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

Study Overview
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Brief Summary
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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).

Official Title
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An Open-label Long-term Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Escitalopram


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram | Drug: Escitalopram<br>* 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.<br>* Other names: Lexapro;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients With Any Treatment Emergent Adverse Events (TEAEs) | 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, | From Baseline (Week 0) to Week 26 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, major depressive disorder, escitalopram, Lexapro, pediatric