Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02473289 · ClinicalTrials.gov registry record · Phase 2
An Efficacy and Safety Study of Sirukumab in Participants With Major Depressive Disorder
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 193
- Enrollment target
NCT02473289 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 193 participants.
The verdict
NCT02473289, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 193 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of sirukumab as adjunctive treatment to antidepressant therapy (monoaminergic antidepressant) where sirukumab (administered as a 50 milligram (mg) subcutaneous (SC) injection at Day 1, Day 28 and Day 56 during the 12- week double-blind treatment period) is compared to adjunctive placebo based on the change from baseline to 12-week endpoint in depressive symptoms as measured by the total score on the Hamilton Depression Rating Scale (HDRS), in participants diagnosed with Major Depressive Disorder (MDD) who have had a suboptimal response to the current standard oral antidepressant therapy and have a screening high sensitivity C-Reactive Protein (hsCRP) \>=0.300 milligram per deciliters (mg/dL) (International System of Units (SI) 3.00 mg/L). A cohort of subjects with hsCRP \<0.300 milligram per deciliter will also be enrolled to allow a better understanding of the relationship between CRP and clinical changes.
Interventions
- DRUG Placebo
- DRUG Sirukumab 50 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 193 participants |
| Start Date | 2015-07-23 |
| Est. Completion | 2018-05-22 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02473289
The ClinicalTrials.gov registry entry for NCT02473289 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 193 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02473289 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02473289 about?
NCT02473289 is a clinical study titled "An Efficacy and Safety Study of Sirukumab in Participants With Major Depressive Disorder". The purpose of this study is to evaluate the efficacy of sirukumab as adjunctive treatment to antidepressant therapy (monoaminergic antidepressant) where sirukumab (administered as a 50 milligram (mg) subcutaneous (SC) injection at Day 1, Day 28 and Day 56 during the 12- week double-blind treatment ...
What is the current status of trial NCT02473289?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 193 participants. The study started on 2015-07-23. Estimated completion is 2018-05-22.
What interventions are being tested in trial NCT02473289?
The interventions under investigation include: Placebo (DRUG), Sirukumab 50 mg (DRUG).
Who is sponsoring clinical trial NCT02473289?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
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.