Bentonville

Researchers are evaluating the clinical efficacy, safety, and tolerability of azetukalner as a monotherapy in adults diagnosed with moderate-to-severe Major Depressive Disorder (MDD). This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on participants aged 18 to 74 who have experienced their first major depressive episode before age 50. The study aims to compare azetukalner with placebo in treating MDD over a 6-week period. Participants will receive either azetukalner 20 mg or placebo orally once a day with food, preferably with the evening meal, for 6 weeks. The treatment is administered as a daily oral dose, and participants are randomly assigned to one of the two groups. The study is designed to maintain blinding of treatments to both participants and researchers. During the study, participants' depression symptoms will be assessed using the Hamilton Depression Rating Scale (HAMD-17) to measure changes from baseline to Week 6. Researchers will also monitor safety and tolerability throughout the treatment period. Participants will undergo regular evaluations, and the study includes careful screening to ensure eligibility and monitor any adverse effects during the 6 weeks of treatment.

Bipolar disorder is a serious and long-lasting mood disorder affecting both adults and children, with up to 1.8% of the pediatric population in the United States affected. Treatment options for depressive episodes in children with bipolar disorder are limited due to fewer studies compared to adults. This research aims to evaluate how cariprazine affects disease symptoms and safety in children and teenagers aged 10 to 17 years who have bipolar I disorder with depressive episodes. Participants in the study will be randomly assigned to one of two groups: one receiving cariprazine and the other receiving a placebo, with about half of the participants in each group. Cariprazine will be given as oral capsules in doses adjusted based on age and weight. At the third week, doses may be increased for those not responding well, while others will continue their current dose. The treatment lasts 6 weeks, followed by a 4-week safety follow-up period. During the study, participants will attend weekly visits to hospitals or clinics for medical assessments, blood tests, and questionnaires to monitor side effects and treatment effects. Researchers will measure changes in depression scores and monitor for any adverse events or abnormal clinical signs, including vital signs, ECG, and movement disorders. The total study duration includes the treatment and safety follow-up periods, ensuring careful observation of participants' health and response to treatment.

Researchers are evaluating the long-term safety and tolerability of KarXT in treating mania or mania with mixed features in adults with Bipolar-I disorder. This phase 3, open-label extension study aims to better understand how KarXT performs over an extended period in this population. The study includes participants who either completed previous double-blind placebo-controlled studies or are newly diagnosed with Bipolar-I disorder experiencing manic symptoms. Participants receive KarXT at specified doses on certain days, with some also taking therapeutic doses of Lithium, Valproate, or Lamotrigine as part of their treatment. The study does not mention a placebo group during this extension, focusing instead on monitoring the long-term effects of KarXT alone or in combination with these established therapies. During the study, participants are monitored for adverse events up to week 54 to assess safety. Evaluations include psychiatric assessments using scales such as the Young Mania Rating Scale and CGI-BP score at screening and baseline. Researchers will track treatment-emergent adverse events and overall tolerability throughout the study duration, which lasts up to 54 weeks for each participant.

Researchers are evaluating the effectiveness of DT-101 in treating adults with Major Depressive Disorder (MDD). This Phase 2 clinical trial compares DT-101 to a placebo to understand its impact on depression symptoms and evaluates the safety and tolerability of the study drug. Participants have recurrent depression diagnosed by the latest DSM manual and are between 18 and 75 years old. Participants will receive either DT-101 or placebo in a double-blind, randomized manner. The study includes physical and neurological examinations, blood and urine sample collections, and clinical assessments to monitor ongoing suitability and gather data on the drug's effects. Blood samples will also be used to study how DT-101 is absorbed and metabolized and to explore genetic factors that may influence treatment response. During the study, participants will visit the clinic every few weeks to undergo general health checks and complete questionnaires. Researchers will measure changes in depression using the Montgomery Åsberg Depression Rating Scale (MADRS) from the start of the study to Day 42. Safety and adherence will be closely monitored throughout the trial, ensuring participant well-being and data accuracy.

Researchers are evaluating the safety and effectiveness of adding KarXT (Xanomeline/Trospium Chloride) to standard treatment for mania in adults with Bipolar-I Disorder. This Phase 3, randomized, double-blind study focuses on individuals experiencing acute manic episodes, with or without mixed features, who are already taking lithium, valproate, or lamotrigine. The study aims to measure changes in mania symptoms using the Young Mania Rating Scale at Week 5. Participants will be randomly assigned to receive either KarXT or a placebo alongside their stable dose of lithium, valproate, or lamotrigine. The doses of these medications are specified and given on set days during the study. Only those with stable mood stabilizer doses for at least two weeks prior to screening, and valproate treatment for at least seven months, are eligible. The treatment period lasts for 5 weeks. During the study, participants will be closely monitored through psychiatric evaluations and clinical assessments. Researchers will assess mania severity, safety, and any side effects. The main outcome is the change from baseline in the Young Mania Rating Scale score at Week 5. Participants’ physical health, including liver function and risk of urinary or gastrointestinal issues, will also be monitored to ensure safety throughout the trial.

