Novi Knezevac

Researchers are evaluating ITI-1284, a drug being studied for agitation associated with Alzheimers dementia. This Phase 2, multicenter, randomized, double-blind, placebo-controlled study aims to assess the efficacy, safety, and tolerability of ITI-1284 in patients aged 55 years and older who experience agitation related to Alzheimers disease. The study is sponsored by Intra-Cellular Therapies, Inc. and follows strict clinical criteria for diagnosis and agitation severity. Participants are randomly assigned in equal numbers to receive either ITI-1284 or a placebo. ITI-1284 is given as a rapidly disintegrating tablet taken once daily under the tongue at doses of 10 mg or 20 mg. The study consists of three periods a screening period lasting up to 4 weeks to assess eligibility, a 12-week double-blind treatment period where the assigned study drug is taken daily, and a 30-day safety follow-up period after the last dose to monitor any effects. During the study, participants will have assessments including the Cohen-Mansfield Agitation Inventory CMAI to measure agitation levels at Week 12. Other evaluations include the Clinical Global Impression-Severity CGI-S score and cognitive testing with the Mini-Mental State Examination. Safety monitoring occurs throughout the treatment and follow-up periods. Overall, participation lasts approximately 16 to 17 weeks, covering screening, treatment, and safety checks.

Researchers are evaluating ITI-1284, a study drug, for treating psychosis in patients with Alzheimers disease. This multicenter, randomized, double-blind study compares ITI-1284 with a placebo to assess its efficacy, safety, and tolerability in this population. The study includes patients diagnosed with Alzheimers disease and associated psychosis, focusing on improving psychosis symptoms as measured by specific scales. Participants will be randomly assigned to receive either ITI-1284 or a placebo during a 6-week double-blind treatment period. ITI-1284 is given as a 10 mg or 20 mg tablet taken once daily under the tongue. Before treatment, there is a screening period lasting up to 4 weeks to determine eligibility. After treatment, a safety follow-up visit occurs approximately 30 days later to monitor any effects. During the study, participants will undergo various assessments including psychosis rating scales BEHAVE-AD psychosis subscale and CGI-S score at baseline and Week 6. Researchers will monitor safety, tolerability, and adherence throughout treatment and follow-up. The total participation time includes screening, treatment, and the 30-day safety follow-up period, allowing detailed evaluation of the study drugs impact and participant well-being.

Researchers are evaluating ACP-204, a drug targeting serotonin receptor subtype 2A, in adults aged 55 to 95 years with psychosis related to Alzheimers disease. This master protocol includes three independent, randomized, double-blind, placebo-controlled studies aimed at assessing the drugs efficacy and dose response. Substudy 1 is a Phase 2 trial comparing two doses of ACP-204 30 mg and 60 mg to placebo, followed by two Phase 3 confirmatory studies Substudies 2A and 2B that will independently evaluate the doses or a selected dose against placebo. Participants will undergo a screening period lasting up to 49 days before starting a six-week double-blind treatment phase where they will receive daily doses of ACP-204 or placebo, taken once a day at about the same time with or without food. After treatment, there is a 30-day safety follow-up for those not entering an open-label extension, and vital status follow-up for those who end the study early. Each substudy is analyzed separately to assess the drugs impact. During the trial, participants are closely monitored with assessments including the Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions SAPS-HD from baseline to week 6. Other evaluations include clinical global impression scales and safety monitoring. Participants must have a study partner or caregiver to assist with visits and adherence. The study is designed to track changes in psychosis symptoms and overall safety through the treatment and follow-up periods.

Researchers are evaluating the effect of seltorexant as an add-on treatment to antidepressants in adults and elderly people with major depressive disorder who also have insomnia symptoms and have not responded well to their current antidepressant therapy with SSRIs or SNRIs. This Phase 3 study aims to understand how well seltorexant works, its safety, and its ability to maintain improvement compared with a placebo. Participants in part 1 of the study will receive either seltorexant or a matching placebo once daily for 6 weeks, alongside their usual SSRI or SNRI antidepressant. Those who complete part 1 and meet criteria for part 2, plus new participants entering directly into part 2, will receive seltorexant during an open-label induction and stabilization phase. Participants who respond well will then enter a double-blind maintenance phase, receiving either seltorexant or placebo daily, continuing their baseline antidepressant throughout. During the study, participants will be monitored through rating scales measuring depression severity, sleep disturbance, and patient health questionnaires at baseline and specified days up to two years and ten months. Researchers will assess changes in depression symptoms and time to relapse, along with safety and tolerability. Participants will be followed through treatment phases and post-treatment periods to evaluate the maintenance of effects and overall safety.

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.

Researchers are conducting a multicenter, randomized, double-blind, placebo-controlled study to evaluate lumateperone as an additional treatment for adults with Major Depressive Disorder MDD who have not responded well to ongoing antidepressant therapy. The study focuses on patients diagnosed with MDD according to DSM-5 criteria, including those with psychotic features, who have experienced an inadequate response to at least two antidepressant treatments during their current major depressive episode. Participants will be randomly assigned to receive either lumateperone 42 mg capsules or matching placebo capsules taken orally once daily for six weeks during the double-blind treatment period. The trial includes three periods a screening period of up to two weeks to assess eligibility, the six-week treatment period, and a one-week safety follow-up period after the last dose to monitor participant safety. During the study, participants will undergo assessments including depression severity ratings using the Montgomery-Asberg Depression Rating Scale and the Clinical Global Impression Scale. Researchers will monitor symptoms, treatment adherence, and safety throughout the treatment and follow-up periods. Total participation spans approximately nine weeks, covering screening, treatment, and safety monitoring.