Saint Charles

Researchers are evaluating a new treatment for adults aged 18 to 65 who have Social Anxiety Disorder triggered by public speaking. This Phase 2 clinical trial in the U.S. aims to study the effects, safety, and tolerability of repeated doses of Fasedienol Nasal Spray given intranasally. The study focuses on how well this treatment relieves acute anxiety symptoms caused by a public speaking challenge in a controlled clinical environment. Those who complete the initial study may also join an open-label extension to assess long-term safety and tolerability when using the nasal spray as needed for up to 12 months. Participants will be assigned to one of three groups receiving nasal spray doses 20 minutes before their public speaking challenge. One group gets two doses of Fasedienol Nasal Spray spaced 10 minutes apart, another group gets one dose of Fasedienol followed by a placebo dose, and the last group receives two placebo doses. The study compares these dosing schedules to see which best relieves anxiety symptoms. In the extension phase, eligible participants can use 3.2 micrograms of Fasedienol Nasal Spray up to six times daily for a year to monitor longer-term effects. During the study, participants will undergo clinical evaluations including anxiety rating scales and distress measurements before and after treatment. Researchers will assess responses to the public speaking challenge and monitor safety through physical exams and laboratory tests. The main outcome measured is the Subjective Units of Distress Scale over seven days between visits. Safety, tolerability, and symptom relief will be closely tracked throughout both the initial and extension phases, which together may last up to 12 months for some participants.

Researchers are evaluating the safety and effectiveness of fixed dose combinations of ensifentrine with two different doses of glycopyrrolate compared to placebo and each drug alone in adults with chronic obstructive pulmonary disease (COPD). This phase IIb study focuses on measuring lung function improvements using bronchodilator effects in people with COPD. Participants have a history of smoking and meet specific lung function criteria to be included. Participants will be randomly assigned to one of six groups: two combination treatments of ensifentrine (3 mg) with glycopyrrolate at either 21.25 or 42.5 mcg, each drug alone as monotherapy, or placebo. All treatments are given twice daily for 28 days using a standard jet nebulizer. The study includes 1 to 2 weeks of screening, 4 weeks of treatment, followed by 1 week of follow-up. During the study, participants will undergo lung function testing at baseline and on days 1, 14, 28, and 29 to measure changes in forced expiratory volume in one second (FEV1). They will also have chest X-rays or CT scans reviewed, complete questionnaires on breathlessness, and have regular assessments to monitor safety and treatment effects. Participants must be able to use the nebulizer properly and attend all study visits over approximately 7 weeks.

Iron deficiency is a common issue among physically active women and can negatively affect oxygen transport, energy production, and exercise performance. This study evaluates whether supplementing with human recombinant lactoferrin combined with low-dose iron can improve iron levels, aerobic fitness, and lactate metabolism in exercising women with low ferritin. The trial is a randomized, double-blind, active-controlled study involving about 30 healthy, menstruating women aged 18 to 45 years with serum ferritin less than 35 g/L. Participants will be divided based on their initial ferritin levels and randomly assigned to one of three groups for eight weeks: 100 mg lactoferrin plus 5 mg iron, 300 mg lactoferrin plus 5 mg iron, or placebo plus 5 mg iron daily. The study includes six visits—screening, baseline, and follow-ups at weeks 2, 4, 6, and 8. During the intervention, participants will receive daily oral supplements and be monitored for adherence and any side effects. Throughout the study, researchers will collect blood samples to measure iron biomarkers, blood components, inflammation, and metabolism. Aerobic fitness will be tested with VO2peak and treadmill time-to-exhaustion tests while tracking blood lactate levels. Participants will also report gastrointestinal and menstrual symptoms, quality of life, and recovery perceptions. The main outcome is the change in serum ferritin concentration over eight weeks, with secondary measures evaluating exercise performance and metabolic responses.

Researchers are evaluating the clinical efficacy, safety, and tolerability of azetukalner as a monotherapy in adults diagnosed with moderate-to-severe Major Depressive Disorder (MDD). This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on participants aged 18 to 74 who have experienced their first major depressive episode before age 50. The study aims to compare azetukalner with placebo in treating MDD over a 6-week period. Participants will receive either azetukalner 20 mg or placebo orally once a day with food, preferably with the evening meal, for 6 weeks. The treatment is administered as a daily oral dose, and participants are randomly assigned to one of the two groups. The study is designed to maintain blinding of treatments to both participants and researchers. During the study, participants' depression symptoms will be assessed using the Hamilton Depression Rating Scale (HAMD-17) to measure changes from baseline to Week 6. Researchers will also monitor safety and tolerability throughout the treatment period. Participants will undergo regular evaluations, and the study includes careful screening to ensure eligibility and monitor any adverse effects during the 6 weeks of treatment.

Researchers are evaluating the effectiveness and safety of SP-624 compared to a placebo in adults aged 18 to 65 with moderate to severe Major Depressive Disorder (MDD). This Phase 2B study focuses on treating this condition and assesses changes in depression severity using the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to week 4. Participants receive either SP-624 or a placebo once daily. The SP-624 treatment consists of two capsules taken orally each day, providing a total dose of 20 mg. Those in the placebo group take two matching placebo capsules daily. The study is designed as a multi-center, double-blind, randomized, placebo-controlled trial. During the study, participants will be monitored for changes in depression severity through the MADRS assessment from the start of the study to week 4. Researchers will also evaluate safety and tolerability throughout the treatment period. The total study duration and specific follow-up details are not provided but include careful observation of participants' health and response to treatment.

Bipolar disorder is a serious, long-lasting mood disorder affecting adults and children in the United States. This study evaluates the safety and effectiveness of Icalcaprant, an investigational oral medication, in adults with bipolar I or II disorder who are experiencing depressive episodes. The trial is a Phase 2, double-blind, placebo-controlled study involving about 195 adult participants across approximately 35 U.S. sites. Participants are randomly assigned to one of three groups, including a placebo group, to receive oral capsules of either Icalcaprant or placebo once daily for 6 weeks. Following treatment, there is a 4-week safety follow-up period to monitor participants' health and any side effects. The study assesses changes in depression severity using the Montgomery-Åsberg Depression Rating Scale (MADRS) and tracks any adverse events during the approximately 10-week period. Throughout the trial, participants will visit clinics or hospitals regularly for medical assessments, blood tests, and questionnaires to monitor their condition, side effects, and overall health. Researchers will measure the change in depression symptoms from baseline to Week 6 and record any adverse events up to about 10 weeks. Participants' treatment adherence and safety are closely observed during the study and follow-up periods.

Researchers are evaluating the safety, tolerability, and effectiveness of VLS-01 buccal film (VLS-01-BU) as a short-term treatment for adults with treatment resistant Major Depressive Disorder (TRD). This Phase 2, multicenter, double-blind, randomized, placebo-controlled trial aims to compare antidepressant effects of VLS-01-BU against placebo, focusing on the onset and durability of these effects. About 142 participants with TRD will be randomly assigned in equal groups to receive two doses of either VLS-01-BU or placebo via buccal transmucosal administration, spaced two weeks apart. Following this placebo-controlled period, symptoms will be monitored for 12 weeks. Then, all participants will be re-randomized to receive a single additional double-blind dose of VLS-01-BU at one of two dose strengths during a non-placebo-controlled treatment phase. Safety and efficacy will be assessed two weeks after the third dose. Participants will be closely monitored throughout the study, including during the 12-week follow-up after the second dose and after the final treatment. Researchers will measure changes in depression severity using the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to Day 29. Safety evaluations and tolerability assessments will also be conducted to understand the effects and duration of VLS-01-BU treatment.

Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of two different dose levels of solrikitug compared to placebo in people with Chronic Obstructive Pulmonary Disease (COPD). This Phase 2 study includes participants who have had COPD for at least 12 months and have elevated blood eosinophil levels. The trial aims to understand how solrikitug affects blood eosinophil counts and other health measures related to COPD. Participants will be randomly assigned to receive either low-dose solrikitug, high-dose solrikitug, or a placebo. These treatments are given by subcutaneous injection at the study site over a 12-week period. After treatment, there is a 16-week follow-up period to monitor participants for any lasting effects or safety concerns. During the study, participants will have regular assessments including lung function tests, blood tests to measure eosinophil counts, and evaluations of COPD symptoms. Researchers will monitor safety and tolerability closely throughout the treatment and follow-up periods. The total time commitment for participants covers the 12 weeks of treatment plus the 16 weeks of follow-up, totaling 28 weeks.

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 responded to treatment. This Phase 4, randomized, double-blind, active-controlled, multi-center study focuses on individuals diagnosed with MDD without psychotic features and experiencing a current major depressive episode lasting at least 4 weeks. Participants will first receive open-label AXS-05 for up to 10 weeks, during which their response and remission will be monitored. Those who meet the criteria for response and remission will then be randomly assigned to continue treatment with either AXS-05 or switch to bupropion tablets (105 mg) in a double-blind phase lasting up to 26 weeks or until relapse occurs. Throughout the study, researchers will monitor the time from randomization to relapse of depressive symptoms. Participants will undergo regular evaluations to assess their mental health status and adherence to treatment. The total participation duration includes the initial 10-week open-label period followed by up to 26 weeks in the double-blind phase, with ongoing monitoring for relapse and safety.

This research aims to evaluate the long-term safety and explore the effectiveness of astegolimab in people with chronic obstructive pulmonary disease (COPD) who have already completed a 52-week treatment in previous studies GB43311 or GB44332. The study focuses on participants aged 40 to 90 years and is a Phase III open-label extension trial designed to continue monitoring patients after their initial treatment period. Participants will receive astegolimab as a subcutaneous injection every two weeks during this extension study. This treatment continues from the prior placebo-controlled phase, allowing researchers to observe any ongoing effects and safety concerns over a longer period. The study does not include a placebo group during this extension phase, and all participants receive the active treatment. Throughout the study, researchers will closely monitor participants for any adverse events up to 12 weeks after the last dose of astegolimab. Participants will be assessed regularly to ensure their safety and to gather data on the treatment's long-term impact. The total duration of participant involvement depends on when they completed the parent studies but involves continued monitoring during and after the treatment period.