Kazanlak

Researchers are evaluating the effectiveness of DT-101 in treating adults with Major Depressive Disorder (MDD). This Phase 2 clinical trial compares DT-101 to a placebo to understand its impact on depression symptoms and evaluates the safety and tolerability of the study drug. Participants have recurrent depression diagnosed by the latest DSM manual and are between 18 and 75 years old. Participants will receive either DT-101 or placebo in a double-blind, randomized manner. The study includes physical and neurological examinations, blood and urine sample collections, and clinical assessments to monitor ongoing suitability and gather data on the drug's effects. Blood samples will also be used to study how DT-101 is absorbed and metabolized and to explore genetic factors that may influence treatment response. During the study, participants will visit the clinic every few weeks to undergo general health checks and complete questionnaires. Researchers will measure changes in depression using the Montgomery Åsberg Depression Rating Scale (MADRS) from the start of the study to Day 42. Safety and adherence will be closely monitored throughout the trial, ensuring participant well-being and data accuracy.

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 lumateperone as a treatment for adults diagnosed with bipolar I disorder experiencing manic episodes or manic episodes with mixed features, with or without psychotic symptoms. This phase 3, multicenter study is randomized, double-blind, and placebo-controlled, aiming to assess the efficacy and safety of lumateperone in this acute setting. The study has three phases: a screening period lasting up to one week to assess eligibility; a double-blind treatment period of three weeks during which participants are randomly assigned to receive either lumateperone 42 mg capsules or matching placebo capsules orally once daily; and a safety follow-up period of one week where all participants return to the clinic for safety evaluations. Participants will be involved in assessments including the Young Mania Rating Scale at week 3 to measure treatment effects. Eligibility evaluations, safety monitoring, and follow-up visits are conducted throughout the study. The total participation duration includes screening, treatment, and safety follow-up over approximately five weeks.