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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00107120
Recruitment Status : Completed
First Posted : April 6, 2005
Results First Posted : November 4, 2009
Last Update Posted : April 6, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Escitalopram Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind Flexible Dose Study of Escitalopram in Pediatric Patients With Major Depressive Disorder
Study Start Date : March 2005
Actual Primary Completion Date : May 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Escitalopram
Escitalopram 10mg once daily for three weeks, 10-20mg once daily for up to the remaining 5 weeks
Drug: Escitalopram
Escitalopram 10mg per day for three weeks, 10-20mg per day for up to the remaining 5 weeks
Other Name: Lexapro (TM)

Placebo Comparator: 2
Placebo once daily for up to 8 weeks
Drug: Placebo
Placebo once daily for up to 8 weeks

Primary Outcome Measures :
  1. Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score [ Time Frame: 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 :
  1. Clinical Global Impressions - Improvement [ Time Frame: 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).

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00107120

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Sponsors and Collaborators
Forest Laboratories
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Study Director: Daniel Ventura, PhD Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
Publications of Results:
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Responsible Party: Forest Laboratories Identifier: NCT00107120    
Other Study ID Numbers: SCT-MD-32
First Posted: April 6, 2005    Key Record Dates
Results First Posted: November 4, 2009
Last Update Posted: April 6, 2012
Last Verified: April 2012
Keywords provided by Forest Laboratories:
Major Depressive Disorder
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Pathologic Processes
Behavioral Symptoms
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs