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NCT00107120 · ClinicalTrials.gov registry record · Phase 3
The Safety and Efficacy of Escitalopram in Pediatric Patients With Major Depressive Disorder
A Phase 3 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 312
- Enrollment target
NCT00107120: Completed Phase 3 study, sponsored by Forest Laboratories.
NCT00107120 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 312 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00107120, a Phase 3 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 312 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Escitalopram
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 312 participants |
| Start Date | 2005-03 |
| Phase | Phase 3 |
What the finished NCT00107120 record still lists
NCT00107120 is an interventional study that assigns participants to a tested intervention. The registered 312 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00107120 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00107120 about?
NCT00107120 is a clinical study titled "The Safety and Efficacy 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 eva...
What is the current status of trial NCT00107120?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 312 participants. The study started on 2005-03.
What interventions are being tested in trial NCT00107120?
The interventions under investigation include: Placebo (DRUG), Escitalopram (DRUG).
Who is sponsoring clinical trial NCT00107120?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00107120's enrollment target sits among peer trials
312 1102nd of 2000 higher than 895 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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