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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01198795
First received: September 9, 2010
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Major Depressive Disorder
Drug: Escitalopram
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Patients With Any Treatment Emergent Adverse Events (TEAEs) [ Time Frame: From Baseline (Week 0) to Week 26 ] [ Designated as safety issue: Yes ]
    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,


Enrollment: 162
Study Start Date: September 2010
Study Completion Date: April 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   7 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01198795

Locations
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
Investigators
Study Chair: Suneeta Ahuja, PhD Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01198795     History of Changes
Other Study ID Numbers: SCT-MD-55
Study First Received: September 9, 2010
Results First Received: January 31, 2014
Last Updated: January 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
depression
major depressive disorder
escitalopram
Lexapro
pediatric

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 18, 2014