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COMPLETEDPHASE3

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

A Double-blind Flexible Dose Study of Escitalopram in Pediatric Patients With Major Depressive Disorder

NCT00107120•Forest Laboratories

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.

Eligibility

Age

12 - 17 years

Sex

ALL

Healthy Volunteers

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.

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 D.C., 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

Key Dates

Start Date

March 1, 2005

Primary Completion Date

May 1, 2007

Last Updated

April 6, 2012

Enrollment

312

ACTUAL participants

Conditions

Major Depressive Disorder

Interventions

Escitalopram

DRUG

Placebo

DRUG

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

NCT07115329

Major Depressive Disorder

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RECRUITINGPHASE3

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

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Major Depressive Disorder (MDD)Depression in Adults+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 6, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk

Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment

University of Iowa Interventional Psychiatry Service Patient Registry

Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D)