Clinical trial NCT01198795: Safety Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder
Official title: An Open-label Long-term Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Keywords: depression
major depressive disorder
escitalopram
Lexapro
pediatric
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2010-09-10
Enrollment: 162
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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)

Primary outcomes:
measure: Patients With Any Treatment Emergent Adverse Events (TEAEs)
timeFrame: From Baseline (Week 0) to Week 26
Secondary outcomes:
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Forest Investigative Site 001
state: Alabama
city: San Diego
country: United States
facility: Forest Investigative Site 006
state: California
city: Santa Ana
country: United States
facility: Forest Investigative Site 018
state: California
city: Washington
country: United States
facility: Forest Investigative Site 008
state: District of Columbia
city: Jacksonville Beach
country: United States
facility: Forest Investigative Site 013
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 017
state: Georgia
city: Overland Park
country: United States
facility: Forest Investigative Site 004
state: Kansas
city: Creve Coeur
country: United States
facility: Forest Investigative Site 011
state: Missouri
city: Omaha
country: United States
facility: Forest Investigative Site 007
state: Nebraska
city: Cleveland
country: United States
facility: Forest Investigative Site 002
state: Ohio
city: Oklahoma City
country: United States
facility: Forest Investigative Site 012
state: Oklahoma
city: Philadelphia
country: United States
facility: Forest Investigative Site 003
state: Pennsylvania
city: Dallas
country: United States
facility: Forest Investigative Site 010
state: Texas
city: Clinton
country: United States
facility: Forest Investigative Site 014
state: Utah
city: Bellevue
country: United States
facility: Forest Investigative Site 005
state: Washington
city: Kirkland
country: United States
facility: Forest Investigative Site 015
state: Washington
Study officials:
affiliation: Forest Laboratories
name: Suneeta Ahuja, PhD
role: STUDY_CHAIR
References: