Chino

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 safety and effectiveness of KarXT in adults aged 55 to 90 who have mild to severe Alzheimer's Disease (AD) accompanied by moderate to severe psychosis related to AD. This phase 3 study aims to better understand how KarXT compares to a placebo in treating the psychotic symptoms associated with Alzheimer's Disease. Participants must have documented AD diagnosis and a history of psychotic symptoms lasting at least two months prior to starting the study. Participants will receive either KarXT or a placebo, with specified doses given on designated days. The study is designed as a randomized, double-blind, placebo-controlled trial with parallel groups to assess the treatment's effects. Details about dosing schedules and administration are planned but not specified here. During the study, researchers will measure changes from baseline in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score up to week 14 to evaluate the impact on psychosis symptoms. Participants will undergo brain imaging (MRI or CT) if not already done within the past five years to rule out other conditions, and safety monitoring including laboratory tests will be conducted. The total participation duration covers screening through at least 14 weeks of treatment and assessment.

Researchers are evaluating the safety and effectiveness of KarXT combined with KarX-EC as a treatment for psychosis linked to Alzheimer's disease. This Phase 3 clinical trial focuses on people aged 55 to 90 years diagnosed with Alzheimer's disease and experiencing psychotic symptoms, such as hallucinations and delusions. The study aims to understand how this treatment affects these neuropsychiatric symptoms over approximately 14 weeks. Participants will receive either KarXT plus KarX-EC or a matching placebo at specified doses on designated days. The study is double-blind and placebo-controlled, meaning neither the participants nor the researchers know who receives the active treatment or placebo during the trial. This parallel group design helps compare the treatment's impact against no active drug. During the study, participants will be monitored for changes in hallucinations and delusions using the Neuropsychiatric Inventory-Clinician scale up to about week 14. They will also undergo brain imaging review from recent MRI or CT scans to confirm eligibility and rule out other causes of dementia. Safety and efficacy will be carefully assessed throughout the trial period, ensuring close observation of any side effects or improvements.

This research aims to evaluate how effective valbenazine is in improving symptoms reported by both doctors and patients in adults with tardive dyskinesia (TD). The study focuses on people who either continue to have symptoms while on a VMAT2 inhibitor or after stopping such treatment. Participants include adults diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder who have had mild or greater TD for at least three months. Participants will take valbenazine capsules orally as the treatment being studied. The trial is an open-label Phase 4 study, meaning all participants receive valbenazine and both clinicians and patients will report on outcomes. It includes people who remain symptomatic while on deutetrabenazine or have stopped prior VMAT2 inhibitor treatment. The study does not mention a comparator group or placebo. During the study, researchers will measure changes in involuntary movements using the Abnormal Involuntary Movement Scale (AIMS) from the start to week 24. Participants will be assessed for both clinician- and patient-reported outcomes to understand symptom changes. Safety and symptom monitoring will occur throughout the 24-week period to observe the effects of valbenazine.

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 evaluating the effectiveness and safety of KarXT for treating schizophrenia in adolescents aged 13 to 17 years. This Phase 3 study focuses on adolescents who meet diagnostic criteria for schizophrenia and experience symptoms of psychosis. The study aims to better understand how KarXT may impact symptoms as measured by a standard schizophrenia rating scale. Participants will receive either KarXT or a matching placebo at specified doses on specific days. The study is randomized, double-blind, and placebo-controlled, meaning neither the participants nor the researchers know who receives the active drug or placebo during the trial. During the study, researchers will assess changes in schizophrenia symptoms using the Positive and Negative Syndrome Scale (PANSS) after 5 weeks of treatment. Participants will be monitored for safety and symptom changes throughout the study period. The goal is to gather detailed information about KarXT's impact on schizophrenia symptoms in this adolescent population.

Researchers are evaluating the effects of SPT-300 (GlyphAllo), a prodrug of allopregnanolone, in adults aged 18 to 65 years who have major depressive disorder (MDD), with or without anxious distress. This Phase 2 study is randomized, double-blind, placebo-controlled, and aims to assess the efficacy, safety, and tolerability of SPT-300 as a monotherapy treatment for MDD. Participants will receive either SPT-300 or a placebo and will be monitored over a 42-day treatment period. The study compares the impact of SPT-300 to placebo on depressive symptoms and any side effects experienced. The intervention is given as a drug treatment, and participants are randomly assigned to one of the two groups. Throughout the study, researchers will measure changes in depression severity using the Hamilton Depression Rating Scale-17 (HAM-D-17) total score from the start of the treatment to day 42. Participants will be assessed for safety and tolerability, and their adherence to treatment will be monitored. The study focuses on the depressive episode lasting between 4 weeks and 18 months, with careful screening to ensure participant eligibility and safety.

Researchers are assessing the long-term safety and tolerability of two treatments, KarXT and KarX-EC, for adolescents with schizophrenia and children and adolescents with irritability related to autism spectrum disorder. This Phase 3, multicenter, open-label study includes participants aged 5 to 17 years and aims to monitor how these treatments are tolerated over time in these specific populations. Participants receive KarXT or a combination of KarXT and KarX-EC at specified doses on designated days. The study includes adolescents aged 13 to 17 years with schizophrenia and children and adolescents aged 5 to 17 years with autism-related irritability. Treatment is administered openly, meaning both researchers and participants know the treatment being given. Throughout the study, researchers will evaluate participants for any treatment-emergent adverse events, adverse events of special interest, and serious adverse events for up to 54 weeks. Safety assessments include monitoring physical examinations, vital signs, and ECGs. Participants must have completed earlier related studies without safety concerns to join, and their health will be closely monitored during the study to ensure safety and tolerability.

Researchers are evaluating ACP-211 as a monotherapy treatment for adults aged 18 to 65 who have major depressive disorder (MDD) and have not responded adequately to antidepressant therapy, including those with treatment-resistant depression. This Phase 2 study aims to determine if ACP-211 is more effective than a placebo in reducing depression symptoms and to monitor any adverse events experienced by participants. Participants will be randomly assigned to receive either ACP-211 or a placebo. The treatment involves taking ACP-211 alone without other antidepressants. The study compares these two groups over a treatment period to assess the impact on depression symptoms. Throughout the study, participants will undergo assessments including the Montgomery-c5sberg Depression Rating Scale (MADRS) at baseline and Day 28 to measure changes in their depression severity. Safety and side effects will be closely monitored to evaluate the treatment's tolerability. The total duration of participation includes screening, treatment, and follow-up assessments to ensure comprehensive evaluation of ACP-211's effects.