park, Kansas, United States
Forest Investigative Site 011
🇺🇸Creve Coeur, Missouri, United States
Forest Investigative Site 002
🇺🇸Cleveland, Ohio, United States
Forest Investigative Site 014
🇺🇸Clinton, Utah, United States
Forest Investigative Site 005
🇺🇸Bellevue, Washington, United States