Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01299272 · ClinicalTrials.gov registry record · Phase 3
A Study in Prevention of Re-emergence of Depression Symptoms
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,249
- Enrollment target
NCT01299272: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT01299272 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 1,249 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01299272, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,249 participants
- Enrollment target
Study Summary
The primary objective of this study was to assess the maintenance of efficacy of LY2216684 compared with placebo as adjunctive therapy to selective serotonin reuptake inhibitors (SSRIs) as measured by the time-to-symptom reemergence among participants with major depressive disorder (MDD) who met randomization criteria with adjunctive LY2216684 during the stabilization period. This trial consists of two distinct periods: an open-label treatment period, which consists of two parts, 8 weeks acute open-label with movement to 12 weeks open-label stabilization if participants are in remission at end of 8 weeks (open-label for 20 weeks total) followed by a randomized, double-blind, placebo-controlled period for 24 weeks.
Primary Outcome
Participants meeting any of the following criteria were determined as having major depressive disorder symptom re-emergence: 1) a Montgomery-Asberg Depression Rating Scale (MADRS) total score greater ≥14 or a Clinical Global Impressions of Severity (CGI-S) increase of 2 or more points from Week 18 at 2 consecutive visits or 2) discontinuation due to lack of efficacy/worsening of depression/suicidality. Time from randomization to the first visit at which the participant met the reemergence criter
Interventions
- DRUG Placebo
- DRUG LY2216684
- DRUG SSRI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,249 participants |
| Start Date | 2011-05 |
| Est. Completion | 2013-11 |
| Phase | Phase 3 |
What the finished NCT01299272 record still lists
NCT01299272 is an interventional study that assigns participants to a tested intervention. Its 1,249 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 (62% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01299272 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01299272 about?
NCT01299272 is a clinical study titled "A Study in Prevention of Re-emergence of Depression Symptoms". The primary objective of this study was to assess the maintenance of efficacy of LY2216684 compared with placebo as adjunctive therapy to selective serotonin reuptake inhibitors (SSRIs) as measured by the time-to-symptom reemergence among participants with major depressive disorder (MDD) who met ran...
What is the current status of trial NCT01299272?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,249 participants. The study started on 2011-05. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01299272?
The interventions under investigation include: Placebo (DRUG), LY2216684 (DRUG), SSRI (DRUG).
Who is sponsoring clinical trial NCT01299272?
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 NCT01299272's enrollment target sits among peer trials
1,249 210th of 2000 higher than 1,791 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02743858 · 1,250 participants
Lymphedema Surveillance Study
- NCT04670874 · 1,250 participants
Quality of Life in Cutaneous Lymphoma Patients Using the Skindex29
- NCT04807868 · 1,250 participants
AdventHealth Research Institute Non-Alcoholic Fatty Liver Disease Biobank and Registry (AVAIL)
- NCT05995821 · 1,250 participants
Immunobiology Blood and Tissue Collection of Upper Aerodigestive Malignancies
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia