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NCT01198795 · ClinicalTrials.gov registry record · Phase 4
Safety Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder
A Phase 4 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 4
- Development phase
- 162
- Enrollment target
NCT01198795: Completed Phase 4 study, sponsored by Forest Laboratories.
NCT01198795 is a Phase 4 study that has completed, run by Forest Laboratories. The registered enrollment target is 162 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01198795, a Phase 4 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 162 participants
- Enrollment target
Study Summary
This study will evaluate the long-term safety and tolerability of escitalopram (Lexapro) in children 7 to 11 years of age with major depressive disorder (MDD).
Primary Outcome
The number of patients who experienced one or more TEAE during the 24-week open-label treatment period or the 2-week down-taper period,
Interventions
- DRUG Escitalopram
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 162 participants |
| Start Date | 2010-09 |
| Est. Completion | 2013-04 |
| Phase | Phase 4 |
What the finished NCT01198795 record still lists
NCT01198795 is an interventional study that assigns participants to a tested intervention. The registered 162 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 1 intervention - of which Escitalopram is the first listed.
NCT01198795 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01198795 about?
NCT01198795 is a clinical study titled "Safety Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder". This study will evaluate the long-term safety and tolerability of escitalopram (Lexapro) in children 7 to 11 years of age with major depressive disorder (MDD).
What is the current status of trial NCT01198795?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 162 participants. The study started on 2010-09. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01198795?
The interventions under investigation include: Escitalopram (DRUG).
Who is sponsoring clinical trial NCT01198795?
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 NCT01198795's enrollment target sits among peer trials
162 503rd of 2000 higher than 1,495 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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