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

Forest Laboratories16 sites in 1 country162 target enrollmentSeptember 2010

ConditionsMajor Depressive Disorder

InterventionsEscitalopram

DrugsEscitalopram

Overview

Phase: Phase 4
Intervention: Escitalopram
Conditions: Major Depressive Disorder
Sponsor: Forest Laboratories
Enrollment: 162
Locations: 16
Primary Endpoint: Patients With Any Treatment Emergent Adverse Events (TEAEs)
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

September 2010

End Date

April 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Forest Laboratories

Responsible Party

Sponsor

Eligibility 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)