Costa Mesa

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.

This research aims to evaluate the safety and effectiveness of increasing doses of NNC0662-0419 for adults living with obesity. The study is a phase 2 randomized trial comparing different dosing approaches of NNC0662-0419 and semaglutide, both administered by subcutaneous injection. Participants include adults with obesity who are committed to losing at least 25% of their body weight. Participants are randomly assigned to one of four groups receiving either NNC0662-0419 or semaglutide, or their matching placebos. All treatments are given by subcutaneous injection in a dose-escalation manner, meaning doses increase over time. This allows researchers to compare the safety and response to these drugs and their placebos. Throughout the study, participants are monitored for gastrointestinal side effects from week 0 to week 39. Body weight and body mass index BMI changes are also measured from week 0 to week 32. Participants will attend regular visits for dosing, safety assessments, and evaluations of weight and related health measures. The trial is expected to last until July 2027.

Researchers are conducting a Phase IbII, open-label, multicenter, randomized umbrella study to evaluate multiple immunotherapy-based treatment combinations in participants with advanced liver cancers. This study is designed to be flexible, allowing new treatment arms to open as new therapies become available and to close those with minimal activity or unacceptable toxicity. The initial focus is on participants with locally advanced or metastatic hepatocellular carcinoma HCC who have not received prior systemic therapy for their disease. Participants are randomly assigned to one of several treatment arms, receiving combinations such as atezolizumab plus bevacizumab, with additional drugs like tiragolumab, tocilizumab, TPST-1120, Tobemstomig, ADG126, IO-108, or NKT2152, depending on the arm. Treatments involve intravenous infusions or oral medications administered in cycles of 21 or 28 days, continuing until unacceptable toxicity or loss of clinical benefit occurs. Participants experiencing loss of benefit or toxicity during the initial stage may become eligible for a second stage involving different treatment combinations introduced via protocol amendments. Throughout the study, participants undergo regular assessments including radiographic and biochemical evaluations, biopsy when possible, and clinical status monitoring. The primary outcome is the objective response rate from randomization until disease progression or loss of clinical benefit, observed for up to 7 to 9 years. Secondary outcomes include progression-free survival, overall survival, duration of response, disease control, and the frequency of adverse events over the study period. The trial is sponsored by Hoffmann-La Roche and involves long-term monitoring until study completion in 2027.

Researchers are evaluating ITI-1284, a drug being studied for agitation associated with Alzheimers dementia. This Phase 2, multicenter, randomized, double-blind, placebo-controlled study aims to assess the efficacy, safety, and tolerability of ITI-1284 in patients aged 55 years and older who experience agitation related to Alzheimers disease. The study is sponsored by Intra-Cellular Therapies, Inc. and follows strict clinical criteria for diagnosis and agitation severity. Participants are randomly assigned in equal numbers to receive either ITI-1284 or a placebo. ITI-1284 is given as a rapidly disintegrating tablet taken once daily under the tongue at doses of 10 mg or 20 mg. The study consists of three periods a screening period lasting up to 4 weeks to assess eligibility, a 12-week double-blind treatment period where the assigned study drug is taken daily, and a 30-day safety follow-up period after the last dose to monitor any effects. During the study, participants will have assessments including the Cohen-Mansfield Agitation Inventory CMAI to measure agitation levels at Week 12. Other evaluations include the Clinical Global Impression-Severity CGI-S score and cognitive testing with the Mini-Mental State Examination. Safety monitoring occurs throughout the treatment and follow-up periods. Overall, participation lasts approximately 16 to 17 weeks, covering screening, treatment, and safety checks.

Researchers are evaluating whether adding immunotherapy drugs brentuximab vedotin and nivolumab to the standard treatment of chemotherapy with or without radiation improves survival for patients aged 5 to 60 with early stage classical Hodgkin lymphoma. This phase III trial compares progression-free survival and overall survival between the standard therapy and the immunotherapy-enhanced approach, as well as patient-reported outcomes and long-term side effects. Participants initially receive two cycles of ABVD chemotherapy every 28 days and then undergo imaging to classify their early response. Based on risk level and response, patients are assigned to one of eight treatment arms that include either continuing standard chemotherapy, receiving immunotherapy drugs, or combinations with involved-site radiation therapy. Treatments are delivered intravenously or orally in cycles lasting 28 days. Imaging and blood samples are collected throughout the trial. Participants are monitored regularly with PET scans, CT or MRI imaging, and blood tests. Follow-up visits occur every 3 months in the first year, then every 6 months for years two and three, and annually up to 12 years from registration. Researchers assess survival outcomes, adverse events, patient-reported symptoms and quality of life, and metabolic tumor burden. Long-term effects such as cardiovascular and pulmonary health are also evaluated using questionnaires and clinical assessments.

Researchers are evaluating a drug called DT-101 for adults with Major Depressive Disorder MDD, a form of depression. This study aims to learn if DT-101 can help treat depression when added to existing medication. The trial compares DT-101 against a placebo, which looks like the drug but contains no active medicine. Participants who qualify will be randomly assigned to receive either DT-101 or placebo for 8 weeks. During this time, they will continue their usual depression medication. The study includes physical and neurological exams, blood and urine tests, and clinical assessments to monitor safety and how the body processes DT-101. Participants will visit the clinic regularly for health checks and to complete questionnaires about their depression symptoms. Researchers will measure changes in depression severity using specific rating scales over 56 days. The study also collects data to analyze how well participants tolerate the drug and its effects on their condition.

Researchers are evaluating ACP-204, a drug targeting serotonin receptor subtype 2A, in adults aged 55 to 95 years with psychosis related to Alzheimers disease. This master protocol includes three independent, randomized, double-blind, placebo-controlled studies aimed at assessing the drugs efficacy and dose response. Substudy 1 is a Phase 2 trial comparing two doses of ACP-204 30 mg and 60 mg to placebo, followed by two Phase 3 confirmatory studies Substudies 2A and 2B that will independently evaluate the doses or a selected dose against placebo. Participants will undergo a screening period lasting up to 49 days before starting a six-week double-blind treatment phase where they will receive daily doses of ACP-204 or placebo, taken once a day at about the same time with or without food. After treatment, there is a 30-day safety follow-up for those not entering an open-label extension, and vital status follow-up for those who end the study early. Each substudy is analyzed separately to assess the drugs impact. During the trial, participants are closely monitored with assessments including the Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions SAPS-HD from baseline to week 6. Other evaluations include clinical global impression scales and safety monitoring. Participants must have a study partner or caregiver to assist with visits and adherence. The study is designed to track changes in psychosis symptoms and overall safety through the treatment and follow-up periods.

Researchers are evaluating two digital mindfulness-based interventions to improve mental health and well-being in younger breast cancer survivors who have elevated depressive symptoms. This phase III randomized trial focuses on women diagnosed at or before age 50, who completed primary cancer treatments at least six months earlier. The study aims to compare the effectiveness of live instructor-led sessions via Zoom and a self-paced app-based program, exploring which approach best supports psychological health in this population. Participants will be assigned to one of three groups the live online mindfulness sessions MAPs LO conducted weekly for 6 weeks via Zoom, the MAPs App delivering the same content in shorter sessions over 6 weeks, or a meditation-only control group accessing guided audio meditations. Both English and Spanish speakers can participate in the live online and meditation groups, while the app is only available in English. Tablets and internet hotspots are provided if needed. All groups have access to the UCLA MARC mindfulness meditation app throughout the 6-month follow-up. During the study, participants will attend weekly sessions for the live group or engage with app content at home, with usage tracked to measure intervention dose. Researchers will assess depressive symptoms shortly after the intervention and again up to 6 months later, along with fatigue symptoms. They will also investigate factors influencing intervention effects, such as baseline distress and social determinants, and evaluate the cost-effectiveness of the programs. The total study duration includes a 6-week intervention period plus follow-up assessments out to 6 months.

Researchers are studying how well inotuzumab ozogamicin works when combined with frontline chemotherapy in treating young adults aged 18 to 39 years with newly diagnosed B acute lymphoblastic leukemia that is CD22 positive. This phase III trial investigates the side effects and effectiveness of this combination compared to chemotherapy alone, aiming to improve event-free survival and other outcomes. The study also explores genetic and molecular markers to better understand treatment response and risks. Participants receive a pediatric-inspired chemotherapy regimen called CALGB 10403, which includes multiple courses of treatment remission induction, remission consolidation, interim maintenance, delayed intensification, and maintenance therapy. Some patients also receive inotuzumab ozogamicin intravenously on specific days, followed by blinatumomab if minimal residual disease is detected. Treatment cycles repeat according to response and tolerance, with additional therapies like rituximab and radiation as needed. Imaging and laboratory tests are done throughout. During the trial, participants undergo regular assessments including bone marrow biopsies, blood tests, and imaging such as echocardiography or multigated acquisition scans. Researchers measure outcomes like event-free survival, disease-free survival, overall survival, response rates, and treatment side effects for up to 10 years. After treatment, patients are followed closely every few months for up to 10 years to monitor long-term effects and disease status.

Researchers are evaluating Lumateperone as a treatment for adults with developmental stuttering, also known as childhood-onset fluency disorder. This double-blind, placebo-controlled Phase 2 trial focuses on adults aged 18 to 65 with moderate to severe stuttering symptoms. The study aims to assess both the effectiveness and tolerability of Lumateperone in reducing stuttering. Participants will be randomly assigned to receive either Lumateperone tablets, taken once daily with flexible dosing from 21 mg up to 42 mg, or a matching placebo. The trial uses a parallel design and includes multiple outcome assessments such as the Maguire-Leal-Garibaldi Self-Rated Stuttering Scale MLGSSS, Clinical Global Impression scales, and other measures of stuttering severity and side effects. The study is planned to enroll 24 subjects, with screening of about 30 to find suitable candidates. During the study, participants will undergo thorough clinical screening and provide written consent before enrollment. Researchers will collect various clinical scales and samples, including stuttering severity instruments and assessments for psychiatric and movement-related side effects. The primary outcomes include changes in stuttering severity and global impression of symptoms over the past week. The total study period extends until late 2027, with ongoing monitoring of efficacy and safety throughout the trial.