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

Phase 3

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Escitalopram; 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

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-04-05
• Study First Submitted QC: 2005-04-05
• Study First Posted: 2005-04-06
• Primary Completion: 2007-05
• Results First Submitted: 2009-04-21
• Results First Submitted QC: 2009-09-25
• Results First Posted: 2009-11-04
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-04
• Last Update Posted: 2012-04-06

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

Group	Intervention	Description
Escitalopram	Escitalopram	Escitalopram 10mg once daily for three weeks, 10-20mg once daily for up to the remaining 5 weeks
2	Placebo	Placebo once daily for up to 8 weeks

Primary Outcome Measures

Name	Time	Method
Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score	Baseline 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

Name	Time	Method
Clinical Global Impressions - Improvement	CGI-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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