Articles related to CLINICAL TRIALS

The study enrolled 581 adult outpatients with DSM-5-diagnosed MDD, HDRS-17>=22, and >=32 on the Montgomery-Asberg Depression Rating Scale. Patients were randomly assigned to receive zuranolone 20 mg, 30 mg, or placebo for 14 days, followed by an observation period (days 15-42) and an extended follow-up period (days 43–182). The primary endpoint in HDRS-17 at day 15 was change from baseline (CFB). MOUNTAIN did not meet its primary endpoint, but there were significant rapid improvements in depressive symptoms with zuranolone 30 mg at days 3, 8, and 12, and it was generally well tolerated in patients with MDD.

Event-free survival was significantly longer in patients with resectable stage III or IV melanoma who received pembrolizumab both before and after surgery than in those who received adjuvant pembrolizumab alone. New toxic effects were not discovered.

In this randomized trial, standard treatment of rifampin and isoniazid for 24 weeks plus pyrazinamide and ethambutol for the initial 8 weeks was compared with an initial treatment of bedaquiline–linezolid for 8 weeks, extended treatment for persistent clinical disease, monitoring after treatment, and retreatment for relapse. The shorter approach was determined to be non-inferior.

Patients with stroke due to occlusion of the internal carotid artery or the first segment of the middle cerebral artery were randomized 1:1 to medical therapy vs. endovascular thrombectomy within 24 hours after onset. The trial was stopped early for efficacy, with 20% of patients in the thrombectomy group vs. 7 in the medical therapy group achieving functional independence.

The ideal regimen recommended by the guidelines for those with metastatic hormone-sensitive prostate cancer (mHSPC) is darolutamide, ADT, and docetaxel. The combination of ADT and androgen receptor pathway inhibition, which was the norm at the start of the ARASENS trial, has changed the therapeutic landscape for mHSPC; this analysis offers crucial information for choosing the right course of action for particular patients.

An earlier analysis of this phase 3 trial of neoadjuvant and adjuvant therapy showed that the addition of pembrolizumab to neoadjuvant chemotherapy resulted in a significantly higher percentage of patients with early triple-negative breast cancer having a pathological complete response (defined as no invasive cancer in the breast and negative nodes) at definitive surgery. The trial’s main findings on event-free survival have not been published.