Pico Rivera

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.

This research aims to evaluate the long-term safety and tolerability of NBI-1065845 when added to ongoing antidepressant treatment in adults diagnosed with Major Depressive Disorder (MDD). It focuses on participants who have experienced moderate or severe recurrent MDD or persistent depressive disorder and who have not responded adequately to oral antidepressants during their current depressive episode. This is a Phase 3, open-label study designed to monitor the effects of this adjunctive treatment over an extended period. Participants will receive NBI-1065845 tablets alongside their current oral antidepressant therapy. The study will observe treatment effects and monitor any adverse events that emerge during the course of therapy. There is no mention of a comparator or placebo group, indicating all enrolled individuals will be treated with NBI-1065845 in addition to their existing medication. The treatment and observation period extends through 52 weeks, allowing for comprehensive long-term safety assessment. During the study, participants will be regularly evaluated for treatment-emergent adverse events from the start through week 52. Researchers will track safety and tolerability through clinical assessments and monitoring. Participants must be willing and able to follow all study procedures and restrictions as determined by the investigators. The overall duration and detailed assessments ensure thorough monitoring of how well participants tolerate the adjunctive treatment over the course of one year.

Researchers are evaluating the effectiveness of NBI-1117568 compared with a placebo in improving behavioral and psychological symptoms in adults with schizophrenia who require inpatient hospitalization. This is a Phase 3, randomized, double-blind, placebo-controlled study focusing on patients experiencing an acute exacerbation or relapse of schizophrenia symptoms. The study aims to assess the drug's efficacy, safety, and tolerability in this population. Participants will receive either NBI-1117568 or a placebo according to a specified dosing schedule. All treatments are administered during an inpatient stay, and participants must remain hospitalized for the study duration. Those currently taking prohibited medications, including other antipsychotics, must discontinue them prior to starting the study. The study design ensures that neither the participants nor the researchers know who receives the active drug or placebo. During the study, participants will be monitored for changes in their schizophrenia symptoms, primarily measured by the Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 5. Participants will be evaluated regularly to track symptom changes and monitor safety. The study requires participants to comply with all protocol requirements while in the inpatient setting for the full duration of the trial, which includes careful observation and assessment of treatment effects.

Researchers are evaluating the long-term safety and tolerability of the drug NBI-1117568 in adults diagnosed with schizophrenia. This phase 3, global, multicenter, open-label study focuses on adults aged 18 to 65 years with a primary diagnosis of schizophrenia. The study aims to better understand how this medication performs over an extended period in this patient group. Participants will receive NBI-1117568 according to a specified dosing schedule. The treatment is administered openly, meaning both researchers and participants know the medication being given. No comparator or placebo group is mentioned, and the study primarily monitors the safety and side effects related to the drug over time. Throughout the study, participants will be closely monitored for any treatment-emergent adverse events for up to 36 months. Researchers will assess safety through regular evaluations and check participants' adherence to the protocol. The study includes careful screening and ongoing observation to ensure participant well-being and the collection of long-term safety data.

Researchers are evaluating the safety and effectiveness of up to two injections of REACT/rilparencel in adults with type 2 diabetes mellitus and chronic kidney disease. This phase 3 randomized controlled study divides participants into two groups to compare the effects of the actual treatment versus sham procedures mimicking kidney biopsy and injections. The goal is to monitor kidney function and clinical outcomes over time to understand the impact of this therapy on disease progression. Participants are randomly assigned before a kidney biopsy to either receive sham procedures or the real treatment involving a kidney biopsy followed by two rilparencel injections about 12 weeks apart, each into different kidneys. Those receiving sham procedures will undergo similar-sounding and looking activities without actual tissue removal or injection. All participants will be followed until the study's global end date, ensuring consistent long-term observation. During the study, participants will undergo kidney biopsies or sham procedures, followed by injections or sham injections. Researchers will assess kidney function by measuring the slope of estimated glomerular filtration rate (eGFR) over 18 months after the 135th participant's first injection or sham procedure. They will also track clinical events such as significant kidney function decline, need for dialysis or transplant, or renal and cardiovascular deaths for up to 94 months. Safety and efficacy will be monitored throughout the study to evaluate treatment impact.

Researchers are evaluating the effectiveness of iloperidone long-acting injection (LAI) compared to a placebo in preventing worsening symptoms in adults with schizophrenia. This Phase 3 study focuses on patients who require ongoing psychiatric treatment and seeks to understand how well iloperidone LAI can maintain symptom control over time. Participants in the study are randomly assigned to receive either iloperidone LAI or a matching placebo injection. The treatments are administered as injections, and the study is conducted in a double-blind manner, meaning neither the participants nor the researchers know who receives the active drug or placebo during the study. During the study, participants are monitored for up to 52 weeks after randomization to track the time until any worsening or exacerbation of schizophrenia symptoms. Researchers will assess symptom control and safety throughout this period to evaluate the treatment's effects and maintain participant well-being.

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 the effectiveness of the drug NBI-1065845 compared with a placebo as an additional treatment for adults with Major Depressive Disorder (MDD). This phase 3 study focuses on participants who have moderate to severe recurrent MDD or persistent depressive disorder and who have not adequately responded to oral antidepressant treatments during their current depressive episode. Participants will be randomly assigned to receive either NBI-1065845 tablets or matching placebo tablets alongside their existing oral antidepressants, which they must continue at the same dose and frequency throughout the study. This double-blind, placebo-controlled trial will monitor changes over a period leading up to day 56. During the study, participants' depression symptoms will be assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS) at baseline and on day 56. The study will also monitor safety and adherence to the treatment plan. Researchers aim to measure improvement in depression symptoms as the main outcome of treatment effectiveness.

This research aims to evaluate the efficacy, safety, and tolerability of the drug GXV813 in treating adults hospitalized with an acute episode of schizophrenia. It is a Phase 2a study that compares GXV813 with a placebo in adults diagnosed with schizophrenia according to DSM-5 criteria. Participants must be experiencing a recent acute exacerbation or relapse of psychotic symptoms requiring hospitalization. Participants will receive either GXV813 or placebo orally while hospitalized. The study is randomized, blinded for both participants and investigators, and involves parallel groups. The treatment period focuses on the acute episode, with participants being confined to the inpatient setting during this time. After treatment, a follow-up period occurs outside the hospital. During the study, researchers will monitor changes in the Positive and Negative Symptom Scale (PANSS) total score from baseline to Week 6 to assess treatment response. Participants will undergo psychiatric evaluations, and their adherence and safety will be closely observed throughout the study. The total participation period includes hospitalization for treatment and a subsequent follow-up phase to assess ongoing outcomes.