Lauderhill

Researchers are evaluating the safety and effectiveness of the Vagus Nerve Stimulation VNS Therapy System as an additional treatment for people with treatment-resistant depression. This prospective, multi-center, randomized, controlled, and blinded trial compares active VNS therapy to a no stimulation control group in reducing depressive symptoms over 12 months. The study follows guidelines aligned with Medicare and Medicaid coverage decisions for VNS in this condition. Participants receive an implant of the VNS device and are randomized at least two weeks after implantation to either have the device activated or remain without stimulation for the first 12 months. After this initial period, those in the control group can begin stimulation. Following the 12-month randomized phase, all participants enter an open-label, longitudinal study lasting about five years, including new enrollees after the initial trial phase. During the study, participants are monitored through various depression rating scales, including the Montgomery sberg Depression Rating Scale MADRS, to assess response and remission rates up to 12 months. Safety is tracked by recording adverse events from implantation through the first year. Additional assessments include disability and health outcome scales, as well as suicidality tracking. The study aims to gather long-term data on treatment effects and participant well-being.

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 evaluating brenipatide, compared to a placebo, for adults with Alcohol Use Disorder AUD and hazardous alcohol use. This phase 3 study aims to assess whether brenipatide affects drinking patterns and cravings over approximately 56 weeks. The study is sponsored by Eli Lilly and Company and involves participants motivated to reduce or stop alcohol consumption. Participants receive escalating doses of brenipatide or placebo via subcutaneous injection. The study includes two experimental periods with LY3537031 brenipatide and a placebo group, all administered by injection. Participants who cannot self-inject may have assistance from a trained support person. The treatment phase lasts up to 56 weeks. During the study, participants attend scheduled visits and complete questionnaires and diaries to track alcohol use and cravings. Researchers monitor changes in drinking patterns using the Timeline Followback Method and assess alcohol craving, health outcomes, body weight, and potential immune responses to the drug. Safety and pharmacokinetics are also evaluated throughout the study duration.

Researchers are studying the effects of KarXT on bladder function and urological safety in adults diagnosed with schizophrenia according to DSM-5 criteria. This phase 4, open-label study aims to understand how KarXT influences urinary flow rates and residual urine volume over a 12-month period. The study is sponsored by Bristol-Myers Squibb and focuses on safety monitoring for participants with schizophrenia. Participants will receive KarXT, which consists of xanomeline and trospium chloride, administered at specified doses on designated days. The study lasts for 12 months, during which participants will be observed for changes in their urinary function and safety parameters related to the medication. No placebo or comparison group is mentioned, and the study is open-label, meaning both researchers and participants know the treatment being given. During the study, participants will undergo regular assessments including measurements of urinary flow and residual volume, urinalysis, symptom questionnaires, electrocardiograms, vital sign checks, and monitoring for adverse events including serious and special interest events. Researchers will also track any changes in suicidal thoughts or behaviors. The total participation duration is up to 12 months with ongoing safety and efficacy evaluations throughout this period.

Researchers are evaluating the effectiveness and safety of SPT-300 GlyphAllo, a drug being studied for adults with major depressive disorder MDD, including those with or without anxious distress. This is a phase 2, randomized, double-blind, placebo-controlled study designed to assess how well SPT-300 works and how well participants tolerate it. Participants will be randomly assigned to receive either SPT-300 capsules or a matching placebo once daily for 42 days. The study compares these two groups to understand the impact of SPT-300 as a monotherapy treatment for MDD. During the study, participants will be assessed for changes in depression severity using the Hamilton Depression Rating Scale-17 HAM-D-17 from the start to day 42 of treatment. Additional evaluations include clinical global impression severity scores. The trial includes monitoring for safety, tolerability, and other health measures throughout the 42-day treatment period.

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 study aims to understand how patient characteristics influence the drugs effectiveness when added to a mood stabilizer andor atypical antipsychotic treatment. The study also assesses safety, tolerability, and efficacy during an open-label treatment phase following the initial blinded period. Participants will be randomly assigned to receive either ALTO-100 40 mg tablets or a matching placebo twice daily for six weeks during the double-blind phase. Those who qualify and continue into the open-label phase will receive ALTO-100 40 mg tablets twice daily for up to seven additional weeks. The study involves careful monitoring of depressive symptoms using standardized rating scales and safety evaluations throughout both study periods. During the trial, participants will undergo regular assessments including the Montgomery-sberg Depression Rating Scale MADRS, Patient Health Questionnaire PHQ-9, and Clinician Global Impression Scale-severity CGI-S. Safety monitoring covers adverse events, vital signs like heart rate and blood pressure, weight, and suicidality using the CHRT-SR12 scale. The total study duration for each participant can extend up to 13 weeks, with close follow-up to evaluate treatment effects and safety.

