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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 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 1,249 participants.

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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.

Interventions

  • DRUG Placebo
  • DRUG LY2216684
  • DRUG SSRI

Trial Details

FieldValue
Enrollment Target 1,249 participants
Start Date 2011-05
Est. Completion 2013-11
Phase Phase 3

Sponsor

Eli Lilly and Company

1,341 total trials

What the Registry Record Tells You About NCT01299272

The ClinicalTrials.gov registry entry for NCT01299272 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,249 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT01299272 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.