Pico Rivera

Researchers are evaluating the long-term safety and tolerability of NBI-1065845 as an additional treatment for adults with Major Depressive Disorder MDD. This Phase 3, open-label study focuses on participants who have a primary diagnosis of recurrent moderate or severe MDD or persistent depressive disorder and have had an inadequate response to oral antidepressant treatments in their current depressive episode. Participants will receive NBI-1065845 tablets taken orally once daily as an adjunctive therapy alongside their ongoing antidepressant treatments. The study is designed as a single-group, open-label trial without placebo or comparison groups. The treatment period and follow-up extend over 52 weeks, during which safety and tolerability will be closely monitored. Throughout the study, participants will be assessed for treatment-emergent adverse events TEAEs from baseline through Week 52. Participants must be willing and able to comply with all study procedures and restrictions, including regular visits and evaluations determined by the investigators. The overall study duration allows for comprehensive monitoring of safety outcomes and participant well-being.

Researchers are evaluating the effects of NBI-1117568 on behavioral and psychological symptoms in adults diagnosed with schizophrenia who require inpatient hospitalization. This Phase 3 study compares NBI-1117568 to a placebo to assess its impact on symptom improvement. The trial is led by Neurocrine Biosciences and focuses on adults between 18 and 65 years old experiencing an acute episode or relapse of schizophrenia symptoms. Participants will be randomly assigned to receive either NBI-1117568 or a placebo once daily by mouth for 5 weeks, from Day 1 to Day 35. The study is designed as a double-blind, placebo-controlled trial, meaning neither the participants nor the researchers know which treatment is being given during the study period. During the study, participants will stay in an inpatient setting and be monitored closely. Researchers will measure changes in symptoms using the Positive and Negative Syndrome Scale PANSS total score at the beginning and end of the 5 weeks. They will also assess changes in severity using the Clinical Global Impression - Severity CGI-S score. Safety and tolerability will be tracked throughout the trial, which will continue until October 2027.

Researchers are evaluating the long-term safety and tolerability of a drug called NBI-1117568 in adults diagnosed with schizophrenia. This phase 3, open-label study aims to monitor participants over an extended period to better understand how the drug affects people with this condition and to gather important safety information. Participants in this study will take NBI-1117568 once daily by mouth for up to 36 months. This single treatment group will allow researchers to observe the effects of the medication over a long duration without comparing to a placebo or other treatments. During the study, researchers will track any treatment-emergent adverse events experienced by participants to assess safety. Participants will be monitored regularly throughout the 36 months for their health and response to the drug. This ongoing observation helps ensure participant well-being and collects valuable data on how the drug performs long-term.

Researchers are evaluating the effectiveness of iloperidone long-acting injection LAI compared to a placebo in preventing worsening symptoms in adults with schizophrenia. This is a Phase 3, double-blind, randomized withdrawal study sponsored by Vanda Pharmaceuticals, aiming to understand how well iloperidone LAI maintains symptom control in this population. The study begins with a 12-week stabilization phase where all participants receive open-label iloperidone, first as oral tablets for six weeks, followed by long-acting intramuscular injections for another six weeks. After stabilization, participants are randomly assigned to receive either iloperidone LAI or a matching placebo injection every few weeks for up to 52 weeks in a double-blind manner. Participants will be closely monitored throughout the study, including during the stabilization and randomized phases, to track the time until symptoms worsen. Researchers will assess changes in schizophrenia symptoms over the 52-week post-randomization period. Safety and adherence to the study drug will be observed, providing valuable information on the treatments ability to maintain symptom stability over time.

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.

Researchers are evaluating the efficacy of NBI-1065845 compared with a placebo as an additional treatment in adults with Major Depressive Disorder MDD. The study focuses on participants who have moderate to severe depression or persistent depressive disorder and who have not adequately responded to oral antidepressant treatments. This Phase 3, randomized, double-blind, placebo-controlled trial aims to assess how well NBI-1065845 improves symptoms of depression over the course of treatment. Participants will receive either NBI-1065845 tablets or matching placebo tablets, both administered orally once a day. The study treatment is given alongside participants ongoing oral antidepressant therapy, which they must continue at the same dose and frequency throughout the trial. The treatment period lasts for 56 days, during which participants are monitored closely. During the study, participants will undergo assessments including the Montgomery-sberg Depression Rating Scale MADRS to measure changes in depression symptoms, as well as evaluations using the Sheehan Disability Scale SDS and Clinical Global Impression-Severity Scale CGI-S at baseline and day 56. The trial includes safety monitoring and adherence to study procedures, with a total participation duration of at least 56 days.

Researchers are evaluating the safety, tolerability, and treatment response of GXV813 in adults hospitalized with schizophrenia who are experiencing an acute episode. This Phase 2a study aims to better understand how GXV813 affects symptoms of schizophrenia compared to a placebo in a controlled hospital setting. Participants will be randomly assigned to receive either GXV813 or a placebo, both given orally. The study uses a parallel-group design with quadruple masking to minimize bias. Treatment and observations will last for up to 6 weeks during hospitalization, focusing on symptom changes and drug pharmacokinetics. During the study, participants will be closely monitored with psychiatric assessments including the Positive and Negative Symptom Scale PANSS and Clinical Global Impression-Severity CGI-S scale. Researchers will also track safety, tolerability, and drug levels in the blood. The total participation time is about 6 weeks, with regular evaluations to measure changes from baseline symptoms and any adverse events.