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

Study Overview
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Brief Summary
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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.

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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Escitalopram
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Escitalopram<br>Escitalopram 10mg once daily for three weeks, 10-20mg once daily for up to the remaining 5 weeks | Drug: Escitalopram<br>* Escitalopram 10mg per day for three weeks, 10-20mg per day for up to the remaining 5 weeks<br>* Other names: Lexapro (TM);|
| Placebo Comparator: 2<br>Placebo once daily for up to 8 weeks | Drug: Placebo<br>* Placebo once daily for up to 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score | 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. | Baseline to end of week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impressions - Improvement | 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). | CGI-I score at the end of Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major Depressive Disorder, Depression, Adolescents, Escitalopram, Pediatrics