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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 azetukalner as a treatment for adults diagnosed with moderate-to-severe Major Depressive Disorder MDD. This Phase 3, randomized, double-blind, placebo-controlled study aims to assess the clinical efficacy, safety, and tolerability of azetukalner when taken alone. The study involves participants aged 18 to 74 who have experienced their first major depressive episode before age 50. Participants receive either azetukalner 20 mg or a placebo orally once a day with food, preferably with the evening meal, for a total of 6 weeks. The study includes two groups one taking azetukalner and the other taking placebo, both under blinded conditions to ensure unbiased results. During the study, participants will be regularly monitored through clinical evaluations, including changes in depression severity scores such as the Hamilton Depression Rating Scale HAMD-17 and other scales measuring pleasure and clinical global impression. Safety and tolerability will be observed from screening through 8 weeks after the final dose. The total study duration includes screening, 6 weeks of treatment, and post-treatment safety follow-up.

This trial enrolls participants from previous studies evaluating adagrasib either alone or combined with other cancer therapies in patients with non-small cell lung cancer, colorectal cancer, and other advanced solid tumors. It is an open-label continuation study designed to provide long-term treatment for cancer patients who have already participated in those parent trials. The study is sponsored by Mirati Therapeutics Inc. and focuses on treatment of solid tumors. Participants receive adagrasib and may also receive other cancer drugs such as pembrolizumab, cetuximab, pemetrexed, docetaxel, irinotecan, leucovorin, oxaliplatin, and fluorouracil. The dosing and schedule are specified but depend on the parent study protocols. This trial includes multiple experimental arms reflecting different treatment combinations or regimens, continuing treatment for eligible patients who showed clinical benefit in the parent studies. During the study, participants are monitored for adverse events up to 90 days after their last dose or if they discontinue treatment. Researchers track serious adverse events, treatment-related discontinuations, and deaths related to adverse events. Participation involves ongoing treatment and safety assessments, with the study lasting until the primary completion date in February 2028. The study does not include healthy volunteers and involves adults aged 18 years and older.

Researchers are evaluating the effectiveness and safety of brenipatide combined with standard care compared to a placebo plus standard care for treating schizophrenia in adults aged 18 to 55. This phase 2 clinical trial aims to better understand how brenipatide works alongside existing treatments in this population. Participants are randomly assigned to receive either brenipatide or placebo, both administered by subcutaneous injection, alongside their usual standard of care medications. The study includes a screening period lasting about one month, followed by a treatment period that can last up to 12 months, and then a follow-up period of approximately two months. During the trial, participants will attend scheduled visits to monitor their health, complete questionnaires, and maintain diaries about their medication use. Researchers will measure changes in body weight, neurocognitive function, schizophrenia symptom severity, and other clinical assessments. Safety is closely monitored throughout, and the total participation time may last up to about 15 months.

Researchers are evaluating disitamab vedotin alone or combined with pembrolizumab to treat urothelial cancer that expresses HER2. This study focuses on participants with locally advanced or metastatic urothelial cancer that cannot be removed by surgery. It aims to assess how well the drug works and to monitor the side effects experienced by participants. Participants receive disitamab vedotin intravenously every 2 weeks, either alone or with pembrolizumab given by intravenous infusion on Day 1 of each 6-week cycle. The study includes multiple cohorts receiving different combinations or monotherapy treatments. The treatment period and monitoring last approximately 2 years, with ongoing assessments of drug effects and safety. During the study, participants undergo regular evaluations including imaging scans to measure tumor response, laboratory tests, electrocardiograms to monitor heart function, and assessments of side effects. Researchers measure treatment response using established cancer evaluation criteria and track survival and disease control over about 3 years. Participants are closely monitored for adverse effects and blood levels of the drugs to understand how the treatments behave in the body.

