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NCT01185340 · ClinicalTrials.gov registry record · Phase 3
A Study in Participants With Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,056
- Enrollment target
NCT01185340: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT01185340 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 1,056 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01185340, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,056 participants
- Enrollment target
Study Summary
The primary objective of this study is to assess whether LY2216684 12 milligrams (mg) or 18 mg flexible dose once daily is superior to placebo once daily in the adjunctive treatment of participants with major depressive disorder (MDD) who are partial responders to their selective serotonin reuptake inhibitor (SSRI) treatment.
Primary Outcome
The Montgomery-Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.
Interventions
- DRUG Placebo
- DRUG LY2216684
- DRUG SSRI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,056 participants |
| Start Date | 2011-03 |
| Est. Completion | 2013-04 |
| Phase | Phase 3 |
What the finished NCT01185340 record still lists
NCT01185340 is an interventional study that assigns participants to a tested intervention. Its 1,056 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01185340 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01185340 about?
NCT01185340 is a clinical study titled "A Study in Participants With Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor". The primary objective of this study is to assess whether LY2216684 12 milligrams (mg) or 18 mg flexible dose once daily is superior to placebo once daily in the adjunctive treatment of participants with major depressive disorder (MDD) who are partial responders to their selective serotonin reuptake ...
What is the current status of trial NCT01185340?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,056 participants. The study started on 2011-03. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01185340?
The interventions under investigation include: Placebo (DRUG), LY2216684 (DRUG), SSRI (DRUG).
Who is sponsoring clinical trial NCT01185340?
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 NCT01185340's enrollment target sits among peer trials
1,056 277th of 2000 higher than 1,724 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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