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...
Date First Received: April 5, 2005
Last Updated: February 13, 2008
Verified by: Forest Laboratories, February 2008
Clinical Trial Phase: Phase 3 | Start Date: March 2005
Overall Status: Completed
Estimated Enrollment: 300
Brief Summary
Official Title: “A Double-Blind Flexible Dose Study of Escitalopram in Pediatric Patients With Major Depressive Disorder”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Escitalopram
Outcome Measures for this Clinical Trial
Primary Measures
- Children's Depression Rating Scale - Revised
Secondary Measures
- Clinical Global Impressions - Improvement
- Children's Global assessment Scale
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 12 Years
Maximum Age for this Clinical Trial: 17 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Forest Laboratories
Additional Information
Information obtained from ClinicalTrials.gov on September 04, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00107120
Study ID Number: SCT-MD-32
ClinicalTrials.gov Identifier: NCT00107120
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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