Miami

Researchers are evaluating a study drug called DT-101 in adults diagnosed with Major Depressive Disorder (MDD), a type of depression. This trial aims to compare the effects of DT-101 with a placebo, which looks like the drug but contains no active medicine, to understand if DT-101 can help treat depression. The study is a Phase 2, double-blind, randomized, placebo-controlled trial that also examines the safety and tolerance of DT-101. Participants who are already receiving medication for depression will be randomly assigned to receive either DT-101 or placebo. The treatment period lasts 8 weeks, during which participants will attend the clinic for ongoing assessments. These include physical and neurological exams, blood and urine samples, and questionnaires to monitor health and collect data on depression symptoms. Blood samples will also be analyzed to study how DT-101 is absorbed and processed by the body. Throughout the study, participants will complete general health checks and clinical assessments to ensure ongoing suitability and collect data on symptom changes. The main outcome measured is the change in the Montgomery Åsberg Depression Rating Scale (MADRS) score from the start to day 56. Safety and severity assessments will also be performed. The total participation duration includes screening and 8 weeks of treatment with regular monitoring.

Researchers are evaluating the effect of spironolactone combined with standard care compared to standard care alone in patients with Heart Failure with Preserved Ejection Fraction (HFPEF). This condition is common and serious, but currently lacks effective treatment. The trial is a phase 3 Registry-Randomized Clinical Trial (RRCT) involving patients from the Swedish Heart Failure Registry and the US. HFPEF is defined by heart failure symptoms, elevated NT-proBNP levels, and an ejection fraction of 40% or higher. Participants will be randomly assigned to receive either spironolactone added to their usual care or usual care alone. Spironolactone will be given as 25 mg tablets, starting at 25 mg per day with a possible increase to 50 mg daily if tolerated. If spironolactone is not tolerated, eplerenone may be prescribed instead. The control group will continue with their standard care without spironolactone. The study duration is planned for 9 years, with enrollment lasting 7 years. During the study, researchers will collect data on cardiovascular death and hospitalizations due to heart failure as the primary outcomes. Secondary outcomes include hospitalizations for various causes, adverse events, and treatment adherence. In Sweden, outcomes will be obtained by linking national registries, while in the US, sites and call centers will report outcomes. The trial aims to enroll approximately 2000 patients, with follow-up continuing for at least 5 years after study start to monitor these outcomes.