The Safety and Efficacy of Escitalopram in Pediatric Patients With Major Depressive Disorder - Full Text View

Sponsor:	Forest Laboratories
Information provided by:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00107120

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 III

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:

MedlinePlus related topics: Depression

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

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 ]

Secondary Outcome Measures:

Clinical Global Impressions - Improvement [ Time Frame: CGI-I score at the end of Week 8 ] [ Designated as safety issue: No ]

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

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

No publications provided by Forest Laboratories

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Emslie GJ, Ventura D, Korotzer A, Tourkodimitris S. Escitalopram in the treatment of adolescent depression: a randomized placebo-controlled multisite trial. J Am Acad Child Adolesc Psychiatry. 2009 Jul;48(7):721-9.

Responsible Party:	Anjana Bose, PhD, Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
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:	December 3, 2009
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
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on February 09, 2012