Lemon Grove

Researchers are evaluating the long-term safety, tolerability, and effectiveness of ML-007C-MA in adults with schizophrenia. This Phase 2, open-label study lasts 52 weeks and includes participants who have recently completed a previous study or are enrolling directly. The study focuses on those diagnosed with schizophrenia according to DSM-5 criteria and aims to understand the impact of extended use of ML-007C-MA. Participants receive ML-007C-MA dosed at 210/3 mg twice daily throughout the 52-week treatment period. This study involves continuous administration of the drug to monitor its effects over a long duration. No comparator group is mentioned, as all participants receive the investigational treatment in an open-label design. During the study, participants will undergo regular assessments to monitor safety, tolerability, and effectiveness. Researchers will evaluate clinical interviews, physical examinations, ECGs, laboratory tests, and informant reports. Outcome measures focus on safety through the treatment course and up to the end of the study. Participants may be followed closely for up to one year, with assessments to detect any adverse effects or changes in condition.

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.

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 effects of KYN-5356 on cognitive function in adults with cognitive impairment associated with schizophrenia. This Phase 2 study is randomized, double-blind, and placebo-controlled, designed to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of three different dose levels of KYN-5356 compared to placebo over 28 days. Participants are assigned to one of four groups: placebo, low dose KYN-5356, medium dose KYN-5356, or high dose KYN-5356. The study involves oral tablet administration once daily from Day 1 through Day 28. Participants are admitted to the clinic three days before treatment begins and remain in residence for 32 days. Some participants at selected sites will undergo special brain function tests to study the neurophysiological effects of KYN-5356. During the study, participants will have ongoing assessments for efficacy, safety, and drug behavior in the body. They will be discharged on Day 29 after safety checks and return for a follow-up visit on Day 42. Researchers will measure cognitive function as the primary outcome to determine the impact of the treatment over the 28-day 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 studying Benfotiamine, a drug that might delay or slow the symptoms of early Alzheimer's disease. This clinical trial is a randomized, double-blind, placebo-controlled study lasting 18 months, designed with a seamless phase 2A-2B approach involving 406 participants. The goal is to learn about the safety, effectiveness, and tolerability of Benfotiamine in people with early Alzheimer's disease. In phase 2A, about 150 participants will be randomly assigned to receive either 1200 mg/day Benfotiamine, 600 mg/day Benfotiamine, or a placebo. This phase aims to find the highest dose that is safe and well tolerated by measuring tolerability events up to 72 weeks. In phase 2B, all participants who received Benfotiamine will continue at the selected dose, and the study will evaluate the drug’s effect on cognitive function and daily living abilities over 72 weeks, while also monitoring longer-term safety and tolerability. Participants will attend clinic visits where cognitive and functional assessments will be done, including the Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 and Clinical Dementia Rating - Sum of Boxes. Blood tests for biomarkers and other safety monitoring will be conducted throughout the study. Participants will be followed for up to 72 weeks to assess changes in cognition, function, and tolerability of the treatment.

Researchers are evaluating the long-term safety and tolerability of adjunctive KarXT, a combination of xanomeline and trospium chloride, in adults aged 18 to 65 with schizophrenia who did not have sufficient symptom control with their current antipsychotic medications. This Phase 3, open-label extension study involves participants who previously completed the treatment period of the ARISE study (KAR-012). The goal is to monitor how well patients tolerate KarXT over an extended period while assessing related safety concerns. Participants receive fixed doses of KarXT capsules twice daily, with doses ranging from 50 mg/20 mg up to 125 mg/30 mg. The study lasts for 52 weeks as an outpatient program. This open-label extension allows researchers to observe the effects and safety of KarXT when added to stable antipsychotic treatment under real-world conditions. During the study, researchers closely monitor participants for any treatment-emergent adverse events from the initial dose through a safety follow-up visit at 54 weeks or early termination. Participants will undergo regular assessments, including clinical evaluations and reports from reliable caregivers who assist with study activities. The study ensures participants maintain stable living situations and continue their background antipsychotic medications throughout the study period.

Researchers are studying adults aged 18 to 70 who have a prescription for methadone for chronic pain, aiming to develop a minimally invasive wearable Remote Medication Monitor (RMM). This device would provide continuous, real-time data on methadone levels in interstitial fluid (ISF) to help verify if a prescribed dose has been taken. The study focuses on methadone toxicity, overdose, and issues related to poor drug metabolism. The study involves two main parts. In the first, researchers will measure methadone and its metabolites in ISF and blood samples collected over up to six consecutive hours using laboratory methods like Liquid Chromatography-Mass Spectroscopy (LC-MS). In the second, participants will wear an intradermal microneedle sensor that continuously monitors methadone levels in the ISF over six hours to generate a dosing curve display. Participants will attend two separate visits to complete these parts. During the study, participants will provide biosamples such as blood and ISF for pharmacokinetic monitoring. Assessments include measuring methadone concentrations before and after doses, comparing different testing methods, and analyzing correlations between ISF and blood levels. Researchers will track medication adherence and safety throughout the study, which involves up to 20 adult participants. The total monitoring time for each visit is about six hours.

Researchers are assessing the effectiveness of NBI-1117568 compared to a placebo in preventing relapse of schizophrenia symptoms in adults. This Phase 3 study focuses on individuals who have shown a stable response after initial open-label treatment with NBI-1117568. The study aims to determine how well NBI-1117568 delays the return of symptoms in this population. Participants receive either oral capsules of NBI-1117568 or a matching placebo in a double-blind, randomized withdrawal design. The treatment phase follows the open-label period where all participants initially receive NBI-1117568. This setup allows comparison of relapse times between those continuing the drug and those switched to placebo. Throughout the study, researchers monitor the time from randomization to symptom relapse for up to about 30 weeks. Participants undergo psychiatric evaluations and safety assessments to track tolerability and any adverse effects. The study includes adults aged 18 to 65 with stable schizophrenia who have responded to prior antipsychotic therapy, and it aims to provide detailed information on the safety and efficacy of NBI-1117568 over the treatment period.