Moore

Researchers are comparing two treatments for people with treatment-resistant depression (TRD): intravenous racemic ketamine and intranasal Esketamine (Spravato4). This study is a non-inferiority, multi-site, randomized trial involving about 400 adults over 5 years. It aims to evaluate how well each treatment improves depression symptoms, how acceptable they are to patients, and how well patients tolerate any side effects. The study will also explore factors that might predict which treatment works better for certain individuals. Participants are randomly assigned to receive either ketamine or Esketamine. Ketamine is given as a drip into the arm with a maximum dose of 60 mg per day, infused over 40 minutes, and participants can receive up to 8 doses in their lifetime. Esketamine is administered as a nasal spray at doses between 56 and 84 mg, with options to lower the dose to 28 mg if needed for tolerability. Both treatments follow FDA guidelines and are delivered under clinical supervision. During the study, participants will be monitored for treatment effectiveness, side effects, and overall acceptability over 30 days after treatment. Assessments include self-reported measures of symptom improvement and safety. Participants must be available for the full duration of the study and agree to follow all procedures. Safety measures include blood pressure monitoring and ensuring participants have someone to drive them home after treatment sessions. The total study duration can last up to 5 years with ongoing evaluations.

Researchers are conducting a 5-year observational study across six sites, including academic medical centers and community psychiatric practices, to gather long-term data on patients with Major Depression Disorder who are receiving treatment with either Spravato4 or intravenous (IV) ketamine. The study aims to understand patient satisfaction, usage patterns, long-term effectiveness, and safety of these two treatments for moderate to severe treatment-resistant depression without psychotic features. Participants will either have recently started or are scheduled to start treatment with intranasal esketamine (Spravato4) or IV ketamine as prescribed by their clinician. The study will follow 450 patients in total, tracking their treatment over time without altering their prescribed therapy. Data collection includes baseline measures and ongoing monitoring during clinical treatment. Participants will be involved in regular assessments, including patient satisfaction measured by the TSQM-9 questionnaire over six months. Researchers will monitor treatment adherence, effectiveness, and safety throughout the study period. The study requires participants to be adults willing to comply with study procedures and available for long-term follow-up to provide valuable real-world information.

Researchers are evaluating whether the drug zilebesiran can reduce the risk of major cardiovascular events such as cardiovascular death, nonfatal heart attacks, strokes, or heart failure in adults who have hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This Phase 3 global study is designed to continue until enough cardiovascular events have occurred to assess the treatment's effect. Participants will be randomly assigned to receive either zilebesiran or a placebo, both given as injections under the skin (subcutaneous administration). All participants will continue with their standard care, which includes treatment with at least two antihypertensive medications, one of which must be a diuretic such as a thiazide or loop diuretic. The study is double-blind, so neither participants nor researchers know who is receiving the active drug or placebo. During the study, participants will be closely monitored for cardiovascular events including heart attacks, strokes, heart failure hospitalizations, and cardiovascular deaths over approximately five years. Researchers will collect data on these events to determine the time until the first occurrence of any of these outcomes. Safety assessments and standard clinical evaluations will also be performed throughout the study period to ensure participant well-being.