Researchers are investigating the safety and effectiveness of KarXT in treating manic episodes in adults with Bipolar-I Disorder. This Phase 3 study focuses on individuals experiencing acute mania or mania with mixed features who require hospitalization. The study aims to compare KarXT with a placebo to see how well it reduces manic symptoms during a three-week inpatient period. Participants will be randomly assigned to receive either KarXT or a placebo at specified doses during the inpatient treatment phase. The study is double-blind, so neither the participants nor the researchers know who receives which treatment. The total study duration, including screening, treatment, and safety follow-up, will not exceed seven weeks. During the study, participants will be closely monitored through psychiatric evaluations and rating scales, including the Young Mania Rating Scale (YMRS) to measure changes in mania symptoms by week 3. Other assessments include the Clinical Global Impressions-Bipolar scale and safety evaluations. Researchers will track adherence, symptoms, and any side effects throughout the study period.

This trial investigates the efficacy and safety of SEP-363856 (Ulotaront) in adults aged 18 to 65 experiencing acute psychotic episodes related to schizophrenia. It is a Phase 3, randomized, double-blind, placebo-controlled, and multicenter study designed to evaluate treatment effects in participants undergoing symptom relapse or exacerbation within two months before screening. The study focuses on individuals requiring hospitalization for these symptoms and assesses changes in psychosis severity. Participants are randomly assigned to receive either SEP-363856 tablets or placebo tablets during the treatment period. The study design includes parallel groups to compare outcomes between the investigational drug and placebo. Treatment duration and dosing details are consistent with the study protocol but are not specified in this summary. Throughout the study, researchers monitor participants using the Positive And Negative Syndrome Scale (PANSS) to measure changes in symptom severity from baseline to Week 6. Additional assessments include Clinical Global Impression-Severity (CGI-S) scores and safety evaluations. The total study period includes screening, treatment, and follow-up to ensure comprehensive monitoring of efficacy and safety in acutely psychotic individuals with schizophrenia.

Researchers are evaluating the safety and effectiveness of LB-102, a drug called N-methyl amisulpride, in adults with Bipolar I Disorder who are currently experiencing a major depressive episode. This Phase 2 study is randomized, double-blind, placebo-controlled, and conducted at multiple centers. Participants must have a confirmed diagnosis of Bipolar I Disorder with a current major depressive episode lasting at least 4 weeks but no more than 18 months. Participants will be randomly assigned to receive either LB-102 or a placebo once daily by mouth for 6 weeks. The study compares the effects of the active drug against an inactive substance that looks identical. The treatment period lasts for the full 6 weeks, with no additional extension phases described. During the study, participants will undergo assessments including symptom rating scales like the Montgomery Åsberg Depression Rating Scale (MADRS-10) to measure changes in depression symptoms from the start to day 42. Other evaluations include clinical global impressions, mood rating scales, and physical health checks. Safety monitoring will occur throughout the 6-week treatment period to track any side effects or health changes.

Researchers are evaluating the safety and effectiveness of Brilaroxazine (RP5063), a new investigational drug, in adults aged 18 to 65 with acute schizophrenia. The study compares Brilaroxazine to a placebo over both short-term and long-term periods. It is designed as a phase 3, randomized, double-blind, placebo-controlled trial followed by an open-label extension to assess continued safety and efficacy. Participants receive fixed daily doses of Brilaroxazine at either 15 mg or 50 mg for 28 days during the double-blind phase. After this, the study continues with a 52-week open-label phase where doses can be adjusted flexibly between 15 mg and 50 mg daily. This long-term phase includes both participants who completed the initial placebo-controlled treatment and new participants with stable schizophrenia. During the study, participants undergo regular assessments including safety and efficacy evaluations. Researchers monitor the effects of Brilaroxazine over the entire 56-week period, including the initial 4-week double-blind phase and the subsequent 52-week open-label treatment. The primary outcomes focus on safety and efficacy of the drug throughout both study periods.

Researchers are evaluating lumateperone as a treatment for adults diagnosed with bipolar I disorder experiencing manic episodes or manic episodes with mixed features, with or without psychotic symptoms. This phase 3, multicenter study is randomized, double-blind, and placebo-controlled, aiming to assess the efficacy and safety of lumateperone in this acute setting. The study has three phases: a screening period lasting up to one week to assess eligibility; a double-blind treatment period of three weeks during which participants are randomly assigned to receive either lumateperone 42 mg capsules or matching placebo capsules orally once daily; and a safety follow-up period of one week where all participants return to the clinic for safety evaluations. Participants will be involved in assessments including the Young Mania Rating Scale at week 3 to measure treatment effects. Eligibility evaluations, safety monitoring, and follow-up visits are conducted throughout the study. The total participation duration includes screening, treatment, and safety follow-up over approximately five weeks.