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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00107120
First received: April 5, 2005
Last updated: April 4, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Major Depressive Disorder
Drug: Escitalopram
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind Flexible Dose Study of Escitalopram in Pediatric Patients With Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score [ Time Frame: Baseline to end of week 8 ] [ Designated as safety issue: No ]
    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:
  • Clinical Global Impressions - Improvement [ Time Frame: CGI-I score at the end of Week 8 ] [ Designated as safety issue: No ]
    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).


Enrollment: 312
Study Start Date: March 2005
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00107120

  Show 28 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Daniel Ventura, PhD Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
  More Information

Publications:
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00107120     History of Changes
Other Study ID Numbers: SCT-MD-32
Study First Received: April 5, 2005
Results First Received: April 21, 2009
Last Updated: April 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
Major Depressive Disorder
Depression
Adolescents
Escitalopram
Pediatrics

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 27, 2014