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Found 5 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are investigating a new approach to treat Alcohol Use Disorder (AUD) by targeting the kynurenine pathway (KP), which is involved in producing metabolites affecting brain function. Chronic alcohol use disrupts this pathway, lowering protective kynurenic acid (KYNA) and increasing harmful quinolinic acid (QUIN). Diclofenac, a widely used anti-inflammatory drug, has been found to inhibit an enzyme called kynurenine 3-monooxygenase (KMO), potentially restoring balance in the KP by increasing KYNA. This study aims to test whether diclofenac can increase KYNA levels in people with AUD and determine the most effective dose among 50 mg, 75 mg, and 100 mg. Participants with AUD will attend four sessions to receive one of three doses of diclofenac or a placebo. The study compares these doses to see which best raises KYNA. Diclofenac is given orally, and its effects on KYNA and QUIN, along with alcohol craving and mood, will be evaluated. This pilot study is designed as a Phase 1 trial focusing on diclofenac's dosing, safety, and initial efficacy as a KMO inhibitor. During the sessions, participants will be closely monitored with assessments of blood KYNA levels from enrollment to the end of the fourth session over about five weeks. Researchers will also track QUIN levels, alcohol craving, and negative mood. Safety and tolerability will be observed throughout, with the total study duration involving multiple visits for medication administration and biological sample collection to understand diclofenac's impact on KP metabolites and related behaviors in AUD.

Age: 21Years - 65YearsAll GendersPhase 1
1 location
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Actively Recruiting

Researchers are evaluating treatment preference and satisfaction among adults in the United States diagnosed with schizophrenia who are prescribed xanomeline and trospium chloride (X/T) therapy. The study aims to understand how patients feel about their medication and how satisfied they are with their treatment experience. Participants will receive xanomeline and trospium chloride (X/T) therapy according to the product label. This treatment is being observed in a real-world setting without modifications, focusing on how patients use and respond to this medication combination. During the study, participants will report their medication preference through the Preference of Medication (POM) questionnaire at Month 1, Month 3, and Month 6. Treatment satisfaction will also be measured using the Medication Satisfaction Questionnaire (MSQ) at baseline and at Months 1, 3, and 6. Participants will provide their responses either electronically or on paper, in English or Spanish, over a period of at least six months.

Age: 18Years +All Genders
18 locations
P

Actively Recruiting

Researchers are studying schizophrenia, a condition marked by ongoing inflammation that worsens symptoms like cognitive problems. This research aims to test if a special prebiotic supplement called Prebiotin®, which helps increase beneficial bacteria and their anti-inflammatory product butyrate, can reduce inflammation and improve thinking skills in people with schizophrenia or schizoaffective disorder. The study also looks at how changes in gut bacteria and inflammation relate to symptoms and metabolism. Participants will take part in a 12-week, double-blind, placebo-controlled trial where some receive Prebiotin®, a powder mixed with water that tastes slightly sweet, and others get a placebo powder mixed with water. Neither participants nor researchers will know who receives which treatment during the trial. The goal is to observe changes in blood butyrate levels, cognitive function, symptoms, and metabolic health. Throughout the study, participants will be monitored for changes in serum butyrate, cognitive abilities, and any side effects at 12 weeks. Researchers will assess symptoms, metabolic measures, and biological markers related to inflammation and gut health. The study requires participants to be clinically stable and currently using antipsychotic medication with no recent dose changes. Total participation lasts at least 12 weeks with careful evaluation of safety and treatment effects.

Age: 18Years - 60YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are evaluating a pilot clinical trial using repetitive transcranial magnetic stimulation (rTMS) in 34 people diagnosed with schizophrenia. The study aims to see if a 1 Hertz (Hz) inhibitory rTMS treatment applied to the motor cortex can increase brain inhibition, measured by a decrease in the short-interval intracortical inhibition (SICI) score. Additionally, the trial will gather early data on how rTMS might affect resting functional connectivity of the motor cortex with other brain regions and how these changes relate to cognitive performance improvements. Participants will be randomly assigned in equal numbers to receive either active 1Hz rTMS or a sham (placebo) version of the same treatment. The rTMS is delivered non-invasively to the scalp surface targeting the motor cortex over a 5-day period. The trial is double-blind, meaning neither participants nor researchers know who receives active or sham stimulation. This study focuses on assessing the feasibility and tolerability of this 5-day intervention in people with schizophrenia. During the study, participants will be evaluated before and after treatment for changes in the SICI score, brain connectivity through resting state assessments, and cognitive task performance such as stop signal reaction time and spatial working memory. Researchers will also explore relationships between these changes and clinical scales, medication use, and smoking dependence. Safety and tolerability will be monitored throughout, with the primary outcome measured one week after treatment completion.

Age: 18Years - 45YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Schizophrenia spectrum disorders affect the brain's white matter, which is important for quick communication between brain regions and is linked to cognitive difficulties, especially slower processing speed. This research explores whether training with a mock musical instrument can improve white matter structure in people with schizophrenia. The study focuses on understanding how white matter changes in response to this type of training. Participants will use a music video game called 'Guitar Hero' to learn a new skill through behavioral training. This training aims to examine changes in white matter microstructure linked to the cognitive challenges seen in schizophrenia. During the study, researchers will measure white matter microstructure after 3 weeks of training. Participants will be assessed for brain changes using MRI scans and monitored for their ability to learn the new skill. The study includes screening for eligibility and consent, with a focus on brain imaging and behavioral outcomes.

Age: 15Years - 45YearsAll GendersPhase Not Applicable
2 locations
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