Lemon Grove

Researchers are conducting a 52-week open-label study to evaluate the long-term safety, tolerability, and effectiveness of ML-007C-MA in adults with schizophrenia. This study includes participants who have recently completed a prior study ML-007C-MA-211 as well as new participants enrolling directly. The goal is to better understand how ML-007C-MA performs over an extended period in managing schizophrenia symptoms. Participants will receive ML-007C-MA dosed as 2103 mg twice daily throughout the 52-week treatment period. The study is designed as an open-label trial, meaning both researchers and participants know the treatment being administered. No placebo or comparator groups are involved in this phase 2 research. During the study, participants will undergo assessments to monitor safety and tolerability from the initial dose through the end of treatment. Researchers will also evaluate the effectiveness of ML-007C-MA in managing schizophrenia symptoms. The study involves outpatient care, regular clinical interviews, and the involvement of reliable informants to support assessments. Participants will be observed for up to one year to gather comprehensive data on long-term treatment outcomes.

Major depressive disorder MDD is a mood disorder causing ongoing sadness and loss of interest, with emotional and physical symptoms such as irritability, difficulty focusing, tiredness, and changes in eating habits. Researchers are studying oral Icalcaprant, an investigational drug, to assess its effects on disease activity and side effects in adults currently experiencing a major depressive episode. Participants are randomly assigned to one of three groups two different doses of Icalcaprant or a placebo. They will take oral capsules once daily for 6 weeks, followed by a 30-day safety follow-up period. The study is conducted at about 35 sites across North America and involves approximately 195 adults. During the study, participants will attend regular visits at a hospital or clinic where medical assessments, blood tests, side effect checks, and questionnaires will be completed. Researchers will measure changes in depression severity using scales like the Montgomery-sberg Depression Rating Scale MADRS over about 6 weeks, and adverse events will be monitored for up to 10 weeks total.

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 studying the effects of a drug called TNX-102 SL on adults with moderate to severe major depressive disorder MDD. This clinical trial aims to find out if TNX-102 SL improves depression symptoms compared to a placebo and to assess its safety. The study focuses on changes in depression symptoms measured by a rating scale over six weeks. Participants will take either 5.6 mg of TNX-102 SL two 2.8 mg tablets or placebo tablets every night at bedtime for six weeks. The study is randomized and double-blind, meaning neither participants nor researchers know who receives the drug or placebo. Checkups and tests will take place at the clinic every two weeks during the treatment period. During the trial, participants will have depression symptom assessments and other evaluations to monitor safety and treatment effects. The main measurement is the change in depression rating scores from the start to week six. Participants will be closely followed throughout the six-week treatment, with regular visits every two weeks for monitoring and questionnaires.

Researchers are evaluating the effectiveness and safety of the drug SEP-363856 in adults experiencing acute psychotic episodes related to schizophrenia. This Phase 3 clinical trial uses a randomized, double-blind, placebo-controlled design to compare SEP-363856 against placebo in a parallel-group multicenter setting. The study focuses on participants aged 18 to 65 who are experiencing a recent worsening of schizophrenia symptoms. Participants are assigned to one of three groups receiving either a placebo, 75 mgday of SEP-363856, or 100 mgday of SEP-363856 tablets. The study treatment is given daily, and the trial lasts for six weeks. During this time, efficacy and safety data are collected to assess the impact of SEP-363856 on schizophrenia symptoms. Throughout the study, participants undergo regular assessments including the Positive and Negative Syndrome Scale PANSS and the Clinical Global Impression-Severity CGI-S scale to measure symptom changes from baseline to week 6. Safety is monitored as part of the trial. Participants are followed until the end of the six-week treatment period, with all study visits and procedures conducted during this timeframe.

Researchers are conducting a pilot observational study to develop a minimally invasive wearable Remote Medication Monitor RMM that continuously and in real time measures methadone levels in the interstitial fluid ISF. This study aims to evaluate whether such a device can monitor medication adherence by showing if prescribed methadone doses have been taken. The study involves adults aged 18 to 70 who are prescribed methadone for chronic pain. The study consists of multiple aims involving biosample collection and pharmacokinetic monitoring. In Aim 1, biosamples of ISF and blood will be collected over up to 6 hours to assess if the RMM can detect methadone dose timing using ex vivo methods. Aim 2 involves inserting intradermal microneedle sensors into the skin to continuously monitor methadone levels via the RMM over 6 hours. Later aims include longer monitoring periods of up to 3 days to observe methadone and its metabolites in ISF. Participants will attend up to three visits involving ISF and blood sample collections, wearing the RMM device, and pharmacokinetic monitoring. Researchers will analyze methadone concentrations and metabolite levels using advanced laboratory techniques such as Liquid Chromatography-Mass Spectroscopy. The primary outcomes include correlations between methadone measurements in ISF and blood to evaluate the devices monitoring capabilities. The study is expected to run until April 2026.

