Belmont

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 safety and effectiveness of KarXT in adults aged 55 to 90 who have mild to severe Alzheimer's Disease (AD) accompanied by moderate to severe psychosis related to AD. This phase 3 study aims to better understand how KarXT compares to a placebo in treating the psychotic symptoms associated with Alzheimer's Disease. Participants must have documented AD diagnosis and a history of psychotic symptoms lasting at least two months prior to starting the study. Participants will receive either KarXT or a placebo, with specified doses given on designated days. The study is designed as a randomized, double-blind, placebo-controlled trial with parallel groups to assess the treatment's effects. Details about dosing schedules and administration are planned but not specified here. During the study, researchers will measure changes from baseline in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score up to week 14 to evaluate the impact on psychosis symptoms. Participants will undergo brain imaging (MRI or CT) if not already done within the past five years to rule out other conditions, and safety monitoring including laboratory tests will be conducted. The total participation duration covers screening through at least 14 weeks of treatment and assessment.

Researchers are evaluating a custom-formulated hemp-derived high-CBD product for its potential effects on anxiety and depression in adults with bipolar disorder. This phase 2 pilot open-label clinical trial focuses on individuals aged 18 to 65 who experience moderate anxiety and are on stable medication regimens. The study is motivated by preliminary data suggesting cannabidiol may have anti-anxiety and antidepressant properties, and it seeks to explore these effects specifically in bipolar disorder patients experiencing anxiety. The study involves a four-week treatment period during which participants self-administer a high-CBD solution under the tongue twice daily. Before starting treatment, participants undergo pre-screening by phone, followed by a hospital screening visit involving clinical interviews, questionnaires, urine and blood tests, and genetic sampling. Weekly in-person or remote visits are scheduled throughout the treatment to monitor mood and quality of life. After completing the four weeks of treatment, participants return for a final hospital visit to complete additional questionnaires and cognitive assessments. Participants are closely monitored with structured clinical interviews, quality of life and mood questionnaires, cognitive assessments, and laboratory tests. The primary outcome is the change in self-reported anxiety ratings using the Beck Anxiety Inventory after four weeks. Safety monitoring includes screening for liver function and other health measures. The total participation time includes the screening, four weeks of treatment with weekly check-ins, and a final assessment visit.

Researchers are studying the Nociceptin/Orphanin FQ receptor system in the brains of people who currently have or have had major depressive disorder (MDD). The study also looks at how these individuals make decisions and which brain areas are involved. They use MRI, PET scans, blood and saliva samples, and behavioral tasks to better understand and predict future depressive symptoms. Participants will undergo a task involving approach and avoidance decisions while having functional MRI scans. A resting PET scan will be done using a special tracer that targets the Nociceptin/Orphanin FQ receptor. A mild electrical stimulus will be given to the ankle as an aversive stimulus calibrated to be uncomfortable but not painful. Blood samples will be taken during the PET scan to measure receptor levels. During the study, participants will complete clinical interviews and behavioral tests at the start and follow-up visits at 6 and 12 months. Assessments include MRI, PET scans, saliva cortisol tests, and arterial blood draws. Researchers aim to track changes from baseline and identify brain markers that predict the course of depression. Participants must have a smartphone for ecological momentary assessment and be monitored for safety throughout the study.

Researchers are studying the early stages of psychotic disorders such as schizophrenia, schizoaffective disorder, bipolar I disorder, and other related conditions in adults aged 18 to 40. The study aims to identify biological markers and clinical features that can predict how well individuals respond to coordinated specialty care, with a focus on understanding different biotypes that may influence treatment outcomes. The goal is to improve treatment planning by using a combination of brain function, genetics, and cognitive measures to predict recovery and relapse in early psychosis. Participants will undergo a series of assessments including brain scans (MRI), eye movement tracking, EEG to measure brain waves, and neuropsychological tests. Data collection occurs at baseline and follow-up visits at 1, 6, and 12 months. DNA samples may also be collected for genetic analysis. The study involves four visits over about a year, with comprehensive evaluations designed to track changes in symptoms, cognition, and brain function over time. The research is conducted across multiple sites with coordinated specialty care programs. During the study, participants will complete clinical interviews, family and psychiatric history assessments, and cognitive testing. Screening includes drug tests and pregnancy tests for eligible women. Researchers will monitor treatment response, symptom remission, functional remission, and relapse over one year. This detailed tracking aims to provide insights into the course and outcomes of early psychosis, helping guide personalized treatment approaches. The total participation time is approximately one year with multiple assessments to measure progress and changes.

Researchers are studying cognition in people with psychotic disorders such as schizophrenia, bipolar disorder, and schizoaffective disorder. The main goal is to see if magnetic stimulation can affect how quickly people solve challenging tasks. This research explores whether cognitive performance in these disorders can be changed using non-invasive techniques, as cognitive impairments are major contributors to disability and poor quality of life in psychosis. The study uses different types of transcranial magnetic stimulation (TMS), including intermittent theta burst stimulation (iTBS), continuous theta burst stimulation (cTBS), and sham rTMS, which does not significantly change brain activity. These devices deliver magnetic pulses to alter brain circuits involved in cognition. Participants will receive these TMS treatments while researchers measure changes in brain function and cognitive performance. Participants will perform problem-solving tasks and undergo brain scans before and after TMS on three separate visit days. Assessments include BACS Symbol Coding and Digit Sequence tests conducted minutes before and after TMS, as well as functional magnetic resonance imaging (MRI) scans. The study monitors how TMS affects processing speed and brain activity, aiming to better understand cognitive changes in psychotic disorders.

Researchers are studying the effects of a noninvasive brain stimulation technique called transcranial magnetic stimulation (TMS) on hyperphagia and feelings of fullness in people with Prader-Willi syndrome. This study aims to better understand how TMS might influence brain activity related to hunger and satiety by focusing on a cerebellar satiety circuit. Participants will receive repetitive transcranial magnetic stimulation (rTMS), which uses a magnetic field generated by a coil placed on the scalp to temporarily alter neural activity. This method can modulate brain circuits without surgery or implants. The study will monitor changes in brain responses and satiety following this stimulation. During the study, participants will have brain imaging and follow-up assessments one week after TMS treatment. Researchers will track how many participants complete the study visits, the time needed to enroll subjects, and changes in brain activity measured by blood oxygen level-dependent (BOLD) responses. The total participation period includes baseline and one-week post-TMS assessments.

Researchers are investigating the neurobiological effects of severe childhood adversity, which is linked to a significantly higher risk of major depressive disorder (MDD) and other psychiatric illnesses. This study focuses on understanding oxidative stress abnormalities in the brain, as well as structural and molecular changes, to explain why some individuals develop mental health challenges while others remain resilient. The research aims to fill gaps in knowledge about how early life stress impacts brain function related to depression. The study involves female participants aged 20 to 32 who have experienced severe childhood adversity. Participants must be right-handed, unmedicated at enrollment, and fluent in English. The research includes functional, structural, and molecular brain imaging techniques to assess oxidative stress, brain structure, and glutamatergic function. The study does not involve any pharmacological or behavioral interventions but uses advanced imaging to understand brain changes associated with early life stress. Participants will undergo neuroimaging and assessments measuring immuno-oxidative abnormalities at baseline. Researchers will evaluate brain function and structure, collect medical and psychiatric histories, and assess risk factors for depression. Safety monitoring includes screening for suicidal ideation and other medical conditions. The study is designed to identify neurobiological markers that could help predict vulnerability or resilience to depression after childhood adversity, aiming to improve targeted interventions in the future.

Researchers are evaluating the safety and effectiveness of Magnesium-vitamin B6 combined with standard treatment for managing symptoms of depression, stress, and anxiety in people who have experienced their first episode of bipolar I disorder. This Phase 2, randomized, double-blind, placebo-controlled trial focuses on patients early in their illness, as mood and anxiety symptoms can significantly impact recovery and increase the risk of relapse and disability. The study also explores how Magnesium-vitamin B6 affects brain magnesium levels and energy metabolism using specialized magnetic resonance spectroscopy techniques. Participants will receive either Magnesium citrate (100 mg) with Pyridoxine hydrochloride (10 mg) tablets or placebo tablets, taken three times daily for four weeks alongside their usual treatment. The trial compares these two groups to assess the potential benefits of the supplement combination on depressive and anxiety symptoms and stress. The study design ensures neither participants nor researchers know who receives the active treatment or placebo to maintain objectivity. During the study, participants will undergo assessments of their depressive symptoms to measure changes over the four-week treatment period. Researchers will also monitor brain chemistry changes through imaging and track safety and tolerability. Participants must maintain stable psychiatric medication use during the trial and will be evaluated for various health and psychiatric conditions to ensure safety and study compliance. The total study duration includes screening, four weeks of treatment, and follow-ups to observe outcomes and any side effects.

Researchers are evaluating the effect and safety of Electroconvulsive Therapy (ECT) combined with usual care in reducing severe agitation among patients with moderate to severe dementia. This includes various types of dementia such as Alzheimer's Disease, Vascular dementia, Frontotemporal dementia, and Dementia with Lewy Bodies. The study is a single-arm, unblinded, non-randomized trial focused on assessing both treatment effects and safety outcomes, with an exploratory phase to observe the long-term durability of the treatment effect over 12 months. Participants will receive ECT treatments using a right unilateral (RUL) electrode placement and ultra-brief pulse widths. The first session will determine the seizure threshold through titration, and subsequent sessions will deliver a dose approximately six times that threshold. Treatment settings may be adjusted based on seizure quality and effectiveness. All participants will be given anesthesia during the ECT treatments. After the initial treatment phase, participants will enter a 12-month naturalistic follow-up period to monitor ongoing effects. During the study, participants will be assessed using the Cohen-Mansfield Agitation Inventory (CMAI) throughout the approximately 13-month duration. Researchers will monitor safety, tolerability, and treatment response through physical exams, lab tests, and brain imaging when indicated. The study aims to enroll 50 participants, with an expected 20% dropout rate, and requires participants to have severe agitation and be medically stable for ECT treatment. The study also involves consent from authorized legal representatives due to the cognitive status of participants.