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NCT01155661 · ClinicalTrials.gov registry record · Phase 3
A Safety Study in Participants With Major Depressive Disorder
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 608
- Enrollment target
NCT01155661: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT01155661 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 608 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01155661, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 608 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the long-term safety and tolerability of LY2216684 administered once daily (QD) in the adjunctive treatment with a selective serotonin reuptake inhibitor (SSRI) for up to approximately 1 year in participants with major depressive disorder (MDD) who are partial responders to their SSRI treatment.
Primary Outcome
A clinically significant effect was defined as a serious adverse event, regardless of causality. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.
Interventions
- DRUG SSRI
- DRUG LY2216684 (edivoxetine)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 608 participants |
| Start Date | 2010-10 |
| Est. Completion | 2012-12 |
| Phase | Phase 3 |
What the finished NCT01155661 record still lists
NCT01155661 is an interventional study that assigns participants to a tested intervention. The registered 608 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 (21% lower).
The record links to 0 conditions, and to 2 interventions - of which SSRI is the first listed.
NCT01155661 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01155661 about?
NCT01155661 is a clinical study titled "A Safety Study in Participants With Major Depressive Disorder". The primary objective of this study is to evaluate the long-term safety and tolerability of LY2216684 administered once daily (QD) in the adjunctive treatment with a selective serotonin reuptake inhibitor (SSRI) for up to approximately 1 year in participants with major depressive disorder (MDD) who ...
What is the current status of trial NCT01155661?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 608 participants. The study started on 2010-10. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01155661?
The interventions under investigation include: SSRI (DRUG), LY2216684 (edivoxetine) (DRUG).
Who is sponsoring clinical trial NCT01155661?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01155661's enrollment target sits among peer trials
608 603rd of 2000 higher than 1,396 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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