Researchers are evaluating the drug NBI-1117568 in adults with schizophrenia to see if it can delay the return of symptoms after a stable response to initial treatment. This phase 3 study compares NBI-1117568 with a placebo in a randomized, double-blind format to assess both its effectiveness and safety. The trial is sponsored by Neurocrine Biosciences and focuses on adults aged 18 to 65 years who have been diagnosed with schizophrenia for at least one year and have previously responded to antipsychotic therapy other than clozapine. All participants first receive NBI-1117568 during an open-label stabilization period to achieve symptom control. After this, participants are randomly assigned to continue with either NBI-1117568 or a placebo during the double-blind treatment period, which lasts up to approximately 30 weeks. Both treatments are given as oral capsules, and the study uses a quadruple-blind design to ensure unbiased results. Participants will be closely monitored throughout the study for symptom relapse, with the primary outcome measuring the time from randomization to relapse. Assessments include psychiatric evaluations and safety checks to monitor tolerability of the drug. The total participation duration includes the stabilization phase and the double-blind treatment period, providing detailed information on the drugs ability to maintain symptom stability in schizophrenia over time.

Researchers are evaluating the efficacy and safety of milsaperidone as an additional treatment for patients with Major Depressive Disorder MDD who have not responded adequately to antidepressant therapy. This Phase 3, randomized, double-blind, placebo-controlled study aims to compare milsaperidone with a placebo to better understand its potential benefits and risks in this population. The study involves two groups one receiving oral milsaperidone and the other receiving an oral placebo. Participants will be randomly assigned to one of these groups, and neither they nor the researchers will know which treatment is given during the study. This design helps ensure unbiased results about how milsaperidone performs as an add-on therapy compared to placebo. Participants will be involved in the study for at least six weeks, during which their depression symptoms will be assessed using the Montgomery-Asberg Depression Rating Scale MADRS to measure changes from baseline. The study will monitor safety and effectiveness closely throughout this period. The trial is sponsored by Vanda Pharmaceuticals and is expected to run until March 2028.

Researchers are evaluating the efficacy and safety of LB-102 in treating adult patients with Bipolar I Disorder who are currently experiencing a major depressive episode. This Phase 2, randomized, double-blind, placebo-controlled multicenter study aims to compare the effects of LB-102 against a placebo over a treatment period of six weeks. Participants will be randomly assigned in equal numbers to receive either LB-102 or a placebo once daily by mouth. LB-102 dosing starts at 25 mg daily for the first three weeks, with a possible increase to 50 mg daily from Week 4 based on clinical assessment scores. Patients on placebo will take one tablet daily for six weeks. Medication will be provided in weekly bottles, and both patients and study staff will be unaware of the treatment assignments. After completing the study treatment on Day 43, participants may resume antidepressant or mood stabilizer treatments if applicable. During the study, participants will undergo several assessments including measurement of depressive symptoms using the Montgomery sberg Depression Rating Scale MADRS-10 from baseline to Day 42. Researchers will also monitor adverse events and treatment-emergent mania symptoms using the Young Mania Rating Scale YMRS up to Day 56. The study includes regular visits for medication dispensing and clinical evaluations over the six-week treatment period, with participant health and safety closely observed throughout.

Researchers are evaluating the long-term safety and tolerability of a drug called NBI-1117568 in adults diagnosed with schizophrenia. This phase 3, open-label study aims to monitor participants over an extended period to better understand how the drug affects people with this condition and to gather important safety information. Participants in this study will take NBI-1117568 once daily by mouth for up to 36 months. This single treatment group will allow researchers to observe the effects of the medication over a long duration without comparing to a placebo or other treatments. During the study, researchers will track any treatment-emergent adverse events experienced by participants to assess safety. Participants will be monitored regularly throughout the 36 months for their health and response to the drug. This ongoing observation helps ensure participant well-being and collects valuable data on how the drug performs long-term.