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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01198795
• Other study ID #: SCT-MD-55
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2010
• Last updated: January 31, 2014
• Start date: September 2010
• Est. completion date: April 2013

Study information

• Verified date: January 2014
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: April 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 11 Years

Eligibility

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)

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Escitalopram
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.

Locations

Country	Name	City	State
United States	Forest Investigative Site 017	Atlanta	Georgia
United States	Forest Investigative Site 005	Bellevue	Washington
United States	Forest Investigative Site 002	Cleveland	Ohio
United States	Forest Investigative Site 014	Clinton	Utah
United States	Forest Investigative Site 011	Creve Coeur	Missouri
United States	Forest Investigative Site 010	Dallas	Texas
United States	Forest Investigative Site 001	Dothan	Alabama
United States	Forest Investigative Site 013	Jacksonville Beach	Florida
United States	Forest Investigative Site 015	Kirkland	Washington
United States	Forest Investigative Site 012	Oklahoma City	Oklahoma
United States	Forest Investigative Site 007	Omaha	Nebraska
United States	Forest Investigative Site 004	Overland Park	Kansas
United States	Forest Investigative Site 003	Philadelphia	Pennsylvania
United States	Forest Investigative Site 006	San Diego	California
United States	Forest Investigative Site 018	Santa Ana	California
United States	Forest Investigative Site 008	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes