Belmont

Researchers are evaluating a new treatment for adults with borderline personality disorder BPD who experience suicidal thoughts. This study aims to assess how many participants complete the treatment, how they feel about it, whether it causes changes in brain activity, if it improves BPD symptoms, and whether any benefits last over time. The research is sponsored by Mclean Hospital and involves a pilot trial of combined therapy. Participants will take a single dose of the medication D-cycloserine the night before the treatment day. On the treatment day, they will receive up to 20 short sessions of transcranial magnetic stimulation TMS, each lasting about 3 minutes and separated by 30-minute breaks, lasting up to 12 hours total. This is an open-label study without a comparison group. Throughout the study, participants will visit the clinic for interviews and testing. They will complete weekly questionnaires for 4 weeks before treatment and for 6 weeks after the treatment day. Researchers will measure acceptability of the intervention, brain activity changes using motor-evoked potentials, and BPD symptom scales at multiple time points to track outcomes and safety over about 11 weeks.

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 the safety and effectiveness of KarXT in adults aged 55 to 90 with mild to severe Alzheimers Disease who experience moderate to severe psychosis related to this condition. This Phase 3 trial aims to study KarXT compared to a placebo to better understand its impact on psychotic symptoms associated with Alzheimers. Participants will be randomly assigned to receive either KarXT or a placebo at specified doses on certain days. The study lasts up to 14 weeks, during which changes in psychosis symptoms, as measured by the Neuropsychiatric Inventory-Clinician Hallucinations and Delusions score, will be closely monitored. Additional assessments include cognitive tests and monitoring for side effects. During the trial, participants will undergo regular evaluations including symptom ratings, cognitive tests such as the Mini-Mental State Examination, laboratory tests, and safety monitoring. Researchers will track any adverse events and changes in mental and physical health. The study aims to provide detailed information about how KarXT affects psychosis and cognition in Alzheimers disease over the treatment period.

Researchers are evaluating a custom-formulated, hemp-derived high-CBD product in adults with bipolar disorder who experience anxiety. This pilot open-label clinical trial aims to explore the potential anti-anxiety and antidepressant effects of cannabidiol CBD over four weeks. Despite interest in cannabinoid products, this is the first clinical trial focusing on hemp-derived CBD in this population. Participants will self-administer the high-CBD solution under the tongue twice daily for four weeks. The study involves an initial phone pre-screening, followed by an in-person screening visit with interviews, questionnaires, urine and blood tests, and genetic sampling. Weekly visits, either in person or remote, will monitor mood and quality of life, ending with a final visit to complete more assessments and cognitive testing. Throughout the study, participants will complete various clinical and quality of life questionnaires, cognitive assessments, and genetic testing. Researchers will measure changes in anxiety using the Beck Anxiety Inventory as the primary outcome, with depression changes as a secondary measure. Safety and adherence will be monitored during weekly visits, and the total participation lasts approximately four weeks after screening and baseline assessments.

Researchers are studying the potential effects of a high-cannabidiol CBD sublingual product on gynecologic pain in individuals with endometriosis, adenomyosis, or chronic pelvic inflammatory disease PID. This clinical trial is double-blind, placebo-controlled, and focuses on understanding specific targets and mechanisms of a hemp-derived, full-spectrum, high-CBD product for managing these conditions. Participants will be randomly assigned to receive one of two doses of the high-CBD product or a placebo. The study involves self-administration of the assigned product three times daily for one week. A subset of participants may undergo additional pharmacokineticpharmacodynamic studies involving extended blood sampling and questionnaires to better understand the bodys response to the CBD product. During the study, participants will attend three visits including screening, baseline, and final visits. These visits include clinical interviews, medical screenings, urine and blood sample collections, questionnaires, and sensory testing. Researchers will measure levels of CBD and its metabolites, inflammatory markers, and circulating anandamide at the start and end of the study. Participants will track their product use and may receive additional compensation if participating in extended procedures. The study aims to assess treatment effects over the 7-day period.

Researchers are studying the role of the NociceptinOrphanin FQ receptor system in the brains of adults aged 18 to 45 with current or past major depressive disorder MDD. The study aims to understand how this receptor system affects decision-making and brain activity related to approach and avoidance behaviors. It also explores stress-related inflammation and neural markers that may predict future depressive symptoms. Participants will undergo functional magnetic resonance imaging fMRI while performing decision-making tasks, as well as resting positron emission tomography PET scans using a special tracer targeting the NociceptinOrphanin FQ receptor. The study includes people with current MDD, those with a history of MDD, and control subjects without neurological or psychiatric illness. An aversive device delivers mild electrical stimulation to the ankle, and blood will be drawn during PET scans to measure relevant biological markers. During the study, participants will complete clinical interviews, behavioral tasks, and multiple questionnaires assessing mood, stress, and quality of life. Biological samples such as saliva and blood will be collected, and imaging data will be analyzed. Follow-up clinical interviews and assessments will occur at 6 and 12 months after PET scans to monitor changes. The study involves detailed tracking of brain function, behavior, and biological signals over time to better understand depression.

Researchers are evaluating treatment options for adults aged 18 to 35 experiencing their first episode of psychosis who also have specific genetic markers that may influence their response to antipsychotic medications. The study aims to compare the effects of early treatment with clozapine against standard treatments with risperidone or aripiprazole in patients identified as biomarker positive for better response and lower risk of certain side effects. Participants will be screened using brain imaging rs-fMRI and genetic blood tests to identify three biomarkers related to treatment response, risk of weight gain, and risk of agranulocytosis. Those who meet all biomarker criteria will be randomly assigned to receive clozapine, risperidone, or aripiprazole, each given in titrated doses according to the study protocol. The treatments will be administered under careful monitoring during the study period. Throughout the study, participants will undergo assessments including symptom rating scales like the Brief Psychiatric Rating Scale BPRS, weight monitoring, blood tests for agranulocytosis and neutropenia, and brain scans as needed. These measurements will be taken over 12 weeks to evaluate changes in symptoms and side effects. The study involves regular visits and monitoring to ensure safety and adherence, with the total participation lasting up to 12 weeks after enrollment.

Researchers are studying the early stages of psychotic disorders such as Schizophrenia, Schizoaffective Disorder, and Bipolar I Disorder to better understand their progression and how biological markers and different patient types may predict treatment response. This observational study involves a large sample across multiple sites, aiming to identify clinical and biological predictors of outcomes to improve personalized care for individuals with early psychosis. Participants receive coordinated specialty care and undergo a series of assessments including brain scans MRI, eye-tracking, EEG, DNA collection, and neuropsychological testing at baseline and follow-up visits at 1, 6, and 12 months. These procedures help gather data on brain function, genetics, and cognitive abilities. The study categorizes participants into biotypes based on biomarker profiles to explore their relation to treatment outcomes. Participants are involved for about one year, attending four visits where clinical interviews, cognitive tests, and biomarker assessments are conducted. Screening takes about three hours and includes drug and pregnancy testing, psychiatric and medical history reviews. Researchers track outcomes such as treatment response, symptomatic and functional remission, and relapse over the study period to gain insight into early psychosis and guide future care strategies.

Researchers are investigating cognition in psychotic disorders such as schizophrenia, bipolar disorder, and schizoaffective disorder. The study aims to understand if magnetic stimulation can influence processing speed, which reflects how quickly people solve challenging tasks. This research focuses on cognitive impairments that contribute to disability and poor quality of life, exploring a non-invasive method to temporarily alter brain activity. Participants will undergo different types of transcranial magnetic stimulation TMS including intermittent theta burst stimulation iTBS, continuous theta burst stimulation cTBS, and a sham placebo version. Each participant completes brain scans using magnetic resonance imaging MRI and cognitive testing before and after TMS sessions to observe changes in cognitive performance and brain circuits. The study uses these methods to compare the effects of the various TMS patterns on cognition. During the study, participants perform cognitive tasks and have MRI scans several times to measure brain activity and processing speed before and after each TMS session. The main outcomes measured include scores on cognitive tests such as the BACS Symbol Coding and BACS Digit Sequence tests, as well as functional MRI results. This study involves a randomized design with single masking and follows participants through multiple TMS visits to assess changes over time.

Researchers are studying how a noninvasive brain stimulation technique called repetitive transcranial magnetic stimulation rTMS might affect hunger and feelings of fullness in people with Prader-Willi syndrome. This condition is associated with severe overeating, and the study aims to understand how stimulating a specific brain area, the cerebellum, may impact these symptoms. The study is sponsored by Brigham and Womens Hospital and involves adults aged 18 to 64 years. Participants will receive daily targeted rTMS treatments to the cerebellum for one week. This procedure uses a magnetic coil held by the scalp to create a magnetic field that temporarily changes brain activity. The rTMS method used, called intermittent theta burst stimulation iTBS, is designed to modulate brain circuits linked to appetite control. During the study, participants will be monitored at baseline and then again one week after the rTMS treatment to measure brain responses using BOLD imaging and to assess retention in study assessments. Researchers will also track how long it takes to enroll subjects over the course of up to 18 months. The study does not involve masking or placebo and focuses on understanding brain function related to hyperphagia in Prader-Willi syndrome.