Gaithersburg

Researchers are evaluating the long-term safety and tolerability of LB-102 in adults with stable schizophrenia who have had inadequate responses, side effects, or issues with their current antipsychotic medications, or who have completed prior LB-102 studies. This Phase 3, open-label, multicenter trial focuses on patients aged 18 to 65 years with stable disease and aims to provide extended monitoring of this treatment. Participants will receive LB-102 with flexible dosing ranging from 50 mg to 100 mg. This single-group study involves administering the drug openly over 52 weeks to assess how well patients tolerate it and to monitor safety during this period. Throughout the study, participants will undergo evaluations including monitoring adverse events and treatment-emergent events. Effectiveness will be assessed using the Positive and Negative Syndrome Scale PANSS. The study lasts up to 52 weeks, during which safety and tolerability are carefully observed and recorded.

Researchers are evaluating the safety and effectiveness of KarXT combined with KarX-EC in adults aged 55 to 90 who have agitation related to Alzheimers Disease. This Phase 3, randomized, double-blind, placebo-controlled study aims to address agitation symptoms in this population by comparing the investigational drugs with a placebo. The study is sponsored by Bristol-Myers Squibb and uses established diagnostic criteria for Alzheimers Disease. Participants will receive either the combination of XanomelineTrospium Chloride capsules KarXT KarX-EC or a placebo with specified doses on designated days. The study includes a parallel group design and treatment lasts for 14 weeks. The main focus is to assess changes in agitation using the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association CMAI-IPA total score. During the study, participants will undergo regular assessments including cognitive and behavioral evaluations, safety monitoring through vital signs, laboratory tests, electrocardiograms, and rating scales for movement disorders and suicidal ideation. Caregivers will be involved to help monitor participant status and medication compliance. The primary outcome is measured at Week 14, with safety follow-up extending to Week 18. Participants are expected to be engaged throughout the treatment period and follow-up assessments.

Researchers are evaluating the efficacy and safety of brenipatide combined with standard of care compared to placebo plus standard of care in delaying the worsening of symptoms in adults with bipolar disorder. This Phase 2, randomized, double-blind study aims to understand if brenipatide can help delay relapse in bipolar disorder patients. The study is sponsored by Eli Lilly and Company and focuses on adults aged 18 to 75 years diagnosed with bipolar disorder I or II. Participants will be randomly assigned to receive one of two doses of brenipatide or a placebo, each administered by subcutaneous injection alongside their standard of care medication. The trial is divided into three periods a screening period lasting about one month, a treatment period lasting at least six months, and a follow-up period lasting approximately two months. The total duration of participation may vary and can be shortened if symptoms worsen or if the participant withdraws. During the study, participants will self-inject the study medication, maintain study diaries, and complete questionnaires assessing their condition. Researchers will monitor time to relapse, changes in functional impairment, mood symptoms using specific rating scales, quality of life, patient global impressions, body weight, and pharmacokinetics. Safety will be closely observed, including the presence of treatment-emergent anti-drug antibodies. Participants are expected to attend regular visits throughout the treatment and follow-up periods.

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 studying the investigational drug LTX-001 to determine its safety and tolerability in adults diagnosed with schizophrenia who are experiencing a recent worsening of symptoms, known as an acute exacerbation. This early-phase trial also examines how the drug behaves in the body over time, how it affects schizophrenia symptoms, and changes in certain blood markers after taking LTX-001. Participants will be randomly assigned to receive different doses of LTX-001 or a placebo to compare effects. Eligible participants will stay overnight in a research unit for about five weeks, or up to 49 nights if they require up to 14 days to stop current antipsychotic medications before starting the study drug. They will take LTX-001 or placebo orally once or twice daily depending on the assigned dose. During the trial, participants will visit the study site three times for assessments including medical history review, physical and neurological exams, heart monitoring, blood and urine tests, psychiatric evaluations, and eye exams. Throughout the study and until Day 42, researchers will monitor participants for safety by tracking adverse events, lab tests, vital signs, heart activity, neurological exams, and suicidality risk. They will also assess drug levels in the body on specific days. After the treatment period, participants return for a follow-up visit one week later. Assessments include symptom scales, cognitive tests, and detailed psychiatric and physical evaluations to understand the drugs effects and safety profile.

