Douai

Researchers are evaluating a new approach for adults with moderate to severe ulcerative colitis who need treatment with adalimumab. This Phase IV randomized trial compares standard care with a treat-to-target strategy that includes telemonitoring and patient education. The study aims to assess the impact of using home fecal calprotectin tests and e-monitoring combined with education on disease control by week 48. All participants will initially receive adalimumab with doses starting at 1608040 mg every other week until week 14, then 40 mg every other week until week 26. Dosage may be adjusted up to 80 mg every other week or 40 mg every week based on patient or investigator choice. In addition, patients may receive azathioprine or methotrexate alongside adalimumab until week 38. The study groups differ by follow-up method one group receives standard care with doctor visits every three months, while the other group has e-monitoring, home fecal calprotectin testing, and therapy education. Participants will be involved for about 144 weeks and complete regular assessments including endoscopic exams, clinical evaluations, quality of life surveys, and treatment adherence questionnaires. The study measures success primarily by endoscopic remission at week 48 and also tracks clinical remission, healing rates, patient satisfaction, hospitalizations, colectomies, and safety. Monitoring includes frequent e-monitoring questionnaires and fecal calprotectin testing at home. The trial also evaluates medication compliance and economic outcomes related to treatment.

Drug Hypersensitivity Syndrome, also known as DRESS Drug Reaction with Eosinophilia and Systemic Symptoms, is a serious and potentially life-threatening drug allergy that can cause severe organ damage. This research focuses on understanding the role and activation of eosinophils, a type of white blood cell involved in this condition, as well as investigating the immune mechanisms behind the eosinophilia seen in DRESS patients. The study aims to compare eosinophil activation and immune cell involvement between patients with DRESS, those with drug-induced maculopapular exanthema MPE with or without eosinophilia, and healthy individuals.

Researchers are investigating how well the Clinical Global Impression Scale CGI, measured immediately after a traumatic event, predicts the development of post-traumatic stress disorder PTSD later on. This observational study focuses on patients who have experienced psychotrauma and aims to identify those at higher risk of PTSD to enable earlier and more targeted care. The study is supported by the Centre Hospitalier Arras and explores the potential of telephone follow-ups to detect and manage PTSD symptoms early. Participants receive an initial psychiatric assessment within 48 hours of a traumatic event, including questionnaires like the CGI and Peritraumatic Distress Inventory PDI. Follow-up occurs at 1 month and 6 months post-event through telephone interviews, using tools such as the PTSD Checklist Scale PCL-5 and Mini International Neuropsychiatric Interview to assess PTSD symptoms, depression, alcohol use, and substance use. This design allows researchers to correlate early CGI scores with later PTSD and related mental health outcomes. Throughout the study, participants will answer questionnaires and participate in phone assessments to monitor their mental health status over time. Researchers will analyze the data to understand how initial CGI scores relate to PTSD development and other psychological conditions. The goal is to establish a threshold CGI score that signals a need for proactive follow-up care. Participants involvement may last at least six months, with regular monitoring to support early detection and intervention for PTSD.

Researchers are conducting a multicenter, randomized, double-blind, placebo-controlled study to evaluate lumateperone as an additional treatment for adults with Major Depressive Disorder MDD who have not responded well to ongoing antidepressant therapy. The study focuses on patients diagnosed with MDD according to DSM-5 criteria, including those with psychotic features, who have experienced an inadequate response to at least two antidepressant treatments during their current major depressive episode. Participants will be randomly assigned to receive either lumateperone 42 mg capsules or matching placebo capsules taken orally once daily for six weeks during the double-blind treatment period. The trial includes three periods a screening period of up to two weeks to assess eligibility, the six-week treatment period, and a one-week safety follow-up period after the last dose to monitor participant safety. During the study, participants will undergo assessments including depression severity ratings using the Montgomery-Asberg Depression Rating Scale and the Clinical Global Impression Scale. Researchers will monitor symptoms, treatment adherence, and safety throughout the treatment and follow-up periods. Total participation spans approximately nine weeks, covering screening, treatment, and safety monitoring.