Depressive Disorder, Major Clinical Trial
Official title:
A Double-Blind, Placebo-Controlled, Multicenter Study of Sirukumab as Adjunctive Treatment to a Monoaminergic Antidepressant in Adults 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 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.
A double-blind, placebo-controlled, multicenter study of sirukumab as adjunctive treatment to a monoaminergic antidepressant in adults with major depressive disorder. Participants will be randomly assigned to receive either placebo or sirukumab 50 milligram (mg) at a ratio of 1:1 at Day 1, 28 and 56. Participants will primarily be assessed for change from baseline in Hamilton Depression Rating Scale (HDRS17) score at Week 12. Safety will be monitored throughout the study. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05915013 -
Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response
|
Phase 1 | |
Completed |
NCT04469322 -
Pharmacogenetic Implementation Trial in Veterans With Treatment Refractory Depression
|
N/A | |
Recruiting |
NCT05415397 -
Treating Immuno-metabolic Depression With Anti-inflammatory Drugs
|
Phase 3 | |
Recruiting |
NCT05988333 -
Psychoeducational Intervention for Families With a Member Affected by Major Depression
|
N/A | |
Completed |
NCT02919501 -
Study of the Efficacy and Safety of Initial Administration of 17 mg Vortioxetine Intravenously With 10 mg/Day Vortioxetine Orally in Patients With Major Depressive Disorder
|
Phase 2 | |
Completed |
NCT00976560 -
Clinical Study to Test a New Drug to Treat Major Depression
|
Phase 2 | |
Recruiting |
NCT05518149 -
A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD)
|
Phase 3 | |
Not yet recruiting |
NCT06303076 -
Tizanidine vs. Zolpidem in Primary Insomnia: A Randomized Trial
|
Phase 4 | |
Not yet recruiting |
NCT05901571 -
Acupuncture and Escitalopram for Treating Major Depression Clinical Study
|
N/A | |
Completed |
NCT02452892 -
Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD)
|
N/A | |
Suspended |
NCT02546024 -
Predictors of Treatment Response in Late-onset Major Depressive Disorder
|
N/A | |
Completed |
NCT01407575 -
Buprenorphine for Treatment Resistant Depression
|
Phase 3 | |
Completed |
NCT01583400 -
Enhanced Collaborative Depression Treatment in Primary Care: The RESPECT-D-E Trial
|
N/A | |
Completed |
NCT01152996 -
Safety and Tolerability of Vortioxetine (LuAA21004) - Open Label Extension Study
|
Phase 3 | |
Enrolling by invitation |
NCT00762866 -
Psychiatric Genotype/Phenotype Project Repository
|
||
Completed |
NCT00366652 -
Study Evaluating the Effects of DVS SR and Duloxetine on the Pharmacokinetics of Desipramine in Healthy Subjects
|
Phase 3 | |
Completed |
NCT00384033 -
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder
|
Phase 3 | |
Completed |
NCT00369343 -
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women
|
Phase 3 | |
Completed |
NCT00149643 -
Effectiveness of Fluoxetine in Young People for the Treatment of Major Depression and Marijuana Dependence
|
Phase 2 | |
Completed |
NCT00316160 -
Sexual Functioning Study With Antidepressants
|
Phase 4 |