Cedarhurst

Researchers are evaluating zelquistinel, a drug aimed at reducing symptoms of major depressive disorder in adults aged 18 to 64 years. This Phase 2 clinical trial compares the effects and safety of zelquistinel to a placebo in participants diagnosed with major depressive disorder. The study will focus on changes in depression severity and monitor any medical issues that arise during treatment. Participants will take one tablet of either zelquistinel or placebo once a week for six weeks. The trial includes a screening period of up to 28 days, followed by a 42-day treatment phase, and then a four-week follow-up period. During treatment, participants will visit the clinic weekly to receive their dose and have their depression symptoms assessed using the Hamilton Depression Rating Scale-17. Throughout the study, participants will have their depression severity regularly evaluated, along with monitoring for adverse events or side effects. The study lasts up to 98 days, including screening, treatment, and follow-up. Researchers will measure changes in depression scores from the beginning to the end of treatment and monitor overall safety during this time.

Researchers are evaluating the effects of azetukalner in adults diagnosed with bipolar I or II disorder who are currently experiencing a depressive episode, also known as bipolar depression. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to assess the safety and efficacy of azetukalner in this population. Participants must have had their first major depressive episode before age 50 and meet specific diagnostic criteria confirmed by clinical interview. Participants will be randomly assigned to receive either azetukalner 20 mg or a placebo orally once daily with food, preferably with the evening meal, for six weeks. The study has two groups one receiving the experimental drug and one receiving a placebo, both taken over the same period. The study is designed to keep participants and researchers unaware of the group assignments to ensure unbiased results. Throughout the trial, participants will be evaluated using various measures, including changes in depression severity assessed by the Montgomery-sberg Depression Rating Scale MADRS at baseline and at week 6, along with other scales at different time points. Safety and response will be monitored regularly during the six-week treatment period. The entire participation period is focused on this treatment phase, with assessments conducted to measure changes in symptoms and overall condition.

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.

Researchers are evaluating the use of Vedolizumab in adults with moderate to severely active Ulcerative Colitis UC or Crohns Disease CD, which are chronic gut conditions causing symptoms such as diarrhea, inflammation, bleeding, and abdominal pain. The study aims to measure how many participants achieve remission, meaning their symptoms disappear, after 14 weeks of treatment. This is a Phase 4 treatment study sponsored by Takeda, focusing on the effectiveness of Vedolizumab administered in a community setting. Participants with either UC or CD will receive Vedolizumab intravenously IV during the first 6 weeks, with doses given at Weeks 0 and 2, and possibly an additional IV dose at Week 6. After this initial period, participants may switch to subcutaneous under the skin injections of Vedolizumab every two weeks from Week 6 until Week 50. If the treatment does not appear effective by Week 14, participants may stop Vedolizumab and switch to another therapy. Additional required visits occur at 26 weeks and 52 weeks, with a final check 18 weeks after the last Vedolizumab dose. Throughout the study, participants will visit the clinic multiple times for treatment and monitoring. Assessments include patient-reported symptom measures at Weeks 6, 14, and 52, clinical response evaluations, and endoscopic examinations to observe mucosal healing. Blood and stool tests will measure inflammation markers like C-reactive protein and fecal calprotectin. Safety monitoring will track serious infections up to 72 weeks. Overall, participants are involved for about one year of treatment plus follow-up to evaluate the long-term effects of Vedolizumab.

Researchers are evaluating the effectiveness and safety of SPT-300 GlyphAllo, a drug being studied for adults with major depressive disorder MDD, including those with or without anxious distress. This is a phase 2, randomized, double-blind, placebo-controlled study designed to assess how well SPT-300 works and how well participants tolerate it. Participants will be randomly assigned to receive either SPT-300 capsules or a matching placebo once daily for 42 days. The study compares these two groups to understand the impact of SPT-300 as a monotherapy treatment for MDD. During the study, participants will be assessed for changes in depression severity using the Hamilton Depression Rating Scale-17 HAM-D-17 from the start to day 42 of treatment. Additional evaluations include clinical global impression severity scores. The trial includes monitoring for safety, tolerability, and other health measures throughout the 42-day treatment period.

Researchers are evaluating ALTO-207 compared to a placebo in adults with treatment-resistant depression TRD to measure changes in depressive symptoms. This phase 2 trial aims to better understand the effects of ALTO-207 on depression severity in participants who have not responded well to previous antidepressant treatments. Participants will be randomly assigned to receive either ALTO-207 twice daily or a matching placebo. The study is double-blind and placebo-controlled, ensuring that neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts up to 8 weeks, during which changes in depressive symptoms will be closely monitored. During the study, participants will undergo assessments including the Montgomery-sberg Depression Rating Scale MADRS to track changes in depression severity from the start through 8 weeks. Additional evaluations include response rates and clinical global impressions of severity over time. Safety and symptom monitoring will occur throughout, and participation may last up to 8 weeks based on treatment and follow-up visits.

Researchers are evaluating the drug NBI-1117568 in adults with schizophrenia to see if it can delay the return of symptoms after a stable response to initial treatment. This phase 3 study compares NBI-1117568 with a placebo in a randomized, double-blind format to assess both its effectiveness and safety. The trial is sponsored by Neurocrine Biosciences and focuses on adults aged 18 to 65 years who have been diagnosed with schizophrenia for at least one year and have previously responded to antipsychotic therapy other than clozapine. All participants first receive NBI-1117568 during an open-label stabilization period to achieve symptom control. After this, participants are randomly assigned to continue with either NBI-1117568 or a placebo during the double-blind treatment period, which lasts up to approximately 30 weeks. Both treatments are given as oral capsules, and the study uses a quadruple-blind design to ensure unbiased results. Participants will be closely monitored throughout the study for symptom relapse, with the primary outcome measuring the time from randomization to relapse. Assessments include psychiatric evaluations and safety checks to monitor tolerability of the drug. The total participation duration includes the stabilization phase and the double-blind treatment period, providing detailed information on the drugs ability to maintain symptom stability in schizophrenia over time.

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 studying the effects of NBI-1065845 compared with a placebo as an additional treatment for adults with Major Depressive Disorder MDD. This trial focuses on improving symptoms of depression in participants who have not responded well to standard oral antidepressant treatments during their current episode. The study is designed as a randomized, double-blind, placebo-controlled trial primarily evaluating treatment outcomes in this population. Participants will receive either NBI-1065845 tablets or placebo tablets that look identical. Both treatments are taken orally once a day alongside their current oral antidepressants, which participants must continue at the same dose and frequency throughout the study. The main treatment period lasts 56 days, during which researchers will monitor changes in depression symptoms and disability. Throughout the study, participants will undergo assessments including the Montgomery-sberg Depression Rating Scale MADRS, Sheehan Disability Scale SDS, and Clinical Global Impression-Severity Scale CGI-S at the start and end of the 56-day period. Researchers will evaluate changes in these scores to measure symptom improvement. The trial includes close monitoring to ensure participant safety and adherence, with total participation lasting about two months.

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.