Targovishte

Researchers are evaluating the safety and effectiveness of adding KarXT (Xanomeline/Trospium Chloride) to standard treatment for mania in adults with Bipolar-I Disorder. This Phase 3, randomized, double-blind study focuses on individuals experiencing acute manic episodes, with or without mixed features, who are already taking lithium, valproate, or lamotrigine. The study aims to measure changes in mania symptoms using the Young Mania Rating Scale at Week 5. Participants will be randomly assigned to receive either KarXT or a placebo alongside their stable dose of lithium, valproate, or lamotrigine. The doses of these medications are specified and given on set days during the study. Only those with stable mood stabilizer doses for at least two weeks prior to screening, and valproate treatment for at least seven months, are eligible. The treatment period lasts for 5 weeks. During the study, participants will be closely monitored through psychiatric evaluations and clinical assessments. Researchers will assess mania severity, safety, and any side effects. The main outcome is the change from baseline in the Young Mania Rating Scale score at Week 5. Participants’ physical health, including liver function and risk of urinary or gastrointestinal issues, will also be monitored to ensure safety throughout the trial.

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 efficacy and safety of cariprazine in treating adolescents aged 13 to 17 years with schizophrenia. This Phase 3 study compares cariprazine to a placebo to understand its effects on this population. Participants must have a confirmed diagnosis of schizophrenia based on DSM-5 criteria and meet specific symptom severity requirements. Participants receive either cariprazine or matching placebo capsules once daily by mouth for 6 weeks in a randomized, double-blind, parallel-group design. The study is conducted across multiple international centers to ensure diverse participation and data collection. Throughout the 6-week study, researchers assess changes in schizophrenia symptoms using the PANSS total score from baseline to Week 6. Safety and tolerability are also monitored closely. Participants will undergo clinical evaluations and symptom scoring to track progress and response to treatment during 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.

Researchers are evaluating ITI-1284 as an additional treatment for adults with Generalized Anxiety Disorder (GAD) who have not responded well to their current GAD treatment. This Phase 2, multicenter, randomized, double-blind, placebo-controlled study aims to assess the effectiveness, safety, and tolerability of ITI-1284 in this population. Participants must meet specific diagnostic criteria for moderate or severe GAD and have shown inadequate improvement from at least one approved GAD medication. The study consists of three periods: a screening phase lasting up to 3 weeks to confirm eligibility and allow for withdrawal of prohibited medications; a 6-week double-blind treatment period where participants are randomly assigned to receive ITI-1284 at 10 mg, ITI-1284 at 20 mg, or a placebo, all administered once daily as sublingual tablets; and a 1-week safety follow-up period to monitor participants after treatment ends. During the study, participants will be closely monitored with assessments including the Hamilton Anxiety Rating Scale at week 6 to measure anxiety levels. Other evaluations include clinical interviews and safety checks to ensure participant well-being. The study tracks treatment adherence and collects data on the safety and tolerability of ITI-1284 throughout the treatment and follow-up periods.

Researchers are evaluating ITI-1284 as a monotherapy treatment for adults diagnosed with moderate to severe Generalized Anxiety Disorder (GAD) who have not responded adequately to previous GAD treatments. This Phase 2, multicenter, randomized, double-blind, placebo-controlled study aims to assess the effectiveness, safety, and tolerability of ITI-1284 in this population. Participants must meet the DSM-5-TR criteria for GAD and have a significant level of anxiety as measured by clinical scales at screening and baseline. The study includes three periods: a screening period of up to 2 weeks to evaluate eligibility and allow washout from prohibited medications; a 6-week double-blind treatment period where about 570 participants are randomly assigned in equal groups to receive either ITI-1284 10 mg, ITI-1284 20 mg, or a matching placebo once daily via sublingual tablets; and a 1-week safety follow-up period after the last dose of the study drug. The treatments are administered once daily under blinded conditions. Participants will be involved in multiple assessments throughout the study, including evaluations of anxiety symptoms using the Hamilton Anxiety Rating Scale (HAM-A) at Week 6. Eligibility and safety are confirmed through structured interviews and clinical rating scales. Researchers will monitor treatment response, adverse events, and overall safety during the treatment and follow-up periods. The total participation duration includes screening, treatment, and safety follow-up visits.