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

Forest Laboratories

Status and phase

Completed

Phase 4

Conditions

Major Depressive Disorder

Treatments

Drug: Escitalopram

Study type

Interventional

Funder types

Industry

Identifiers

NCT01198795

SCT-MD-55

Details and patient eligibility

About

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).

Enrollment

162 patients

Sex

All

Ages

7 to 11 years old

Volunteers

No Healthy Volunteers

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)