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NCT01173601 · ClinicalTrials.gov registry record · Phase 3
A Fixed Dose Study of Adjunctive Treatment to Antidepressant Therapy for Adults With Major Depressive Disorder
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,416
- Enrollment target
NCT01173601: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT01173601 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 1,416 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01173601, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,416 participants
- Enrollment target
Study Summary
The primary purpose of this study is to assess whether at least 1 dose of LY2216684 (12 milligrams \[mg\] or 18 mg once daily) is superior to placebo once daily in the adjunctive treatment of participants with major depressive disorder (MDD) who were identified as partial responders to an adequate course of treatment with a selective serotonin reuptake inhibitor (SSRI) during an 8-week, double-blind, acute adjunctive treatment phase.
Primary Outcome
The 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 | 1,416 participants |
| Start Date | 2010-11 |
| Est. Completion | 2013-10 |
| Phase | Phase 3 |
What the finished NCT01173601 record still lists
NCT01173601 is an interventional study that assigns participants to a tested intervention. Its 1,416 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 (83% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01173601 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01173601 about?
NCT01173601 is a clinical study titled "A Fixed Dose Study of Adjunctive Treatment to Antidepressant Therapy for Adults With Major Depressive Disorder". The primary purpose of this study is to assess whether at least 1 dose of LY2216684 (12 milligrams \[mg\] or 18 mg once daily) is superior to placebo once daily in the adjunctive treatment of participants with major depressive disorder (MDD) who were identified as partial responders to an adequate c...
What is the current status of trial NCT01173601?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,416 participants. The study started on 2010-11. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01173601?
The interventions under investigation include: Placebo (DRUG), LY2216684 (DRUG), SSRI (DRUG).
Who is sponsoring clinical trial NCT01173601?
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 NCT01173601's enrollment target sits among peer trials
1,416 169th of 2000 higher than 1,832 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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