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The Safety and Efficacy of Escitalopram in Pediatric Patients With Major Depressive Disorder

Phase 3
Completed
Conditions
Major Depressive Disorder
Interventions
Drug: Placebo
Registration Number
NCT00107120
Lead Sponsor
Forest Laboratories
Brief Summary

Depression affects approximately 2.5% of children and 8% of adolescents. Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults. This study is designed to provide a systematic evaluation of the safety and efficacy of escitalopram in the treatment of depressed pediatric patients, 12 to 17 years of age. Patients completing the study will be eligible to enter an open-label extension study.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
312
Inclusion Criteria
  • Patient must meet Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnostic criteria for Major Depressive Disorder.
  • Patient's current depressive episode must be at least 12 weeks in duration
  • Patient must have a parent or caregiver who must agree to accompany the patient to all clinic visits.
Exclusion Criteria
  • Patients who currently meet DSM-IV criteria for:

    1. attention deficit-hyperactivity disorder
    2. obsessive-compulsive disorder
    3. posttraumatic stress disorder
    4. bipolar disorder
    5. pervasive developmental disorder
    6. mental retardation
    7. conduct disorder
    8. oppositional defiant disorder
  • Patients who are considered a suicide risk (have active suicidal ideation), who have made a suicide attempt, or who have ever been hospitalized because of a suicide attempt.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
EscitalopramEscitalopramEscitalopram 10mg once daily for three weeks, 10-20mg once daily for up to the remaining 5 weeks
2PlaceboPlacebo once daily for up to 8 weeks
Primary Outcome Measures
NameTimeMethod
Change in Children's Depression Rating Scale - Revised (CDRS-R) Total ScoreBaseline to end of week 8

Change from baseline to week 8 in Children's Depression Rating Scale total score. The scale measures 17 depressive symptoms, of which 3 are rated 1-5 and 14 are rated 1-7 (1 = no symptom difficulties; 5 or 7 = severe clinically significant difficulties) for a total score range of 17-113.

Secondary Outcome Measures
NameTimeMethod
Clinical Global Impressions - ImprovementCGI-I score at the end of Week 8

Clinical Global Impressions - Improvement score at the end of week 8. The scale rates improvement or worsening of patient mental health relative to baseline on a scale from 1 (very much improved) to 7 (very much worse).

Trial Locations

Locations (28)

University of California at Davis, MIND Institute, Health Services

🇺🇸

Sacramento, California, United States

UCSD Outpatient Psychiatry Services

🇺🇸

San Diego, California, United States

PCSD - Feighner Research

🇺🇸

San Diego, California, United States

Children's National Medical Center

🇺🇸

Washington, District of Columbia, United States

University of Florida - Child Study Program

🇺🇸

Gainesville, Florida, United States

Clinical Neuroscience Solutions, Inc.

🇺🇸

Jacksonville, Florida, United States

Janus Center for Psychiatric Research

🇺🇸

West Palm Beach, Florida, United States

Kolin Research Group

🇺🇸

Winter Park, Florida, United States

Capstone Clinical Research

🇺🇸

Libertyville, Illinois, United States

Clinco

🇺🇸

Terre Haute, Indiana, United States

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University of California at Davis, MIND Institute, Health Services
🇺🇸Sacramento, California, United States

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