Obihiro

Researchers are evaluating the long-term safety and tolerability of KarXT in treating mania or mania with mixed features in adults with Bipolar-I disorder. This phase 3, open-label extension study aims to better understand how KarXT performs over an extended period in this population. The study includes participants who either completed previous double-blind placebo-controlled studies or are newly diagnosed with Bipolar-I disorder experiencing manic symptoms. Participants receive KarXT at specified doses on certain days, with some also taking therapeutic doses of Lithium, Valproate, or Lamotrigine as part of their treatment. The study does not mention a placebo group during this extension, focusing instead on monitoring the long-term effects of KarXT alone or in combination with these established therapies. During the study, participants are monitored for adverse events up to week 54 to assess safety. Evaluations include psychiatric assessments using scales such as the Young Mania Rating Scale and CGI-BP score at screening and baseline. Researchers will track treatment-emergent adverse events and overall tolerability throughout the study duration, which lasts up to 54 weeks for each participant.

Researchers are investigating the safety and effectiveness of KarXT in treating manic episodes in adults with Bipolar-I Disorder. This Phase 3 study focuses on individuals experiencing acute mania or mania with mixed features who require hospitalization. The study aims to compare KarXT with a placebo to see how well it reduces manic symptoms during a three-week inpatient period. Participants will be randomly assigned to receive either KarXT or a placebo at specified doses during the inpatient treatment phase. The study is double-blind, so neither the participants nor the researchers know who receives which treatment. The total study duration, including screening, treatment, and safety follow-up, will not exceed seven weeks. During the study, participants will be closely monitored through psychiatric evaluations and rating scales, including the Young Mania Rating Scale (YMRS) to measure changes in mania symptoms by week 3. Other assessments include the Clinical Global Impressions-Bipolar scale and safety evaluations. Researchers will track adherence, symptoms, and any side effects throughout the study period.

This trial investigates the efficacy and safety of SEP-363856 (Ulotaront) in adults aged 18 to 65 experiencing acute psychotic episodes related to schizophrenia. It is a Phase 3, randomized, double-blind, placebo-controlled, and multicenter study designed to evaluate treatment effects in participants undergoing symptom relapse or exacerbation within two months before screening. The study focuses on individuals requiring hospitalization for these symptoms and assesses changes in psychosis severity. Participants are randomly assigned to receive either SEP-363856 tablets or placebo tablets during the treatment period. The study design includes parallel groups to compare outcomes between the investigational drug and placebo. Treatment duration and dosing details are consistent with the study protocol but are not specified in this summary. Throughout the study, researchers monitor participants using the Positive And Negative Syndrome Scale (PANSS) to measure changes in symptom severity from baseline to Week 6. Additional assessments include Clinical Global Impression-Severity (CGI-S) scores and safety evaluations. The total study period includes screening, treatment, and follow-up to ensure comprehensive monitoring of efficacy and safety in acutely psychotic individuals with schizophrenia.

Researchers are evaluating the safety and effectiveness of dupilumab in adults aged 18 to 90 years with chronic pruritus of unknown origin (CPUO), a condition causing severe itching without a known cause. This master protocol includes two parallel, double-blind, placebo-controlled Phase 3 studies (Study A and Study B) designed to assess dupilumab's impact on reducing itch severity. Both studies involve participants experiencing severe itch despite prior treatments and exclude those with pruritus caused by other known conditions. Participants first undergo up to a 4-week screening period, followed by a 4-week run-in phase where they receive a non-sedative antihistamine and an emollient. Those with severe itch at baseline are then randomly assigned to receive either subcutaneous dupilumab or a matching placebo for 24 weeks, alongside the antihistamine and emollient. After treatment, a 12-week follow-up phase monitors participants. Study durations for both studies can last up to 44 weeks per participant. During the study, participants are assessed for changes in itch severity using the worst-itch numerical rating scale (WI-NRS) and patient global impression of severity (PGIS). Researchers track the proportion of participants who achieve significant itch reduction by Week 24 in Study A and by Week 12 in Study B. Safety and efficacy are monitored throughout treatment and follow-up, with participant involvement including regular evaluations, questionnaires, and adherence to the assigned treatment regimen.