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

NCT01198795 | Completed Phase 4 Results

• 1 other identifier: SCT-MD-55
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 16

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).

Conditions

Major Depressive Disorder

Keywords

depression; major depressive disorder; escitalopram; Lexapro; pediatric

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

1

EXPERIMENTAL

Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram

Drug: Escitalopram

Interventions

Escitalopram DRUG

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.

Also known as: Lexapro

1

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (16)

Forest Investigative Site 001

Dothan, Alabama, 36303, United States

Location

Forest Investigative Site 006

San Diego, California, 92108, United States

Location

Forest Investigative Site 018

Santa Ana, California, 92701, United States

Location

Forest Investigative Site 008

Washington D.C., District of Columbia, 20010-2970, United States

Location

Forest Investigative Site 013

Jacksonville Beach, Florida, 32250, United States

Location

Forest Investigative Site 017

Atlanta, Georgia, 30308, United States

Location

Forest Investigative Site 004

Overland Park, Kansas, 66211, United States

Location

Forest Investigative Site 011

Creve Coeur, Missouri, 63141, United States

Location

Forest Investigative Site 007

Omaha, Nebraska, 68131, United States

Location

Forest Investigative Site 002

Cleveland, Ohio, 44106, United States

Location

Forest Investigative Site 012

Oklahoma City, Oklahoma, 73116, United States

Location

Forest Investigative Site 003

Philadelphia, Pennsylvania, 19139, United States

Location

Forest Investigative Site 010

Dallas, Texas, 75235, United States

Location

Forest Investigative Site 014

Clinton, Utah, 84015, United States

Location

Forest Investigative Site 005

Bellevue, Washington, 98007, United States

Location

Forest Investigative Site 015

Kirkland, Washington, 98033, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Carl Gommoll, MS, Sr. Dir. Clinical Development Psychiatry
• Organization: Forest Research Institute

carl.gommoll@frx.com

201-427-8000

Study Officials

• Suneeta Ahuja, PhD

  Forest Laboratories

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 10, 2010
• Study Start: September 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: April 1, 2013
• Last Updated: March 14, 2014
• Results First Posted: March 14, 2014

Record last verified: 2014-01

Locations

US (16)