Lafayette

Researchers are evaluating a drug called DT-101 for adults with Major Depressive Disorder MDD, a form of depression. This study aims to learn if DT-101 can help treat depression when added to existing medication. The trial compares DT-101 against a placebo, which looks like the drug but contains no active medicine. Participants who qualify will be randomly assigned to receive either DT-101 or placebo for 8 weeks. During this time, they will continue their usual depression medication. The study includes physical and neurological exams, blood and urine tests, and clinical assessments to monitor safety and how the body processes DT-101. Participants will visit the clinic regularly for health checks and to complete questionnaires about their depression symptoms. Researchers will measure changes in depression severity using specific rating scales over 56 days. The study also collects data to analyze how well participants tolerate the drug and its effects on their condition.

Researchers are evaluating the effectiveness of AXS-05 compared to bupropion in preventing the return of depressive symptoms in adults with major depressive disorder MDD who have already responded to treatment with AXS-05. This is a randomized, double-blind, active-controlled study conducted across multiple centers, aiming to assess relapse prevention in people diagnosed with MDD without psychotic features. Participants will first receive open-label AXS-05 treatment for up to 10 weeks, during which their response and remission will be monitored. Those who meet response and remission criteria will then be randomly assigned to continue taking AXS-05 or switch to bupropion tablets, both taken twice daily, for a double-blind treatment period lasting up to 26 weeks or until depressive symptoms relapse. Throughout the study, participants will be closely monitored for signs of depressive symptom relapse using regular assessments. The main outcome measured is the time from randomization to relapse over the 26-week double-blind period. The entire study period includes an initial 10-week treatment phase followed by up to 26 weeks of randomized treatment, with ongoing evaluation by the study team to track safety and treatment effects.

Researchers are evaluating ALTO-300, a drug taken as a capsule once daily in the evening, for adults with moderate to severe major depressive disorder MDD. The study aims to compare the effects of ALTO-300 versus a placebo when added to an antidepressant, focusing on how patient characteristics may influence treatment outcomes. This is a randomized, double-blind trial with a phase 2 design. Participants will be randomly assigned to receive either ALTO-300 or a matching placebo capsule once daily for 42 days during the double-blind period. Those who qualify may then enter an open-label extension period lasting up to 8 weeks, during which all participants receive ALTO-300 once daily. The trial includes careful monitoring throughout both treatment periods. During the study, participants will undergo assessments to measure changes in depression symptoms using the Montgomery-sberg Depression Rating Scale MADRS up to week 6. Safety evaluations include tracking adverse events, heart rate, weight, blood pressure, and suicidality over the course of up to 15 weeks. The total participation duration may extend to 14 weeks, including both blinded and open-label phases, with regular visits and evaluations.

Researchers are studying an Acne mRNA vaccine candidate to evaluate its safety, effectiveness, and immune response in adults aged 18 to 45 years with moderate to severe acne. This first-in-human Phase III trial aims to find the best vaccine dose and regimen by testing four different doses and comparing two versus three injections. Acne is a common inflammatory skin disease, and current treatments have not changed much in 30 years, so new options are needed. The trial includes a Core Study with four cohorts two cohorts receive two doses Sentinel Cohort A and Main Cohort A and two cohorts receive three doses Sentinel Cohort B and Main Cohort B. The vaccine or placebo is given by intramuscular injection. After completing the Core Study, some participants will join a Long-Term Extension LTE follow-up lasting up to 30 months to assess lasting effects. Participants in the Main Cohort B may join a separate LTE study. During the study, participants will have medical exams, blood tests, and acne lesion counts. Researchers will monitor adverse events shortly after each injection and for up to 6 or 9 months after. They will measure changes in inflammatory and non-inflammatory acne lesions and antibody levels. Safety assessments include monitoring serious and unexpected reactions. Follow-up visits will continue for months after the last dose to observe long-term safety and immune response.