This study wants to evaluate how well each individual dose of esketamine (56 milligrams \[mg\] and 84 mg) works when compared with dummy treatment (placebo) in improving depressive symptoms in participants with treatment resistant depression (individuals with major depressive disorder \[major depression\] who have not responded to at least 2 different antidepressant treatments given at an adequate dose for an adequate duration in the current episode of depression).
Official registry: https://clinicaltrials.gov/study/NCT07716098 · Janssen Research & Development, LLC · enrollment listed as 348
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are Esketamine 56 mg, Esketamine 84 mg, or Placebo. The registry lists allocation as randomized. This study wants to evaluate how well each individual dose of esketamine (56 milligrams \[mg\] and 84 mg) works when compared with dummy treatment (placebo) in improving depressive symptoms in participants with treatment resistant depression (individuals with major depressive disorder \[major depression\] who have not responded to at least 2 different antidepressant treatments given at an adequate dose for an adequate duration in the current episode of depression).
They plan to enroll about 348 people at 39 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression
Interventions: Esketamine 56 mg, Esketamine 84 mg, Placebo
Primary outcome (registry wording): Double-Blind (DB) Treatment Phase: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Day 1 to the End of the 4-Week Double-Blind Treatment Phase
Study Contact
Participate-In-This-Study1@its.jnj.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
+ 24 sites outside the US on the same record
We will investigate the clinical manifestations and molecular genetic defects of heritable urologic malignant disorders. Families with urologic malignancy with known or suspected genetic basis will be enrolled.
NCT00001238 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)
This protocol will evaluate patients with systemic lupus erythematosus (SLE) and their relatives to learn more about how the disease develops and changes over time. It will also study genetic factors that make a person susceptible to SLE.
NCT00001372 · Official ClinicalTrials.gov record · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
This study is designed to explore the genetics and pathophysiology of diseases presenting with intermittent fever, including familial Mediterranean fever, TRAPS, hyper-IgD syndrome, and related diseases. The following individuals may be eligible for this natural history study: 1) patients with known or suspected familial Mediterranean fever, TRAPS, hyper-IgD syndrome or related disorders; 2) relatives of these patients; 3) healthy, normal volunteers 7 years of age or older.
NCT00001373 · Official ClinicalTrials.gov record · National Human Genome Research Institute (NHGRI)
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary