Princeton

Researchers are evaluating the safety, tolerability, and effectiveness of CYB003, a Deuterated Psilocin Analog, compared to a placebo when added to current antidepressant treatment in adults with moderate to severe Major Depressive Disorder (MDD). This Phase III trial focuses on participants aged 18 to 85 years who have had inadequate response to a stable antidepressant dose, aiming to better understand how CYB003 might improve depressive symptoms. Participants receive oral doses of CYB003 or matching placebo along with manualized psychological support provided by trained facilitators. The treatment period includes multiple dosing sessions with monitoring and assessments throughout. Placebo is used as a comparator to evaluate the combined safety and efficacy of CYB003 in this population. During the study, participants undergo evaluations using the Montgomery-Åsberg Depression Rating Scale (MADRS) at several time points, including screening, baseline, and multiple days up to the end of treatment at Day 42. Researchers monitor symptoms, side effects, and overall safety. Participants provide informed consent and are assessed regularly to track changes in depression severity and any adverse events over the course of the study.

Researchers are evaluating two investigational drugs, 68Ga-R11228 and 177Lu-R11228, in patients with metastatic or locoregionally recurrent estrogen and/or progesterone receptor-positive (ER+/PR+) and HER2-negative breast cancer. This phase 1 study aims to assess the safety and effectiveness of these drugs in detecting and treating tumor lesions. The study includes patients who have hormone receptor-positive breast cancer that has recurred or spread and focuses on understanding adverse events and dose-limiting toxicities associated with the treatments. The study has two parts. Part A tests 68Ga-R11228, a gallium-labeled radioligand designed to locate tumor lesions and make them visible on PET scans. Participants receive a single dose at one of three dose levels. Part B tests both 68Ga-R11228 for imaging and 177Lu-R11228, a lutetium-labeled radioligand designed to treat tumor lesions identified by PET scans. Eligible patients in Part B receive up to six doses of 177Lu-R11228 over approximately 36 weeks, with multiple dose levels evaluated. After treatment, participants enter a 5-year follow-up period to monitor long-term effects. Participants will undergo PET scans to identify tumor lesions and receive the investigational drugs as scheduled. Researchers will monitor safety by tracking adverse events and serious adverse events from Day 1 through Week 36, as well as dose-limiting toxicities. Assessments include clinical examinations, brain imaging for those with prior brain metastases, and laboratory tests to evaluate bone marrow, liver, and kidney function. The total involvement includes treatment periods and long-term follow-up to ensure participant safety and gather comprehensive data on the drugs' effects.

Researchers are evaluating the safety and effectiveness of two combined treatments, KarXT and KarX-EC, for adults aged 55 to 90 who experience agitation related to Alzheimer's Disease. This Phase 3, randomized, double-blind, placebo-controlled study aims to better understand how these treatments may help reduce agitation symptoms in this population while monitoring safety. Participants will receive either the active drugs Xanomeline/Trospium Chloride Capsule and Xanomeline Enteric Capsule or a placebo, taken at specified doses on designated days. The study is carefully designed to compare these treatments against placebo to evaluate their impact on agitation symptoms associated with Alzheimer's Disease. During the study, participants will be assessed using the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) total score to measure changes from baseline at Week 14. Caregivers will be involved to help monitor compliance and report participant status throughout the study. Safety and efficacy will be closely monitored during this 14-week period to gather detailed information about treatment outcomes.

Researchers are evaluating the clinical efficacy, safety, and tolerability of azetukalner as a monotherapy in adults diagnosed with moderate-to-severe Major Depressive Disorder (MDD). This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on participants aged 18 to 74 who have experienced their first major depressive episode before age 50. The study aims to compare azetukalner with placebo in treating MDD over a 6-week period. Participants will receive either azetukalner 20 mg or placebo orally once a day with food, preferably with the evening meal, for 6 weeks. The treatment is administered as a daily oral dose, and participants are randomly assigned to one of the two groups. The study is designed to maintain blinding of treatments to both participants and researchers. During the study, participants' depression symptoms will be assessed using the Hamilton Depression Rating Scale (HAMD-17) to measure changes from baseline to Week 6. Researchers will also monitor safety and tolerability throughout the treatment period. Participants will undergo regular evaluations, and the study includes careful screening to ensure eligibility and monitor any adverse effects during the 6 weeks of treatment.

Researchers are collecting baseline growth data in children with idiopathic short stature (ISS) to better understand their growth patterns. This observational study includes children diagnosed with ISS who meet specific height and growth criteria, aiming to gather detailed growth measurements and related variables over time. The study does not involve any treatment interventions but focuses on monitoring growth changes in children who may or may not be receiving human growth hormone (hGH) therapy. Participants include those who have never received hGH and those currently on treatment. The study observes growth parameters such as height, height Z-score, BMI, and BMI Z-score every six months. Participants are involved in regular assessments every six months, continuing up to 15 years. These evaluations measure annualized growth velocity, standing height, height Z-score, BMI, and BMI Z-score to track their growth progress. The study relies on ongoing monitoring to understand growth changes in children with ISS over an extended period.

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 copper Cu 64 PSMA I&T injection for PET/CT imaging in men newly diagnosed with unfavorable intermediate, high, or very high-risk prostate cancer. This prospective, open-label Phase 3 study focuses on patients planning to undergo radical prostatectomy with pelvic lymph node dissection to assess the diagnostic accuracy of this imaging method. Each participant will receive an intravenous dose of approximately 8 mCi of copper Cu 64 PSMA I&T. PET/CT scans will be performed between 1 and 4 hours after injection. Three independent readers, blinded to patient information, will interpret the images to identify prostate cancer lesions in pelvic lymph nodes, prostate, extra pelvic lymph nodes, bones, and other tissues. The results will be compared to histopathology and conventional imaging to determine sensitivity and specificity. Participants will undergo baseline conventional imaging and have their PET/CT scans evaluated for cancer detection. The study will measure the accuracy of copper Cu 64 PSMA I&T PET/CT in detecting prostate cancer lesions compared to the reference standard of histopathology. Safety monitoring and image interpretation consistency will be maintained throughout the study, which involves approximately 439 patients.

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 surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating a new behavioral intervention to reduce the spontaneous return of threat expectation in healthy adults. The study focuses on how fear can reappear after exposure therapy by examining spontaneous recovery behavior using a laboratory model of Pavlovian conditioning and extinction. The goal is to test if strengthening memory control ability, through a functional brain connection, can lower this return of fear. Participants receive either active real-time functional magnetic resonance imaging (fMRI) neurofeedback, which targets a connection between the prefrontal cortex and hippocampus linked to memory control, or sham placebo neurofeedback as a control. The active neurofeedback provides positive feedback when it detects brain activity patterns associated with successful memory inhibition. This intervention aims to help participants increase their ability to control memories related to threat learning. During the study, participants complete up to four fMRI sessions over a period of no more than 60 days, including baseline and follow-up scans. Researchers measure spontaneous recovery behavior as the primary outcome. Participants undergo behavioral tests, neurofeedback sessions, and assessments to track brain activity and threat response. Eligibility includes healthy adults aged 18 to 50, with specific requirements like right-handedness, normal color vision, and the presence of spontaneous recovery behavior in a prescreening session.