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Researchers are evaluating the effectiveness, safety, and tolerability of ITI-1284 for people with agitation linked to Alzheimer's dementia. This Phase 2, multicenter, randomized, double-blind, placebo-controlled study aims to compare ITI-1284 to a placebo in patients aged 55 years and older who meet specific criteria for Alzheimer's disease and agitation. Participants will be involved in three main periods: a screening phase of up to 4 weeks to confirm eligibility; a 12-week double-blind treatment phase where patients will be randomly assigned to receive either ITI-1284 (10 mg or 20 mg) or a placebo, both given once daily as a rapidly disintegrating tablet under the tongue; and a 30-day safety follow-up period after the last dose to monitor any safety concerns. During the study, participants will undergo various assessments including agitation severity measured by the Cohen-Mansfield Agitation Inventory at Week 12. Other evaluations include cognitive testing, clinical global impressions, and monitoring for side effects. Researchers will track adherence and safety through visits and questionnaires over the total study duration, which includes screening, treatment, and follow-up.

Researchers are evaluating the effectiveness, safety, and tolerability of ITI-1284 compared to a placebo in treating psychosis associated with Alzheimer's disease. This Phase 2, multicenter, randomized, double-blind, placebo-controlled study focuses on patients aged 55 and older who meet specific clinical criteria for Alzheimer's disease and psychosis. The study aims to assess changes in psychosis symptoms using the BEHAVE-AD psychosis subscale score after 6 weeks of treatment. Participants will be randomly assigned in equal numbers to receive either ITI-1284 or a placebo. ITI-1284 is administered as a rapidly disintegrating tablet taken once daily under the tongue at doses of 10 mg or 20 mg. The study includes three periods: up to 4 weeks of screening to determine eligibility, a 6-week double-blind treatment phase where participants receive their assigned medication, and a 30-day safety follow-up after the last dose to monitor any adverse effects. During the study, participants will undergo assessments to confirm Alzheimer's disease diagnosis and psychosis presence, including biomarker tests, clinical rating scales, and cognitive evaluations. Caregivers will be involved as designated support persons. Researchers will monitor symptom changes, safety, and tolerability throughout the treatment and follow-up periods. The primary outcome is the psychosis subscale score measured at week 6, with safety follow-up visits approximately 30 days after treatment ends.

Researchers are evaluating ACP-204, a drug that blocks a specific serotonin receptor, in adults aged 55 to 95 with Alzheimer's Disease Psychosis (ADP). The study is designed as a master protocol with three independent, multicenter, randomized, double-blind, placebo-controlled trials. The trials include Phase 2 and Phase 3 studies to assess the drug's effectiveness and safety in treating psychotic symptoms associated with ADP. The research involves three substudies. Substudy 1 (Phase 2) tests two doses of ACP-204, 30 mg and 60 mg, against a placebo to evaluate dose response. Substudies 2A and 2B (both Phase 3) will independently confirm the effects of either both doses or a single dose from Part 1 compared to placebo. Each substudy includes a screening period of up to 49 days, a six-week double-blind treatment phase, and a 30-day safety follow-up for those not continuing into an open-label extension. Vital status follow-up is conducted for participants who end the study early. Participants will receive regular assessments, including evaluations of psychotic symptoms using the Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales from baseline to Week 6. Other study involvement includes brain imaging scans and biomarker tests to confirm Alzheimer's disease diagnosis, cognitive testing, and monitoring of safety and vital status throughout the study periods. Stable living arrangements and support from a caregiver are required to complete all study visits.

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 how well seltorexant works and its safety as an added treatment to antidepressants in adults and elderly participants who have major depressive disorder with insomnia symptoms (MDDIS). The study focuses on people who have not responded adequately to current antidepressant therapy with selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). This Phase 3 trial aims to assess the improvement of depressive symptoms and the maintenance effect of seltorexant compared to a placebo. Participants will receive either seltorexant or a matching placebo taken orally alongside their current antidepressant medication, which includes SSRIs or SNRIs. The study is divided into two parts: Part 1 evaluates changes in depression severity after 43 days, while Part 2 monitors the time to relapse for up to nearly three years in participants who achieved a stable response. Participants must continue their stable antidepressant dose during the study. During the study, participants will be assessed using the Montgomery-Asberg Depression Rating Scale to measure changes in depression symptoms and monitored for relapse over time. Safety and tolerability will also be evaluated throughout. The total participation includes an initial treatment phase and an extended maintenance phase, allowing researchers to understand both short-term and long-term effects of seltorexant as an adjunctive therapy.

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.

Researchers are evaluating lumateperone as an additional treatment for adults aged 18 to 65 with major depressive disorder (MDD) who have not responded adequately to current antidepressant therapy. This phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to assess the effectiveness and safety of lumateperone in patients diagnosed according to the DSM-5 criteria, including those with psychotic features. Participants must have moderate to severe depression and an ongoing major depressive episode lasting between 12 weeks and 18 months. Participants will be randomly assigned to receive either lumateperone 42 mg capsules or matching placebo capsules once daily during a six-week double-blind treatment period. Before treatment, there is a screening period of up to two weeks to confirm eligibility. After the treatment phase, there is a one-week safety follow-up visit to monitor participants after completing the study medication. Throughout the study, patients will be assessed using depression rating scales including the Montgomery-Asberg Depression Rating Scale (MADRS). Other evaluations include psychiatric interviews, symptom questionnaires, and safety monitoring for suicidal thoughts or behaviors. The study tracks changes in depression severity and safety outcomes from screening through treatment and follow-up, totaling approximately nine weeks of participation.

Researchers are evaluating lumateperone for the acute treatment of patients diagnosed with bipolar I disorder experiencing manic episodes or manic episodes with mixed features, with or without psychotic symptoms. This phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to assess the efficacy and safety of this treatment in such patients based on established diagnostic criteria from the DSM-5. The study consists of three phases: a screening period lasting up to one week to assess patient eligibility; a double-blind treatment period of three weeks where eligible patients are randomly assigned in a 1:1 ratio to receive either lumateperone 42 mg capsules or placebo capsules once daily; and a safety follow-up period of one week during which all patients return to the clinic for safety monitoring. Participants will undergo evaluations including the Young Mania Rating Scale (YMRS) at week 3 to measure treatment outcomes. Safety follow-up visits occur one week after treatment to monitor any adverse effects. The total study duration for each participant includes screening, treatment, and safety follow-up, ensuring thorough assessment of both efficacy and safety throughout the trial.

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.