Ness Ziona

Researchers are conducting a phase 3, open-label extension study to assess the long-term safety and tolerability of KarXT for treating mania or mania with mixed features in adults with Bipolar-I disorder. The study focuses on evaluating how participants respond to KarXT over an extended period, emphasizing safety measurements such as adverse events and symptom changes. Participants will receive KarXT at specified doses over a treatment period lasting up to 54 weeks. This study includes participants previously involved in related placebo-controlled studies as well as new participants diagnosed with Bipolar-I disorder with manic symptoms. The treatment may be given alongside standard therapeutic doses of lithium, valproate, or lamotrigine as applicable. Throughout the study, participants will undergo regular assessments including monitoring of treatment emergent adverse events, serious adverse events, and psychiatric symptom scales like the Columbia-Suicide Severity Rating Scale, Young Mania Rating Scale, and others. Safety and tolerability will be closely tracked, with evaluations occurring up to week 54. The entire participation may last until the study end date in June 2028, ensuring comprehensive long-term follow-up.

Researchers are evaluating the effects of KarXT for treating manic episodes in adults with Bipolar-I disorder. This Phase 3, randomized, double-blind, placebo-controlled study aims to assess KarXTs ability to reduce mania symptoms during a 3-week inpatient treatment period. The study includes participants experiencing acute manic episodes or mania with mixed features who require hospitalization. Participants will receive either KarXT or a placebo with flexible dosing during the 3-week inpatient treatment. Before treatment, psychotropic medications must be washed out within 14 days. The study also includes screening before treatment and a safety follow-up, with the entire study lasting up to seven weeks. During the study, participants will be closely monitored with assessments including the Young Mania Rating Scale YMRS and Clinical Global Impressions-Bipolar CGI-BP to measure symptom changes. Safety evaluations and follow-up visits are part of the process, with researchers focusing on symptom improvement and safety over the study duration.

Researchers are evaluating the pharmacokinetics, safety, tolerability, and efficacy of a once-a-month, long-acting subcutaneous injection of Cariprazine Depot in adults eligible for oral Cariprazine treatment. This study involves subjects diagnosed with schizophrenia, bipolar I disorder, or major depressive disorder, focusing on those who are clinically stable or antipsychotic-naive, depending on the cohort. The research is conducted as an open-label, multi-center Phase IIIa trial sponsored by Mapi Pharma Ltd. Participants will receive escalating doses of Cariprazine Depot across three cohorts. Cohorts 1 and 2 receive single doses of 22 mg or 44 mg, respectively, while cohort 3 receives three monthly doses of the maximum tolerated dose MTD. Additionally, oral Cariprazine at 3 mgday is administered for three months for comparison. The study is non-randomized and open-label, with no masking, to assess dose effects and treatment responses. During the study, participants will be monitored for adverse events, injection site reactions, and plasma levels of Cariprazine and its metabolites over 22 to 24 weeks. The efficacy in cohort 3 will be evaluated using symptom scores such as the Positive and Negative Symptom Score PANSS and Clinical Global Impression Scale CGI. Safety and tolerability assessments are conducted throughout, with the study duration extending up to 24 weeks per participant.