Cedarhurst

Researchers are evaluating the safety, how the body processes, and effects on body weight of the investigational drug CRB-913 in participants with obesity. This Phase 1b study includes two parts: Part 1 focuses on healthy adults to measure drug levels in the blood after a single dose, while Part 2 involves obese participants to assess safety and weight effects using different doses compared to placebo. Part 2 is blinded so that participants, doctors, and the sponsor do not know who receives the drug or placebo. In Part 1, healthy adults receive a single dose of CRB-913 tablets to study how much of the drug enters the bloodstream and how long it stays. In Part 2, obese participants take one of three doses of CRB-913 or placebo once daily for 12 weeks. After treatment ends, participants are monitored for 28 days. The study includes a randomized, double-blind, placebo-controlled design for Part 2. Participants will attend study visits for drug administration, safety assessments, and blood tests to measure drug levels and effects on body weight. Researchers will monitor for side effects and adverse events from the first dose through 28 days after final dosing. The total participation time includes the 12-week treatment period plus the 28-day follow-up phase to evaluate safety and drug behavior in the body.

Researchers are studying the effects of zelquistinel, a drug being evaluated for treating major depressive disorder (MDD) in adults aged 18 to 64 years. This Phase 2 clinical trial aims to find out if zelquistinel can reduce depression symptoms compared to a placebo and to assess its safety. Participants diagnosed with MDD and meeting specific severity criteria will be enrolled to better understand the drug's impact on depression scores and potential side effects. Participants will be randomly assigned to receive either zelquistinel or a placebo tablet once a week for six weeks. The study is double-blind and placebo-controlled, meaning neither participants nor researchers know who receives the active drug. The trial includes up to 28 days of screening, a 42-day treatment period with weekly clinic visits, and a 4-week follow-up phase. During visits, depression severity is measured using the Hamilton Depression Rating Scale-17 (HDRS-17). Throughout the study, participants will attend weekly clinic visits for depression assessments and monitoring of adverse events. Researchers will track changes in depression scores from baseline to six weeks to evaluate effectiveness. Safety evaluations and follow-up assessments continue for four weeks after treatment. The total participation time may last up to 98 days, including screening, treatment, and follow-up.

Researchers are conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of azetukalner in adults diagnosed with bipolar I or II disorder who are currently experiencing a depressive episode. The study focuses on participants aged 18 to 74 years who have bipolar depression, aiming to better understand treatment effects in this population. Participants will be randomly assigned to receive either azetukalner at a dose of 20 mg or a placebo, both taken orally once daily with food, preferably with the evening meal. The treatment period lasts for 6 weeks, during which participants will be monitored closely. During the study, participants will undergo assessments including evaluation of depressive symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to Week 6. Researchers will monitor safety and treatment effects throughout the study. Total participation time covers the 6-week treatment period with ongoing monitoring of symptom changes and safety.

Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term gut conditions that cause symptoms like diarrhea, inflammation, bleeding, and belly pain. This research aims to see how many participants with UC or CD achieve remission, meaning their signs and symptoms disappear, after 14 weeks of treatment with Vedolizumab. This is a Phase 4 study evaluating the use of Vedolizumab in a community setting for moderate to severely active UC or CD. Participants will receive Vedolizumab treatment for about one year. During the first 6 weeks, the medication will be given through an intravenous infusion. After this period, treatment will continue with subcutaneous injections of Vedolizumab for the remaining weeks. If a participant's condition does not improve after 14 weeks, they will stop this treatment and may switch to another therapy. Additional visits are scheduled at 26 weeks and 52 weeks, with a follow-up assessment 18 weeks after the last dose. Throughout the study, participants will visit the clinic multiple times for monitoring. Researchers will assess remission using patient-reported outcome measures at week 14. Other evaluations include clinical checks and safety monitoring during treatment and after finishing the medication. The total study involvement can last over a year, including treatment and follow-up periods.

Researchers are evaluating the effects of ALTO-207 on adults with treatment-resistant depression (TRD). This Phase 2 trial compares ALTO-207 against a placebo to measure changes in depressive symptoms in participants who have moderate to severe major depressive disorder and have not responded adequately to previous antidepressant treatments. The goal is to understand how well ALTO-207 works in improving depression symptoms in this group. Participants will receive either ALTO-207 twice daily or a matching placebo. This randomized, double-blind, placebo-controlled trial involves treatment over a period of up to 8 weeks, during which symptom changes will be closely monitored. The study focuses on adults aged 18 to 75 who are already on stable doses of one or two oral antidepressants. During the study, participants will be assessed for changes in their depression severity using the MADRS (Montgomery-Åsberg Depression Rating Scale) from baseline up to 8 weeks. Researchers will monitor safety and symptom changes throughout the treatment period. Participants’ adherence to the treatment and overall health will also be observed to gather comprehensive data on the study outcomes.

Researchers are assessing the effectiveness of NBI-1117568 compared to a placebo in preventing relapse of schizophrenia symptoms in adults. This Phase 3 study focuses on individuals who have shown a stable response after initial open-label treatment with NBI-1117568. The study aims to determine how well NBI-1117568 delays the return of symptoms in this population. Participants receive either oral capsules of NBI-1117568 or a matching placebo in a double-blind, randomized withdrawal design. The treatment phase follows the open-label period where all participants initially receive NBI-1117568. This setup allows comparison of relapse times between those continuing the drug and those switched to placebo. Throughout the study, researchers monitor the time from randomization to symptom relapse for up to about 30 weeks. Participants undergo psychiatric evaluations and safety assessments to track tolerability and any adverse effects. The study includes adults aged 18 to 65 with stable schizophrenia who have responded to prior antipsychotic therapy, and it aims to provide detailed information on the safety and efficacy of NBI-1117568 over the treatment 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-1065845 compared to a placebo as an additional treatment for people with Major Depressive Disorder (MDD). The study focuses on participants who have moderate to severe depressive symptoms and have not responded adequately to oral antidepressant treatments during their current episode. This is a Phase 3 trial aiming to improve symptoms of depression by adding NBI-1065845 to existing antidepressant therapy. Participants will receive either NBI-1065845 tablets or matching placebo tablets alongside their current oral antidepressant medication, which they must continue at the same dose and frequency. The study compares these two groups to assess the added benefit of NBI-1065845 as an adjunctive therapy. During the study, participants will be assessed for changes in depression severity using the Montgomery-Åsberg Depression Rating Scale (MADRS) at baseline and on Day 56. Researchers will monitor safety and efficacy throughout the study period. Participants must comply with all study procedures and restrictions, with the total participation duration covering at least 56 days to evaluate 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.

Bipolar disorder is a serious, long-lasting mood condition affecting up to 4% of adults in the United States. This research aims to evaluate the safety and effectiveness of ABBV-932, an investigational drug, in treating adults with bipolar I or II disorder who are currently experiencing a depressive episode. The study is a phase 2, open-label trial conducted at about 50 sites across the United States and Puerto Rico, enrolling approximately 200 adults aged 18 to 65 years. Participants will take ABBV-932 as oral capsules during a 26-week treatment period. After this, there will be a 30-day safety follow-up period. The study focuses on monitoring the long-term safety and tolerability of ABBV-932 in this population, with attention to adverse events and other health measures. Throughout the study, participants will visit hospitals or clinics regularly for medical assessments, blood tests, and questionnaires to track side effects and treatment effects. Researchers will measure changes in vital signs, electrocardiograms, laboratory tests, movement scales, mental health scales, and ocular exams up to 26 weeks. The total participation duration includes the treatment and follow-up periods, ensuring ongoing safety monitoring.