| April 5, 2005 |
| September 25, 2009 |
| March 2005 |
| May 2007 (final data collection date for primary outcome measure) |
| 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 ] |
| Children's Depression Rating Scale - Revised |
| Complete list of historical versions of study NCT00107120 on ClinicalTrials.gov Archive Site |
| Clinical Global Impressions - Improvement [ Time Frame: At end of weeks 1-8 ] [ Designated as safety issue: No ] |
- Clinical Global Impression Scales (Severity and Improvement)
- Children's Global assessment Scale
|
| |
| The Safety and Efficacy of Escitalopram in Pediatric Patients With Major Depressive Disorder |
| A Double-blind Flexible Dose Study of Escitalopram in Pediatric Patients With Major Depressive Disorder |
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. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Major Depressive Disorder |
- Drug: Escitalopram
- Drug: Placebo
|
- Experimental: Escitalopram 10mg once daily for three weeks, 10-20mg once daily for up to the remaining 5 weeks
- Placebo Comparator: Placebo once daily for up to 8 weeks
|
| 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. |
| |
| Completed |
| 312 |
|
| May 2007 (final data collection date for primary outcome measure) |
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:
|
| Both |
| 12 Years to 17 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00107120 |
| Anjana Bose, PhD, Forest Research Institute, a subsidiary of Forest Laboratories, Inc. |
| SCT-MD-32 |
| Forest Laboratories |
|
| Study Director: |
Daniel Ventura, PhD |
Forest Research Institute, a subsidiary of Forest Laboratories, Inc. |
|
|
| Forest Laboratories |
| September 2009 |