Articles related to CLINICAL TRIALS

Over a 4-year period, 500 patients were distributed equally between the two regimens. Two-year OS, relapse rates, and non-relapse mortality were similar between the two regiments, indicating that the busulfan regimen is non-inferior to the traditional TBI regimen.

The TRAILBLAZER-ALZ Randomized Clinical Trial According to the findings of post-hoc analysis for patients who received donanemab treatment, baseline amyloid levels were directly related to the extent of amyloid reduction and inversely related to the likelihood of obtaining total amyloid clearance. In patients with complete amyloid clearance and in brain areas discovered later in the pathologic sequence, the donanemab-induced slowing of tau was more severe. To support the aforementioned findings, data from additional trials would be crucial, particularly information on treatment response according to APOE ε4 status.

With two cycles of neoadjuvant immunotherapy, nearly every patient with mismatch repair-deficient (dMMR) colon cancer in the NICHE-2 trial achieved a pathologic response. At a median follow-up of 13.1 months, the disease-free survival (DFS) rate was 100% vs. an expected rate for this patient population of 15%.

In this double-blind randomized clinical trial with 93 participants, the percentage of heavy drinking days during 32 weeks of follow-up was significantly lower in the psilocybin group than in the diphenhydramine group and was accompanied by a decrease in daily alcohol consumption.

Sixty-one unmedicated adults — 75% female, mean age of 45 years — with major depressive disorder, body mass index > 25 kg/m2, and plasma high-sensitivity C-reactive protein (hs-CRP) ≥ 3.0 mg/L were randomly assigned to receive EPA 1 g/d, 2 g/d, or 4 g/d or placebo for 12 weeks. The EPA 4 g/d demonstrated a medium effect versus placebo. This dose may alleviate MDD in overweight individuals with elevated inflammatory markers. Further, decline in hs-CRP may be correlated with clinical response.

Dextromethorphan HBr-buproprion HCl has been FDA approved in extended-release tablet form for MDD. The study supporting the approval showed improved MADRS total score at 6 weeks (15.9 points for Auvelity vs 12.1 points for placebo) and a statistically significant difference in the change from baseline in MADRS total score at weeks 1 and 2 between Auvelity (AXSOME) and placebo. “The approval of Auvelity represents a milestone in depression treatment based on its novel oral NMDA antagonist mechanism, its rapid antidepressant efficacy demonstrated in controlled trials, and a relatively favorable safety profile.” Maurizio Fava, MD, Psychiatrist-In-Chief, Massachusetts General Hospital