Ness Ziona

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 evaluating the safety and effectiveness of KarXT compared to a placebo for treating adults with Bipolar-I disorder experiencing an acute episode of mania or mania with mixed features. This Phase 3 study involves participants who require hospitalization due to their manic episode and aims to assess symptom improvement over a short-term inpatient period. The study lasts up to seven weeks, including screening, treatment, and safety follow-up. Participants will be randomly assigned to receive either KarXT or a placebo in specified doses during a three-week inpatient treatment period. The study is conducted in a double-blind manner, meaning neither the participants nor the researchers know who receives the active drug or placebo. The focus is on the change in mania symptoms measured by the Young Mania Rating Scale during the three weeks. Throughout the study, participants will be closely monitored with psychiatric evaluations and rating scales, including the Young Mania Rating Scale and Clinical Global Impressions-Bipolar scale. Safety assessments continue during the follow-up period. The total participation time, from screening through treatment and safety monitoring, will not exceed seven weeks.

Researchers are evaluating the pharmacokinetics (PK), safety, tolerability, and efficacy of a new once-a-month long-acting subcutaneous injection called Cariprazine Depot in adults eligible for oral Cariprazine treatment. This phase I/IIa, open-label, multi-center study involves adults aged 18 to 64 years diagnosed with schizophrenia, bipolar I disorder, or major depressive disorder. The study aims to assess how the drug and its active metabolites behave in the body, its safety profile, and effectiveness, especially in the third cohort.