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

Forest Laboratories

Status and phase

Completed

Phase 3

Conditions

Major Depressive Disorder

Treatments

Drug: Placebo

Drug: Escitalopram

Study type

Interventional

Funder types

Industry

Identifiers

NCT00107120

SCT-MD-32

Details and patient eligibility

About

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.

Enrollment

312 patients

Sex

All

Ages

12 to 17 years old

Volunteers

No Healthy Volunteers

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.