Researchers are evaluating the safety and effectiveness of TSND-201 in adults diagnosed with Post Traumatic Stress Disorder PTSD who have had symptoms for at least six months. The study involves participants who have previously tried at least one medication or trauma-focused psychotherapy for PTSD. This phase 3 randomized, double-blind, placebo-controlled trial aims to compare two doses of TSND-201 capsules with a placebo to better understand treatment options for PTSD. Participants will enter a 4-week Treatment Period during which they will be randomly assigned to receive either one of two doses of TSND-201 or a placebo capsule once a week, taken orally. After completing this treatment phase, they will continue into an 8-week Follow-up Period to monitor their progress and any changes in their condition. The study uses a parallel design and masking to keep participants and researchers unaware of group assignments. During the study, participants will undergo assessments including the Clinician-Administered PTSD Scale for DSM-5 CAPS-5 to measure changes in PTSD severity from the start through 12 weeks. Researchers will also monitor safety and efficacy by evaluating participants regularly through interviews and questionnaires. The entire participation duration covers 12 weeks, including treatment and follow-up, with safety and response being closely observed throughout.

Researchers are evaluating the effects and safety of solriamfetol in adults with binge eating disorder BED. This Phase 3 trial compares two doses of solriamfetol 150 mg and 300 mg with a placebo to better understand their impact on BED symptoms. Participants must be aged 18 to 55 with a diagnosis of BED based on DSM-5 criteria. Participants will be randomly assigned to one of three groups receiving either solriamfetol 150 mg, solriamfetol 300 mg, or placebo tablets, all taken once daily for 12 weeks. This randomized, double-blind study will assess how these treatments affect binge eating episodes over the course of the trial. During the 12 weeks, participants will be monitored for changes in the number of binge eating episodes. Safety and efficacy will be evaluated through regular assessments. All study-related care, including medication and visits, will be provided at no cost, and the total participation duration is approximately 12 weeks.

Researchers are evaluating a single injection of RE104 for Injection to see if it reduces anxiety symptoms in adults with Generalized Anxiety Disorder GAD. This Phase 2 trial compares the effects of RE104 against a placebo in a randomized, double-blind, placebo-controlled setting to understand its impact on anxiety levels. Participants receive either a single subcutaneous injection of 30 mg RE104 or a placebo 0.9% sodium chloride during the study. The trial uses a parallel design where each participant is randomly assigned to one of the two groups. The main treatment effect is measured at 4 weeks after dosing, and follow-up assessments continue up to 12 weeks to monitor anxiety symptoms and any adverse events. During the study, participants will undergo evaluations including the Hamilton Anxiety Rating Scale HAM-A and Hospital Anxiety and Depression Scale HADS at multiple time points. Researchers will assess changes in anxiety scores, response rates, remission rates, and safety by monitoring treatment-emergent adverse events. The total follow-up after dosing lasts 12 weeks, with scheduled assessments at weeks 1, 2, 4, 8, and 12 to track progress and safety.

Researchers are evaluating the effectiveness, safety, and tolerability of ITI-1284 as an additional treatment for adults with generalized anxiety disorder GAD who have not responded well to their current GAD medications. This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial conducted by Intra-Cellular Therapies, Inc. Participants must meet specific diagnostic criteria for moderate to severe GAD and show inadequate response to standard treatments. The study consists of three periods a screening phase lasting up to 3 weeks to assess eligibility and allow for medication washout a 6-week double-blind treatment phase where participants are randomly assigned to receive either ITI-1284 at 10 mg, ITI-1284 at 20 mg, or a placebo, all given once daily as sublingual tablets and a 1-week safety follow-up period. Participants continue their existing GAD treatment during the study. During the trial, participants will undergo various assessments including anxiety severity ratings using the Hamilton Anxiety Rating Scale HAM-A and the Clinical Global Impression Scale-Severity CGI-S at week 6. Safety and tolerability will be monitored throughout, with a follow-up visit after the treatment phase. Overall participation spans approximately 10 weeks including screening and follow-up.