Richmond County

Researchers are conducting a 52-week open-label study to evaluate the long-term safety, tolerability, and effectiveness of ML-007C-MA in adults with schizophrenia. This study includes participants who have recently completed a prior study ML-007C-MA-211 as well as new participants enrolling directly. The goal is to better understand how ML-007C-MA performs over an extended period in managing schizophrenia symptoms. Participants will receive ML-007C-MA dosed as 2103 mg twice daily throughout the 52-week treatment period. The study is designed as an open-label trial, meaning both researchers and participants know the treatment being administered. No placebo or comparator groups are involved in this phase 2 research. During the study, participants will undergo assessments to monitor safety and tolerability from the initial dose through the end of treatment. Researchers will also evaluate the effectiveness of ML-007C-MA in managing schizophrenia symptoms. The study involves outpatient care, regular clinical interviews, and the involvement of reliable informants to support assessments. Participants will be observed for up to one year to gather comprehensive data on long-term treatment outcomes.

Researchers are evaluating the safety and effectiveness of KarXT combined with KarX-EC in adults aged 55 to 90 who experience agitation related to Alzheimers Disease. This Phase 3 study aims to understand how these medications impact agitation symptoms in this population, using recognized criteria to confirm Alzheimers diagnosis and agitation severity. Participants will be randomly assigned to receive either the combination of KarXT and KarX-EC or a placebo. Dosing is specified for certain days, and the study includes a 14-week treatment period during which agitation and other symptoms will be closely monitored. The study design includes a quadruple-blind method to reduce bias. During the study, participants and their caregivers will attend regular visits where the researchers will assess changes in agitation using tools like the Cohen-Mansfield Agitation Inventory and Clinical Global Impressions-Severity scale. Safety will also be carefully monitored through various assessments including vital signs, lab tests, ECGs, and movement scales. Participant involvement extends up to 18 weeks to capture any adverse events and treatment effects.

Researchers are evaluating the safety and effectiveness of the Vagus Nerve Stimulation VNS Therapy System as an additional treatment for people with treatment-resistant depression. This prospective, multi-center, randomized, controlled, and blinded trial compares active VNS therapy to a no stimulation control group in reducing depressive symptoms over 12 months. The study follows guidelines aligned with Medicare and Medicaid coverage decisions for VNS in this condition. Participants receive an implant of the VNS device and are randomized at least two weeks after implantation to either have the device activated or remain without stimulation for the first 12 months. After this initial period, those in the control group can begin stimulation. Following the 12-month randomized phase, all participants enter an open-label, longitudinal study lasting about five years, including new enrollees after the initial trial phase. During the study, participants are monitored through various depression rating scales, including the Montgomery sberg Depression Rating Scale MADRS, to assess response and remission rates up to 12 months. Safety is tracked by recording adverse events from implantation through the first year. Additional assessments include disability and health outcome scales, as well as suicidality tracking. The study aims to gather long-term data on treatment effects and participant well-being.

Researchers are evaluating azetukalner as a monotherapy in adults diagnosed with Major Depressive Disorder MDD. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to assess the clinical efficacy, safety, and tolerability of azetukalner compared to placebo in adults with moderate-to-severe MDD. Participants are adults aged 18 to 74 years with a current major depressive episode lasting between 6 weeks and 24 months. Participants will be randomly assigned to receive either azetukalner 20 mg or placebo, both taken orally once daily with food, preferably with the evening meal, for 6 weeks. The study uses a parallel design and includes a placebo comparator. Azetukalner and placebo are administered as daily oral doses over the treatment period. During the study, participants will undergo assessments including the Hamilton Depression Rating Scale HAMD-17 at baseline, Week 1, and Week 6, the Snaith-Hamilton Pleasure Scale SHAPS, and the Clinical Global Impression of Severity CGI-S score at Week 6. Safety and tolerability are monitored from screening through 8 weeks after the final dose. The primary outcome is the change from baseline in HAMD-17 at Week 6. Total participation may last several months, including screening, treatment, and follow-up periods.

