Lauderhill

Researchers are evaluating the safety and effectiveness of Vagus Nerve Stimulation (VNS) Therapy as an additional treatment compared to no stimulation in people with treatment-resistant depression. This prospective, multi-center, randomized, controlled, blinded trial focuses on reducing depressive symptoms over 12 months using multiple depression rating scales. The study follows guidelines from the Centers for Medicare and Medicaid Services regarding evidence development for this treatment. Participants receive implantation of the VNS device, which delivers stimulation to the vagal nerve. After a minimum two-week period post-implantation, participants are randomly assigned to either active VNS treatment or no stimulation control, with outcomes observed for 12 months. Following this randomized phase, all participants enter an open-label extension where those in the control group receive active stimulation. Additional subjects may join this open-label study for up to five years to further assess long-term effects. Throughout the study, participants undergo regular assessments including the Montgomery Åsberg Depression Rating Scale (MADRS), WHO Disability Assessment Schedule, Health Outcome Scale, Clinical Global Impressions Scale, and Suicidality Tracking Scale. Researchers monitor response rates, remission times, duration of effects, and adverse events from implantation through 12 months. This comprehensive evaluation includes safety monitoring and functional outcome measures to understand the impact of VNS therapy on depression and related disabilities.

Researchers are evaluating the safety and effectiveness of brenipatide combined with standard care compared to a placebo with standard care in adults with schizophrenia. This phase 2 study aims to understand how well brenipatide works as an additional treatment for schizophrenia and monitor any side effects. Participants eligible for the study must have schizophrenia and be on stable standard care medication. The trial consists of three main periods: a screening period lasting about one month, a treatment period that can last up to 12 months, and a follow-up period of approximately two months. During the treatment phase, participants receive either brenipatide or placebo administered by subcutaneous injection alongside their standard care. The study includes careful monitoring and adherence to study procedures such as self-injection, keeping diaries, and completing questionnaires. Participants will be involved in regular visits and assessments throughout the entire study duration, which may last up to 15 months. Researchers will measure changes in body weight from baseline to week 52 as a primary outcome. Participants will also be monitored for safety and efficacy through ongoing evaluations, including the use of electronic or paper diaries and required questionnaires to track their progress and response to treatment.

Researchers are evaluating the effectiveness and safety of brenipatide compared to a placebo in adults with Alcohol Use Disorder (AUD) and hazardous alcohol use. This Phase 3, multicenter, randomized, double-blind study aims to understand if brenipatide can help participants reduce or stop drinking. The study lasts approximately 56 weeks and focuses on changes in drinking patterns using the Timeline Followback Method (TLFB). Participants will receive either brenipatide (LY3537031) or a placebo, both administered by subcutaneous injection. Participants who cannot self-inject will have assistance from a trained support person. They are expected to store and use the blinded study drug as directed, maintain electronic and paper diaries, and complete questionnaires throughout the study. During the study, participants will have scheduled visits to monitor their progress, including assessments of drinking behavior and safety evaluations. Researchers will measure changes in alcohol use patterns up to 56 weeks. Participants must be motivated to reduce or stop drinking and be available for all study visits and procedures. Safety and adherence will be closely monitored throughout the trial.

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.

Researchers are evaluating the antidepressant effects of ALTO-100 compared to a placebo in adults with Bipolar Disorder I or II who are currently experiencing a major depressive episode. This Phase 2 study focuses on patients who are also taking mood stabilizers and/or atypical antipsychotic medications. The study aims to understand differences in efficacy related to patient characteristics, while also assessing safety and tolerability. Participants will receive either ALTO-100 at a dose of 40 mg twice daily or a matching placebo tablet twice daily during the Double-Blind period. Following this, there will be an open-label treatment phase to further evaluate safety, tolerability, and effectiveness. All treatments are given alongside the patient’s existing mood stabilizer and/or atypical antipsychotic therapy. Throughout the study, participants will be regularly assessed for changes in depression symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS) from Day 1 through Week 6. Researchers will monitor safety and tolerability during both the double-blind and open-label phases. The study involves ongoing compliance with assessments and procedures to track treatment effects and participant well-being.

Researchers are evaluating the safety and effectiveness of TSND-201 capsules for adults diagnosed with Post Traumatic Stress Disorder (PTSD). This Phase 3 trial includes participants who meet the DSM-5 criteria for PTSD with symptoms lasting at least six months and who have previously tried at least one pharmacological or trauma-focused psychotherapy treatment. The study aims to measure changes in PTSD severity using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Participants will be randomly assigned in equal groups to receive either one of two doses of TSND-201 or a placebo. These treatments are given orally once a week over a four-week Treatment Period. After completing treatment, participants will enter an eight-week Follow-up Period to monitor ongoing effects and safety. During the study, participants will complete interviews and written questionnaires to assess their PTSD symptoms and overall health. Researchers will track changes in PTSD severity up to 12 weeks from the start of treatment. Safety monitoring will include assessments to ensure participants remain free from other significant illnesses and manage any side effects. The total participation time includes the four-week treatment and eight-week follow-up phases.

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 evaluating the safety and effectiveness of solriamfetol in adults aged 18 to 55 who have been diagnosed with binge eating disorder (BED) according to DSM-5 criteria. This Phase 3, randomized, double-blind, placebo-controlled study aims to better understand how solriamfetol affects BED by comparing it to a placebo over 12 weeks. Participants will be randomly assigned to one of three groups receiving either solriamfetol 150 mg, solriamfetol 300 mg, or a placebo. All treatments are given once daily during the 12-week study period. The study carefully monitors the impact of these treatments on the number of binge eating episodes. Throughout the study, participants will be assessed for changes in binge eating behavior from the beginning to the end of the 12 weeks. Safety and adherence to treatment will also be monitored. Participants provide written informed consent before starting and are regularly evaluated to ensure compliance and well-being during the trial.

Researchers are evaluating ITI-1284 as an additional treatment for adults with Generalized Anxiety Disorder (GAD) who have not responded well to their current GAD treatment. This Phase 2, multicenter, randomized, double-blind, placebo-controlled study aims to assess the effectiveness, safety, and tolerability of ITI-1284 in this population. Participants must meet specific diagnostic criteria for moderate or severe GAD and have shown inadequate improvement from at least one approved GAD medication. The study consists of three periods: a screening phase lasting up to 3 weeks to confirm eligibility and allow for withdrawal of prohibited medications; a 6-week double-blind treatment period where participants are randomly assigned to receive ITI-1284 at 10 mg, ITI-1284 at 20 mg, or a placebo, all administered once daily as sublingual tablets; and a 1-week safety follow-up period to monitor participants after treatment ends. During the study, participants will be closely monitored with assessments including the Hamilton Anxiety Rating Scale at week 6 to measure anxiety levels. Other evaluations include clinical interviews and safety checks to ensure participant well-being. The study tracks treatment adherence and collects data on the safety and tolerability of ITI-1284 throughout the treatment and follow-up periods.

This research aims to evaluate the long-term safety, tolerability, and effectiveness of NMRA-335140 in adults with major depressive disorder (MDD). It involves participants who completed earlier Phase 3 studies of NMRA-335140 for MDD and met specific eligibility and consent requirements. The study provides an opportunity to extend treatment and monitor outcomes over a longer period. Participants will receive NMRA-335140 at a dose of 80 mg taken orally once daily for a 52-week treatment period. This open-label extension allows continued assessment beyond the initial parent studies, focusing on sustained safety and effectiveness of the medication. Throughout the 52 weeks, researchers will monitor participants for treatment emergent adverse events and use validated clinical scales to assess safety and tolerability. The study's total duration for participants is up to 54 weeks, including safety assessments. Data collected will help understand the long-term effects of NMRA-335140 in managing MDD.