Phase 4
Completed N=162
Safety Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder
Source: ClinicalTrials.gov NCT01198795 ↗Enrolled (actual)
162
Serious AEs
1.7%
Results posted
Mar 2014
Primary outcomePrimary: Patients With Any Treatment Emergent Adverse Events (TEAEs) — 89 participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patients With Any Treatment Emergent Adverse Events (TEAEs) |
89 | — |
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)
Data sourced from ClinicalTrials.gov (NCT01198795). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.