Researchers are evaluating LY3457263 compared with a placebo in adults with type 2 diabetes who have not reached their hemoglobin A1c HbA1c goal despite being on stable doses of semaglutide or tirzepatide. This Phase 2, double-blind study focuses on measuring changes in HbA1c levels. Participation in the trial lasts about nine months, aiming to provide insights into treatment effects in this specific patient group. Participants will be randomly assigned to receive one of three doses of LY3457263 or a placebo, all given by subcutaneous injection once weekly. The study uses a parallel-group design where each participant receives only one assigned treatment. The trial compares these treatments over a 24-week period to assess their impact on blood sugar control and body weight. During the study, participants will undergo regular assessments including blood tests to measure HbA1c and fasting serum glucose, as well as body weight measurements. These evaluations occur at baseline and at 24 weeks. The study team will monitor participants health and treatment effects throughout the trial, which is expected to last about nine months in total.

Researchers are evaluating the safety, tolerability, and feasibility of aticaprant as an additional treatment for adults with schizophrenia. This phase 1b study aims to see how well participants with schizophrenia can enroll and complete the study assessments while comparing aticaprant to a placebo. The study focuses on participants who are clinically stable and already receiving outpatient treatment for schizophrenia. Participants are randomly assigned to receive either aticaprant or a placebo during the double-blind treatment phase. The study involves monitoring participants over several weeks, with safety and tolerability assessments including adverse events, vital signs, ECGs, laboratory tests, body weight and BMI changes, suicidality assessments, and extrapyramidal symptom evaluations. The study is designed to last up to 126 days for most outcomes, with some measurements taken up to 84 days. Throughout the study, participants will undergo various assessments to evaluate safety and tolerability, including the Columbia Suicide Severity Rating Scale and the Modified Simpson-Angus Scale for extrapyramidal symptoms. Blood samples will confirm medication adherence, and the study will track completion rates of assessments and overall study participation. This detailed monitoring helps researchers understand how participants tolerate aticaprant as an add-on therapy in schizophrenia treatment.

This trial studies adults aged 55 to 90 who have psychosis linked to Alzheimers Disease. It is a Phase 3, 38-week, randomized, double-blind, placebo-controlled outpatient study. Its main goal is to assess how well KarXT capsules prevent relapse of psychosis compared to placebo. Additional goals include evaluating time to treatment discontinuation or relapse, and monitoring safety and tolerability. Participants receive either KarXT capsules at various doses or placebo capsules. The study involves a randomized assignment and is conducted under quadruple masking. The treatment period lasts 38 weeks during which KarXT or placebo is taken three times daily. Assessments continue up to approximately 42 weeks to monitor adverse events and other safety measures. Throughout the study, participants attend outpatient visits for evaluations including cognitive tests, assessments of psychosis severity, caregiver reports, lab tests, vital signs, and safety monitoring. Researchers measure relapse timing, treatment discontinuation, neuropsychiatric symptoms, movement scales, weight, and signs related to heart and urinary health. Safety is closely tracked with various assessments until about week 42.

Researchers are conducting a phase 3, open-label extension study to assess the long-term safety and tolerability of KarXT for treating mania or mania with mixed features in adults with Bipolar-I disorder. The study focuses on evaluating how participants respond to KarXT over an extended period, emphasizing safety measurements such as adverse events and symptom changes. Participants will receive KarXT at specified doses over a treatment period lasting up to 54 weeks. This study includes participants previously involved in related placebo-controlled studies as well as new participants diagnosed with Bipolar-I disorder with manic symptoms. The treatment may be given alongside standard therapeutic doses of lithium, valproate, or lamotrigine as applicable. Throughout the study, participants will undergo regular assessments including monitoring of treatment emergent adverse events, serious adverse events, and psychiatric symptom scales like the Columbia-Suicide Severity Rating Scale, Young Mania Rating Scale, and others. Safety and tolerability will be closely tracked, with evaluations occurring up to week 54. The entire participation may last until the study end date in June 2028, ensuring comprehensive long-term follow-up.

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 KarXT for the treatment of manic episodes in adults with Bipolar-I Disorder. This Phase 3, randomized, double-blind, placebo-controlled study involves participants experiencing an acute episode of mania or mania with mixed features. The study aims to compare the effectiveness and safety of KarXT against a placebo during a 3-week inpatient treatment period. Participants will receive flexible dosing of either KarXT or placebo during the 3-week double-blind inpatient phase. Before treatment, psychotropic medications must be washed out within 14 days. The study includes screening, the treatment period, and a safety follow-up, totaling no more than seven weeks. During the study, participants will have their symptoms assessed using tools such as the Young Mania Rating Scale and Clinical Global Impressions-Bipolar scale. Researchers will monitor changes in mania symptoms and overall clinical impression at week 3. Safety follow-up continues after treatment to ensure participant well-being throughout the study duration.