An Efficacy and Safety Study of Sirukumab in Participants With Major Depressive Disorder
Public ClinicalTrials.gov record NCT02473289. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-Blind, Placebo-Controlled, Multicenter Study of Sirukumab as Adjunctive Treatment to a Monoaminergic Antidepressant in Adults With Major Depressive Disorder
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02473289
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 193 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 21 Years to 64 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 23, 2015 (Actual)
- Primary completion
- May 22, 2018 (Actual)
- Completion
- May 22, 2018 (Actual)
- Last update posted
- Apr 29, 2025
2015 – 2018
United States locations
- U.S. sites
- 24
- U.S. states
- 14
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | — | — |
| Not listed | Little Rock | Arkansas | — | — |
| Not listed | Bellflower | California | — | — |
| Not listed | Glendale | California | — | — |
| Not listed | Lemon Grove | California | — | — |
| Not listed | Orange | California | — | — |
| Not listed | Santa Ana | California | — | — |
| Not listed | Torrance | California | — | — |
| Not listed | Wildomar | California | — | — |
| Not listed | Atlanta | Georgia | — | — |
| Not listed | Decatur | Georgia | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Edgewood | Kentucky | — | — |
| Not listed | Baltimore | Maryland | — | — |
| Not listed | Grand Rapids | Michigan | — | — |
| Not listed | Lebanon | New Hampshire | — | — |
| Not listed | Brooklyn | New York | — | — |
| Not listed | New York | New York | — | — |
| Not listed | Staten Island | New York | — | — |
| Not listed | Columbus | Ohio | — | — |
| Not listed | Oklahoma City | Oklahoma | — | — |
| Not listed | Houston | Texas | — | — |
| Not listed | Plano | Texas | — | — |
| Not listed | Salt Lake City | Utah | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 22 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02473289, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 29, 2025 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02473289 live on ClinicalTrials.gov.