Targovishte

This research aims to evaluate the effectiveness and safety of adding KarXT to current treatment for mania in adults with Bipolar-I Disorder. Participants must be experiencing an acute manic episode, with or without mixed features, and currently taking lithium, valproate, or lamotrigine. The study is a Phase 3, randomized, double-blind, placebo-controlled trial assessing KarXT as an adjunctive therapy. Participants will be randomly assigned to receive either KarXT combined with lithium, valproate, or lamotrigine, or a placebo combined with these mood stabilizers. The study drug or placebo will be administered at specified doses on designated days. The trial focuses on treatment during an acute manic episode with monitoring over several weeks to assess changes in mania symptoms and other clinical outcomes. Participants will be monitored through scheduled visits where researchers will measure changes in mania severity using the Young Mania Rating Scale YMRS and other clinical scales. Safety assessments will include tracking adverse events and evaluating other symptom scales related to bipolar disorder. The total study duration includes treatment and follow-up periods lasting up to seven weeks, during which participants health and responses to the study drug are carefully observed.

Researchers are evaluating the efficacy and safety of cariprazine in treating schizophrenia among adolescents aged 13 to 17 years. This international, multicenter study is designed as a randomized, double-blind, placebo-controlled trial to understand how cariprazine affects symptoms of schizophrenia in this younger population. Participants will be randomly assigned to receive either cariprazine capsules at doses of 1.5 mg or 4.5 mg once daily, or matching placebo capsules once daily. The treatment phase lasts for six weeks, during which participants take the assigned capsules orally every day. During the study, participants will be monitored regularly to assess changes in their schizophrenia symptoms using the Positive and Negative Syndrome Scale PANSS. Researchers will also evaluate safety and tolerability throughout the trial. The main measurement is the change in PANSS total score from the start to the end of the six-week period. The study is designed to last until December 2026.

Researchers are evaluating the efficacy and safety of milsaperidone as an additional treatment for patients with Major Depressive Disorder MDD who have not responded adequately to antidepressant therapy. This Phase 3, randomized, double-blind, placebo-controlled study aims to compare milsaperidone with a placebo to better understand its potential benefits and risks in this population. The study involves two groups one receiving oral milsaperidone and the other receiving an oral placebo. Participants will be randomly assigned to one of these groups, and neither they nor the researchers will know which treatment is given during the study. This design helps ensure unbiased results about how milsaperidone performs as an add-on therapy compared to placebo. Participants will be involved in the study for at least six weeks, during which their depression symptoms will be assessed using the Montgomery-Asberg Depression Rating Scale MADRS to measure changes from baseline. The study will monitor safety and effectiveness closely throughout this period. The trial is sponsored by Vanda Pharmaceuticals and is expected to run until March 2028.

Researchers are evaluating the drug NBI-1117570 for its effects on behavioral and psychological symptoms in adults with schizophrenia who need inpatient hospitalization. This phase 2a study compares NBI-1117570 to a placebo to assess its efficacy, safety, tolerability, and how the drug is processed in the body. Participants will be randomly assigned to one of three groups a lower-dose NBI-1117570 group, a higher-dose NBI-1117570 group, or a placebo group. The drug and placebo are given orally. The study uses a parallel design with quadruple masking to maintain blinding. The primary treatment period lasts 35 days, after which safety and adverse events are monitored up to 49 days. During the study, participants will have assessments to measure changes in schizophrenia symptoms using the Positive and Negative Syndrome Scale PANSS. Researchers will also track any treatment-emergent adverse events throughout the treatment and follow-up periods. The trial is sponsored by Neurocrine Biosciences and runs from February 2026 to August 2027.

Researchers are evaluating the effectiveness, safety, and tolerability of ITI-1284 as an additional treatment for adults with generalized anxiety disorder GAD who have not responded well to their current GAD medications. This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial conducted by Intra-Cellular Therapies, Inc. Participants must meet specific diagnostic criteria for moderate to severe GAD and show inadequate response to standard treatments. The study consists of three periods a screening phase lasting up to 3 weeks to assess eligibility and allow for medication washout a 6-week double-blind treatment phase where participants are randomly assigned to receive either ITI-1284 at 10 mg, ITI-1284 at 20 mg, or a placebo, all given once daily as sublingual tablets and a 1-week safety follow-up period. Participants continue their existing GAD treatment during the study. During the trial, participants will undergo various assessments including anxiety severity ratings using the Hamilton Anxiety Rating Scale HAM-A and the Clinical Global Impression Scale-Severity CGI-S at week 6. Safety and tolerability will be monitored throughout, with a follow-up visit after the treatment phase. Overall participation spans approximately 10 weeks including screening and follow-up.

Researchers are evaluating the safety, tolerability, and effectiveness of ITI-1284 as a single treatment for adults with moderate to severe Generalized Anxiety Disorder GAD who have not adequately responded to previous treatments. This Phase 2 study is randomized, double-blind, and placebo-controlled, designed to compare different doses of ITI-1284 with a placebo. The study aims to address the needs of patients meeting DSM-5-TR criteria for GAD with a history of insufficient response to approved medications. The trial includes three periods a screening period lasting up to 2 weeks to assess eligibility and medication washout a 6-week double-blind treatment period where about 570 patients are randomly assigned 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 after the last dose. Participants take their assigned tablets daily under blinded conditions to evaluate the treatment effects. Participants will undergo assessments using the Hamilton Anxiety Rating Scale HAM-A and the Clinical Global Impression Scale-Severity CGI-S at 6 weeks to measure anxiety severity and overall clinical status. Safety monitoring includes a follow-up visit about one week after treatment ends. The total participation time covers screening, treatment, and safety follow-up, with evaluations conducted at specified intervals to monitor response and tolerability.