Suchy Las

Researchers are evaluating the long-term safety and tolerability of adjunctive KarXT, a combination of xanomeline and trospium chloride, in adults aged 18 to 65 with schizophrenia who did not have sufficient symptom control with their current antipsychotic medications. This Phase 3, open-label extension study involves participants who previously completed the treatment period of the ARISE study (KAR-012). The goal is to monitor how well patients tolerate KarXT over an extended period while assessing related safety concerns. Participants receive fixed doses of KarXT capsules twice daily, with doses ranging from 50 mg/20 mg up to 125 mg/30 mg. The study lasts for 52 weeks as an outpatient program. This open-label extension allows researchers to observe the effects and safety of KarXT when added to stable antipsychotic treatment under real-world conditions. During the study, researchers closely monitor participants for any treatment-emergent adverse events from the initial dose through a safety follow-up visit at 54 weeks or early termination. Participants will undergo regular assessments, including clinical evaluations and reports from reliable caregivers who assist with study activities. The study ensures participants maintain stable living situations and continue their background antipsychotic medications throughout the study period.

Researchers are evaluating the effectiveness and safety of milsaperidone compared to a placebo when added to standard treatment in adults with Major Depressive Disorder (MDD). This Phase 3 study specifically focuses on patients who have not responded adequately to their current antidepressant therapy. The goal is to understand how milsaperidone might improve depression symptoms as an additional treatment option. Participants will receive either oral milsaperidone or an oral placebo alongside their existing antidepressant medications. The study is conducted in a randomized, double-blind, placebo-controlled, multicenter design, meaning neither participants nor researchers know who receives the actual drug or placebo during the trial. This setup helps ensure objective assessment of milsaperidone's effects. During the 6-week study period, researchers will monitor changes in depression severity using the Montgomery-Asberg Depression Rating Scale (MADRS). Assessments will include evaluating symptom improvements and safety measures to track any side effects. Participants will be followed closely to ensure adherence and to gather comprehensive data on the treatment's impact.

This research aims to evaluate the long-term safety, tolerability, and effectiveness of NMRA-335140 in adults with major depressive disorder (MDD). It involves participants who completed earlier Phase 3 studies of NMRA-335140 for MDD and met specific eligibility and consent requirements. The study provides an opportunity to extend treatment and monitor outcomes over a longer period. Participants will receive NMRA-335140 at a dose of 80 mg taken orally once daily for a 52-week treatment period. This open-label extension allows continued assessment beyond the initial parent studies, focusing on sustained safety and effectiveness of the medication. Throughout the 52 weeks, researchers will monitor participants for treatment emergent adverse events and use validated clinical scales to assess safety and tolerability. The study's total duration for participants is up to 54 weeks, including safety assessments. Data collected will help understand the long-term effects of NMRA-335140 in managing MDD.