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

• Clinical Global Impression Scales (Severity and Improvement)
• Children's Global assessment Scale

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.

• Drug: Escitalopram
  Escitalopram 10mg per day for three weeks, 10-20mg per day for up to the remaining 5 weeks
  Other Name: Lexapro (TM)
• Drug: Placebo
  Placebo once daily for up to 8 weeks

• Experimental: Escitalopram
  Escitalopram 10mg once daily for three weeks, 10-20mg once daily for up to the remaining 5 weeks
  Intervention: Drug: Escitalopram
• Placebo Comparator: 2
  Placebo once daily for up to 8 weeks
  Intervention: Drug: Placebo

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.