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Found 4 Actively Recruiting clinical trials
Actively Recruiting
Diclofenac Dosing Study to Increase Brain Protective Metabolites in Adults with Alcohol Use Disorder
Researchers are investigating the use of diclofenac, a medication already approved for other uses, as a possible treatment for Alcohol Use Disorder AUD. The study focuses on the kynurenine pathway KP, which is disrupted by chronic alcohol use, leading to decreased levels of a protective substance called kynurenic acid KYNA and increased levels of a harmful substance called quinolinic acid QUIN. This imbalance is linked to alcohol-related problems, and diclofenac may help restore the balance by inhibiting an enzyme called kynurenine 3-monooxygenase KMO. In this phase 1 pilot study, 24 participants with AUD will attend four sessions where they will receive one of three doses of diclofenac 50 mg, 75 mg, or 100 mg or a placebo. The study uses a randomized and quadruple-blind design to compare these treatments. The goal is to find out which dose of diclofenac most effectively increases KYNA levels and to observe effects on QUIN levels, alcohol craving, and mood. Participants will be involved in four sessions over approximately five weeks. Blood samples will be collected to measure changes in KYNA levels from enrollment to the end of the study. Researchers will also evaluate participants alcohol cravings and negative mood. Safety and tolerability will be monitored throughout the study, which is sponsored by the University of Maryland, Baltimore.
Actively Recruiting
Researchers are evaluating treatment preferences and satisfaction among adults with schizophrenia in the United States who are prescribed xanomeline and trospium chloride XT therapy. This observational study aims to understand patient experiences with this therapy over time to help inform future treatment approaches. Participants in this study are adults aged 18 years or older with a confirmed diagnosis of schizophrenia who have recently received a prescription for XT therapy and plan to start the treatment. The study observes participants using this therapy according to the product label without altering their prescribed regimen. During the study, participants will provide information about their medication preference and treatment satisfaction through questionnaires at baseline, Month 1, Month 3, and Month 6. Additional data collected include treatment plans, dose changes, concomitant medications, reasons for discontinuation, and baseline clinical and demographic characteristics. Participants will use electronic devices or paper records to report outcomes, and the study will continue until May 2029.
Actively Recruiting
Researchers are studying a pilot clinical trial to evaluate repetitive transcranial magnetic stimulation rTMS in 34 people with schizophrenia. The trial aims to see if a 5-day, 1 Hertz Hz rTMS treatment targeting the motor cortex can increase brain inhibition, measured by a decrease in the short-interval intracortical inhibition SICI score. The study also explores how rTMS affects the resting functional connectivity of the motor cortex and other brain regions, as well as changes in cognitive performance. Participants with schizophrenia will be randomly assigned to receive either active 1Hz rTMS or a sham placebo version of the treatment. The rTMS involves multiple trains of stimulation each day over five days using either an active or sham device coil. This randomized, double-blind trial is designed to estimate the feasibility and tolerability of the rTMS intervention and to gather preliminary data for future research. During the study, participants will undergo assessments before and after the treatment to measure changes in SICI scores, brain connectivity, and cognitive task performance such as stop signal reaction time and spatial working memory. Additional clinical scales and medication information will be collected to explore relationships with brain inhibition changes. Safety, tolerability, and adherence will be monitored throughout the trial, which is expected to last one week for primary outcome measurement.
Actively Recruiting
Schizophrenia spectrum disorders involve damage to the white matter in the brain, which is important for quick communication between brain regions needed for complex thinking. This damage is linked to difficulties with thinking skills in schizophrenia, especially slower processing speed. The study aims to explore whether training by playing a mock musical instrument can improve white matter structure in people with these disorders. Participants will be randomly assigned to one of two groups. One group will take part in training sessions using the video game Guitar Hero to learn a new skill, while the other group will have observation training. The study will compare changes in white matter microstructure and brain levels of N-acetylaspartate over a 3-week period. Throughout the study, participants will be evaluated using brain scans and other assessments to measure changes in white matter and brain chemistry. The main outcome is the change in white matter microstructure after 3 weeks. Participants will be monitored for safety and adherence during the study, which runs from January 2025 to December 2026, with involvement lasting at least 3 weeks.