Schizophrenia is a serious psychiatric illness marked by significant disturbances in thinking, language, perception, and self-awareness. Researchers are evaluating the safety, effects on disease activity, and how the investigational drug emraclidine is processed in the body in adults with schizophrenia. This is a Phase 2 study designed to explore these aspects with careful monitoring. Participants are divided into two parts. In Part A, participants receive different increasing 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. Following treatment, all participants enter a 30-day safety follow-up to monitor any lasting effects. During the study, participants will attend regular clinic visits for medical exams, blood tests, and questionnaires to check for side effects and disease changes. Researchers will measure adverse events, drug levels in the blood, and changes in schizophrenia symptoms using specific scales. The total participation time may be up to about 74 days including treatment and follow-up.

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 efficacy, safety, and pharmacological effects of three different doses of KYN-5356 compared to a placebo in adults with cognitive impairment associated with schizophrenia. This Phase 2, randomized, double-blind, placebo-controlled study aims to investigate how these treatments affect cognitive function and brain activity. The study assesses pharmacokinetics and exploratory pharmacodynamics to understand how the drug behaves and impacts neurophysiological measures in the brain. Participants will be randomly assigned to one of four groups receiving either low, medium, or high doses of KYN-5356 or a placebo. Treatment involves taking oral tablets daily for 28 days while residing in the clinic. Participants are admitted three days before treatment begins and remain in the clinic for 32 days. Electrophysiological tests will be performed on a subset of participants to evaluate the drugs effect on brain function. During the study, participants will undergo frequent evaluations for efficacy, safety, and drug levels in the body. Safety assessments continue until discharge on Day 29, followed by a follow-up visit on Day 42. Researchers will measure cognitive function changes and monitor pharmacokinetic parameters such as maximum concentration and half-life. The total participation period includes the 32-day residential stay plus the follow-up visit, allowing close monitoring throughout.

Researchers are evaluating the effect of DT-101 compared to placebo in adults with Major Depressive Disorder MDD. This Phase 2 clinical trial aims to assess the safety, tolerability, and impact of DT-101 on depression symptoms in adults aged 18 to 75 years who have recurrent depression diagnosed by DSM 5-TR. The study is randomized, double-blind, and placebo-controlled, focusing on treatment for this condition. Participants will be assigned to one of three groups two experimental groups receiving different formulations of DT-101 DT-101 A or DT-101 B or a placebo group. The study involves regular clinic visits every couple of weeks where the study drug or placebo is administered and ongoing assessments are conducted. Blood and urine samples will be collected to monitor the drugs absorption and use in the body, including optional genetic testing to explore responses to DT-101. During the study, participants will undergo physical and neurological exams, clinical assessments, and complete questionnaires about their health and depression symptoms. The primary outcome measure is the change in depression severity using the Montgomery sberg Depression Rating Scale MADRS over 42 days. Safety and tolerability will be monitored throughout. Participation involves multiple visits for health checks and data collection until the study concludes in August 2027.

Researchers are evaluating the effects of KarXT for treating manic episodes in adults with Bipolar-I disorder. This Phase 3, randomized, double-blind, placebo-controlled study aims to assess KarXTs ability to reduce mania symptoms during a 3-week inpatient treatment period. The study includes participants experiencing acute manic episodes or mania with mixed features who require hospitalization. Participants will receive either KarXT or a placebo with flexible dosing during the 3-week inpatient treatment. Before treatment, psychotropic medications must be washed out within 14 days. The study also includes screening before treatment and a safety follow-up, with the entire study lasting up to seven weeks. During the study, participants will be closely monitored with assessments including the Young Mania Rating Scale YMRS and Clinical Global Impressions-Bipolar CGI-BP to measure symptom changes. Safety evaluations and follow-up visits are part of the process, with researchers focusing on symptom improvement and safety over the study duration.