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

January 31, 2014 updated by: Forest Laboratories

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

162

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Dothan, Alabama, United States, 36303
        • Forest Investigative Site 001
    • California
      • San Diego, California, United States, 92108
        • Forest Investigative Site 006
      • Santa Ana, California, United States, 92701
        • Forest Investigative Site 018
    • District of Columbia
      • Washington, District of Columbia, United States, 20010-2970
        • Forest Investigative Site 008
    • Florida
      • Jacksonville Beach, Florida, United States, 32250
        • Forest Investigative Site 013
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Forest Investigative Site 017
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Forest Investigative Site 004
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Forest Investigative Site 011
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Forest Investigative Site 007
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Forest Investigative Site 002
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • Forest Investigative Site 012
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19139
        • Forest Investigative Site 003
    • Texas
      • Dallas, Texas, United States, 75235
        • Forest Investigative Site 010
    • Utah
      • Clinton, Utah, United States, 84015
        • Forest Investigative Site 014
    • Washington
      • Bellevue, Washington, United States, 98007
        • Forest Investigative Site 005
      • Kirkland, Washington, United States, 98033
        • Forest Investigative Site 015

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Lexapro

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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,
From Baseline (Week 0) to Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Investigators

  • Study Chair: Suneeta Ahuja, PhD, Forest Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

September 9, 2010

First Submitted That Met QC Criteria

September 9, 2010

First Posted (Estimate)

September 10, 2010

Study Record Updates

Last Update Posted (Estimate)

March 14, 2014

Last Update Submitted That Met QC Criteria

January 31, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCT-MD-55

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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