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OpenTrials
Completed

NCT Number: NCT00107120

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

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.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • attention deficit-hyperactivity disorder
  • obsessive-compulsive disorder
  • posttraumatic stress disorder
  • bipolar disorder
  • pervasive developmental disorder
  • mental retardation
  • conduct disorder
  • 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.

Treatment and study plan

Escitalopram

Drug

Escitalopram 10mg per day for three weeks, 10-20mg per day for up to the remaining 5 weeks

Other names: Lexapro (TM)

Placebo

Drug

Placebo once daily for up to 8 weeks

Primary outcomes

  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 outcomes

  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).

Other outcomes

  1. Children's Global Assessment Scale

    Time frame: At baseline and end of week 8

    Change from baseline to week 8 in CGAS score which rates the patient's general level of functioning for the past 14 days on a scale of 1 (most impaired) to 100 (healthiest).

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
First posted
Apr 6, 2005
Registry last updated
Apr 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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