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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01198795
Recruitment Status : Completed
First Posted : September 10, 2010
Results First Posted : March 14, 2014
Last Update Posted : March 14, 2014
Information provided by (Responsible Party):
Forest Laboratories

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).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Escitalopram Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Long-term Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder
Study Start Date : September 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram
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.
Other Name: Lexapro

Primary Outcome Measures :
  1. Patients With Any Treatment Emergent Adverse Events (TEAEs) [ Time Frame: From Baseline (Week 0) to Week 26 ]
    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,

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01198795

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United States, Alabama
Forest Investigative Site 001
Dothan, Alabama, United States, 36303
United States, California
Forest Investigative Site 006
San Diego, California, United States, 92108
Forest Investigative Site 018
Santa Ana, California, United States, 92701
United States, District of Columbia
Forest Investigative Site 008
Washington, District of Columbia, United States, 20010-2970
United States, Florida
Forest Investigative Site 013
Jacksonville Beach, Florida, United States, 32250
United States, Georgia
Forest Investigative Site 017
Atlanta, Georgia, United States, 30308
United States, Kansas
Forest Investigative Site 004
Overland Park, Kansas, United States, 66211
United States, Missouri
Forest Investigative Site 011
Creve Coeur, Missouri, United States, 63141
United States, Nebraska
Forest Investigative Site 007
Omaha, Nebraska, United States, 68131
United States, Ohio
Forest Investigative Site 002
Cleveland, Ohio, United States, 44106
United States, Oklahoma
Forest Investigative Site 012
Oklahoma City, Oklahoma, United States, 73116
United States, Pennsylvania
Forest Investigative Site 003
Philadelphia, Pennsylvania, United States, 19139
United States, Texas
Forest Investigative Site 010
Dallas, Texas, United States, 75235
United States, Utah
Forest Investigative Site 014
Clinton, Utah, United States, 84015
United States, Washington
Forest Investigative Site 005
Bellevue, Washington, United States, 98007
Forest Investigative Site 015
Kirkland, Washington, United States, 98033
Sponsors and Collaborators
Forest Laboratories
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Study Chair: Suneeta Ahuja, PhD Forest Laboratories
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Responsible Party: Forest Laboratories Identifier: NCT01198795    
Other Study ID Numbers: SCT-MD-55
First Posted: September 10, 2010    Key Record Dates
Results First Posted: March 14, 2014
Last Update Posted: March 14, 2014
Last Verified: January 2014
Keywords provided by Forest Laboratories:
major depressive disorder
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs