Richardson

Researchers are evaluating the effectiveness and safety of brenipatide when given along with standard care compared to a placebo with standard care in adults with bipolar disorder. This Phase 2 study aims to see if brenipatide can delay the worsening of bipolar symptoms. The trial includes participants aged 18 to 75 years and involves a careful assessment of how well the treatment works and its safety profile. The trial has three main periods: a screening period lasting about one month, a treatment period of at least six months, and a follow-up period of around two months. Participants receive either brenipatide or placebo, both given by subcutaneous injection, alongside their usual bipolar disorder medications. The study may end earlier if symptoms worsen or if participants withdraw for any reason. Participants will be asked to self-inject the study medication, maintain diaries, complete questionnaires, and attend regular visits throughout the study. Researchers will monitor the time to relapse, defined as the number of days from randomization until symptoms worsen according to specific criteria, over at least six months. Safety and adherence to treatment will also be closely observed during the study.

Researchers are evaluating the safety and effectiveness of brenipatide compared to a placebo for adults with moderate-to-severe Alcohol Use Disorder (AUD). This phase 3 study aims to better understand if brenipatide can help reduce drinking in this population. Participants will be followed for about 56 weeks to gather comprehensive information. Participants will receive either brenipatide (LY3537031) or a placebo, both given by subcutaneous injection. The study involves a randomized, double-blind design, meaning neither the participants nor the researchers know who receives which treatment during the trial. This method helps provide reliable results about the effects and safety of brenipatide. During the study, participants will attend scheduled visits, self-inject the study drug, and complete electronic and paper diaries as well as questionnaires. Researchers will monitor changes in drinking patterns using the Timeline Followback Method for up to 56 weeks. Safety monitoring and regular assessments will be performed throughout the study to track participants' health and adherence.

Researchers are evaluating a combination of disitamab vedotin and tucatinib for treating patients with advanced or metastatic breast cancer or gastric cancer that express the HER2 protein. These solid tumors, which arise in organs like the breast or stomach, are challenging to treat once they have spread or grown larger. The trial focuses on patients whose tumors have HER2, a marker that can make the cancer grow and spread faster. The study aims to assess the safety and effectiveness of this drug combination in these cancers. The study includes a dose escalation phase where disitamab vedotin is given intravenously while tucatinib is taken orally twice daily at 300 mg. After determining two appropriate dose levels, the study proceeds to a dose optimization phase to evaluate safety and efficacy in different patient groups based on HER2 expression and cancer type. Following this, an expansion phase will test the treatment in four specific cohorts, including HER2-low and HER2-positive breast and gastric cancers. Participants will have regular assessments including monitoring for side effects, laboratory tests, and scans to evaluate tumor response using RECIST criteria. Safety will be followed for up to approximately five years after the last treatment dose. Key outcomes measured include the number of participants experiencing dose-limiting toxicities, adverse events, laboratory abnormalities, and dose changes. The study also tracks the objective response rate to the treatment over about three years.

This study will test the safety of a drug called PF-08046054/SGN-PDL1V alone and with pembrolizumab in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). This study will have five parts. Parts A and B of the study will find out how much PF-08046054/SGN- PDL1V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe PF-08046054/SGN-PDL1V is and if it works to treat solid tumor cancers. In Part D and E, participants will be given PF-08046054/SGN-PDL1V with pembrolizumab to find out how safe this combination is and if it works to treat solid tumor cancers.

Researchers are evaluating the effectiveness and safety of SP-624 compared to a placebo in adults aged 18 to 65 with moderate to severe Major Depressive Disorder (MDD). This Phase 2B study focuses on treating this condition and assesses changes in depression severity using the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to week 4. Participants receive either SP-624 or a placebo once daily. The SP-624 treatment consists of two capsules taken orally each day, providing a total dose of 20 mg. Those in the placebo group take two matching placebo capsules daily. The study is designed as a multi-center, double-blind, randomized, placebo-controlled trial. During the study, participants will be monitored for changes in depression severity through the MADRS assessment from the start of the study to week 4. Researchers will also evaluate safety and tolerability throughout the treatment period. The total study duration and specific follow-up details are not provided but include careful observation of participants' health and response to treatment.

Bipolar disorder is a serious, long-lasting mood disorder affecting adults and children in the United States. This study evaluates the safety and effectiveness of Icalcaprant, an investigational oral medication, in adults with bipolar I or II disorder who are experiencing depressive episodes. The trial is a Phase 2, double-blind, placebo-controlled study involving about 195 adult participants across approximately 35 U.S. sites. Participants are randomly assigned to one of three groups, including a placebo group, to receive oral capsules of either Icalcaprant or placebo once daily for 6 weeks. Following treatment, there is a 4-week safety follow-up period to monitor participants' health and any side effects. The study assesses changes in depression severity using the Montgomery-Åsberg Depression Rating Scale (MADRS) and tracks any adverse events during the approximately 10-week period. Throughout the trial, participants will visit clinics or hospitals regularly for medical assessments, blood tests, and questionnaires to monitor their condition, side effects, and overall health. Researchers will measure the change in depression symptoms from baseline to Week 6 and record any adverse events up to about 10 weeks. Participants' treatment adherence and safety are closely observed during the study and follow-up periods.

Schizophrenia is a serious psychiatric disorder that affects thinking, language, perception, and the sense of self. This research aims to evaluate the safety, side effects, effects on disease symptoms, and how the investigational drug emraclidine is processed in adults with schizophrenia. The study is a Phase 2 clinical trial involving about 268 participants across approximately 32 sites in the United States. Participants are divided into two groups: Part A and Part B. In Part A, participants receive varying doses of oral emraclidine or placebo for 14 to 21 days. In Part B, participants receive oral emraclidine or placebo for up to 42 days. After completing the treatment, all participants are followed for 30 days to monitor safety and effects after stopping the drug. During the study, participants will attend regular hospital or clinic visits for medical exams, blood tests, questionnaires, and monitoring for side effects. Researchers will measure multiple outcomes including adverse events, changes in schizophrenia symptoms using the Positive and Negative Syndrome Scale (PANSS), and how the drug and its metabolites move through the body. The total participation time includes treatment and a 30-day follow-up period.

Major depressive disorder (MDD) is a common and serious mood disorder causing persistent sadness and loss of interest, along with emotional and physical symptoms like irritability, tiredness, and changes in appetite. This trial investigates the effects of oral Icalcaprant, an experimental drug, on adults currently experiencing a major depressive episode. The study aims to assess changes in disease activity and monitor adverse events over the treatment period. Participants will be randomly assigned to one of three groups, with about one-third receiving a placebo. Those in the treatment arms will take oral capsules of Icalcaprant once daily for six weeks. After the treatment period, there will be a 30-day safety follow-up to monitor any ongoing effects or side effects. During the study, participants will visit the hospital or clinic regularly for medical assessments, blood tests, side effect monitoring, and to complete questionnaires. Researchers will evaluate changes in depression severity using the Montgomery-Åsberg Depression Rating Scale (MADRS) and track the number of participants experiencing adverse events. The total participation duration includes the six-week treatment and the 30-day follow-up.

Researchers are conducting a Phase 2, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of the oral drug ML-007C-MA in adult inpatients aged 18 to 64 years who have schizophrenia and are experiencing a sudden worsening of psychosis. The study aims to compare ML-007C-MA to a placebo in treating symptoms of schizophrenia that are not well controlled, with effectiveness measured by changes in the Positive and Negative Syndrome Scale (PANSS) total score. Participants will be assigned to one of three groups: one receiving ML-007C-MA twice daily at a dose of 210/3 mg, another receiving ML-007C-MA once daily at 330/6 mg, and a third group receiving a matched placebo. The treatment period lasts 5 weeks, during which participants remain in an inpatient setting. The study is designed to maintain blinding and closely monitor participants' response to the treatments. Throughout the study, participants will undergo evaluations at the start and end of treatment, including assessments using the PANSS to measure schizophrenia symptoms. Researchers will monitor safety, tolerability, and any side effects while participants remain hospitalized and under observation for the full study duration. The main measure of success is the change in PANSS total score from baseline to the end of treatment after 5 weeks.

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.