Researchers are evaluating the study drug JNJ-42847922, also called seltorexant, in adults and older adults with major depressive disorder MDD, a mood disorder causing lasting sadness and loss of interest. The study aims to compare seltorexant with a placebo in improving depressive symptoms during a double-blind treatment phase and to assess the long-term safety and tolerability of seltorexant in an open-label phase. Participants will receive either seltorexant or a matching placebo tablet once daily for 42 days during the double-blind phase. Those who qualify for the open-label phase will then take seltorexant daily for up to six months. The treatments are oral tablets, and the study includes two main periods the initial 42-day double-blind phase and the subsequent long-term open-label phase. During the study, participants will have regular assessments including physical exams, vital signs, ECGs, and questionnaires on depression, sleep disturbance, suicidality, withdrawal symptoms, sexual functioning, body measurements, and laboratory tests. Researchers will measure changes in depression scores and monitor adverse events and safety indicators throughout both phases. The total participation can last up to about seven months including both treatment periods.

Researchers are evaluating whether combining tucatinib with trastuzumab and mFOLFOX6 works better than standard treatments for people with HER2 positive colorectal cancer that has spread or cannot be removed by surgery. This Phase 3 study also aims to learn about the side effects that may occur when taking this combination of drugs. Participants have metastatic or unresectable colorectal cancer and are randomly assigned to different treatment groups. Participants are randomly placed in one of two study groups. One group receives tucatinib taken orally twice daily along with trastuzumab given intravenously every 3 weeks and mFOLFOX6 chemotherapy every 2 weeks. The other group receives standard care, which may be mFOLFOX6 alone or combined with bevacizumab or cetuximab, both given intravenously on different schedules. Tissue samples and biopsies are collected before treatment to confirm HER2 positivity and other markers. During the study, participants will have regular evaluations including imaging scans to measure cancer progression, blood tests, and assessments of side effects and quality of life. Progression-free survival is the primary outcome measured for up to about 3 years, with other outcomes like overall survival and response rate also tracked. Safety monitoring continues for about one year after the last treatment. The study lasts several years, with ongoing follow-up to understand long-term effects and benefits.

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.

Researchers are evaluating the combination of nivolumab and blinatumomab compared to blinatumomab alone in children and young adults aged 1 to under 31 years with first relapse of CD19 B-cell acute lymphoblastic leukemia B-ALL, including patients with Down syndrome. This phase II trial aims to compare event-free survival after reinduction and consolidation therapy, assess safety and tolerability, and explore various outcomes such as remission rates and toxicity, with follow-up up to 10 years after enrollment. Participants receive treatments based on their assigned groups and arms, involving cycles of immunotherapy including blinatumomab, nivolumab, dexamethasone, methotrexate, and other chemotherapy drugs given by various routes such as intravenous infusion, intrathecal injection, and oral administration. Treatment cycles repeat every 36 or 37 days for up to two cycles, with some groups receiving radiation therapy or maintenance chemotherapy afterward. Patients with high white blood cell counts or specific disease locations may receive pre-immunotherapy treatments. Throughout the study, participants undergo lumbar punctures, bone marrow biopsies and aspirations, and collection of blood, urine, and cerebrospinal fluid for monitoring. Researchers measure outcomes such as minimal residual disease negative remission rates and event-free survival. After completing treatment, participants are followed every three months for one year to monitor their health and any long-term treatment effects.

Researchers are studying the effects of KarXT on bladder function and urological safety in adults diagnosed with schizophrenia according to DSM-5 criteria. This phase 4, open-label study aims to understand how KarXT influences urinary flow rates and residual urine volume over a 12-month period. The study is sponsored by Bristol-Myers Squibb and focuses on safety monitoring for participants with schizophrenia. Participants will receive KarXT, which consists of xanomeline and trospium chloride, administered at specified doses on designated days. The study lasts for 12 months, during which participants will be observed for changes in their urinary function and safety parameters related to the medication. No placebo or comparison group is mentioned, and the study is open-label, meaning both researchers and participants know the treatment being given. During the study, participants will undergo regular assessments including measurements of urinary flow and residual volume, urinalysis, symptom questionnaires, electrocardiograms, vital sign checks, and monitoring for adverse events including serious and special interest events. Researchers will also track any changes in suicidal thoughts or behaviors. The total participation duration is up to 12 months with ongoing safety and efficacy evaluations throughout this period.