Saint Charles

This trial investigates the effects of Fasedienol Nasal Spray in adults aged 18 to 65 with Social Anxiety Disorder SAD triggered by a public speaking challenge. It is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study aiming to assess the safety, tolerability, and effectiveness of repeated intranasal doses of Fasedienol to relieve acute anxiety symptoms in a clinical setting. Participants will be randomly assigned to one of three groups one receiving a dose of Fasedienol followed by a placebo spray, another receiving two doses of Fasedienol, and a third receiving two doses of placebo spray. The sprays are administered twenty minutes before the public speaking challenge, with ten minutes between doses. Those who complete this phase may enter an open-label extension where they can use Fasedienol as needed, up to six times daily for up to 12 months to assess longer-term safety and tolerability. During the study, participants will undergo assessments including the Subjective Units of Distress Scale SUDS, Clinical Global Impression of Improvement CGI-I, and Patient Global Impression of Change PGI-C over seven days. Researchers will monitor symptoms of anxiety, safety, and tolerability through clinical evaluations. The total participation timeline includes initial treatment and possible extended use with ongoing observation until the study ends in December 2026.

This research aims to evaluate how human lactoferrin combined with low-dose iron affects iron levels, aerobic fitness, and lactate metabolism in women who exercise and have low iron stores. The study focuses on healthy menstruating women aged 18 to 45 years with serum ferritin below 35 gL, aiming to understand if lactoferrin can improve iron regulation and exercise outcomes. Iron deficiency is common in active women and can reduce oxygen delivery and exercise performance, making this study important for finding better supplementation methods. Participants will be randomly assigned to one of three groups for an 8-week period receiving 100 mg lactoferrin plus 5 mg iron daily, 300 mg lactoferrin plus 5 mg iron daily, or a placebo plus 5 mg iron daily. The study uses a triple-blind design where neither participants nor researchers know who receives which treatment. The intervention is oral supplementation taken daily, and participants will attend six visits including screening, baseline, and follow-ups at weeks 2, 4, 6, and 8. During the study, participants will undergo blood tests to measure iron biomarkers and blood parameters, along with assessments of aerobic capacity using treadmill tests measuring VO2peak, time to exhaustion, and blood lactate levels. Questionnaires will evaluate gastrointestinal symptoms, menstrual symptoms, quality of life, and recovery perception. Daily supplement adherence and any side effects will be monitored throughout. The primary outcome is the change in serum ferritin concentration over time, while secondary measures include changes in hemoglobin, hematocrit, red blood cell count, and exercise performance indicators.

Researchers are evaluating azetukalner as a treatment for adults diagnosed with moderate-to-severe Major Depressive Disorder MDD. This Phase 3, randomized, double-blind, placebo-controlled study aims to assess the clinical efficacy, safety, and tolerability of azetukalner when taken alone. The study involves participants aged 18 to 74 who have experienced their first major depressive episode before age 50. Participants receive either azetukalner 20 mg or a placebo orally once a day with food, preferably with the evening meal, for a total of 6 weeks. The study includes two groups one taking azetukalner and the other taking placebo, both under blinded conditions to ensure unbiased results. During the study, participants will be regularly monitored through clinical evaluations, including changes in depression severity scores such as the Hamilton Depression Rating Scale HAMD-17 and other scales measuring pleasure and clinical global impression. Safety and tolerability will be observed from screening through 8 weeks after the final dose. The total study duration includes screening, 6 weeks of treatment, and post-treatment safety follow-up.

This research aims to evaluate the safety and effectiveness of Icalcaprant in adults diagnosed with bipolar I or II disorder, specifically focusing on depressive episodes. Bipolar disorder is a chronic mood condition affecting a significant portion of the adult and pediatric populations in the United States. The study targets approximately 195 adult participants across about 35 sites in the U.S., aiming to understand how Icalcaprant impacts disease activity and adverse events. Participants are randomly assigned to one of three groups two groups receive different doses of oral Icalcaprant once daily for 6 weeks, and one group receives a matching placebo daily for the same period. After the treatment phase, all participants enter a 4-week safety follow-up period. The study uses a parallel design with quadruple masking to compare the effects of the investigational drug versus placebo. During the study, participants will attend regular visits at hospitals or clinics where they undergo medical assessments, blood tests, and complete questionnaires to monitor side effects and treatment effects. Researchers will measure changes from baseline to week 6 in depression severity using the Montgomery-sberg Depression Rating Scale and the Clinician Global Impression of Severity for bipolar disorder. Safety will be monitored up to approximately 10 weeks, ensuring participant well-being throughout the trial.

Researchers are evaluating the efficacy, safety, and tolerability of VLS-01 buccal film VLS-01-BU in adults with treatment resistant Major Depressive Disorder TRD. This Phase 2, multicenter, randomized, placebo-controlled trial aims to understand the onset and duration of antidepressant effects of VLS-01-BU compared to placebo in patients who have not responded to previous treatments. Participants will be randomly assigned to receive two doses of either VLS-01-BU or placebo administered via a buccal transmucosal film, with two weeks between doses. After a 12-week follow-up monitoring period, all participants will be re-randomized to receive one additional dose of VLS-01-BU at one of two dose strengths. Safety and efficacy will be assessed two weeks after this third dose during a non-placebo-controlled treatment phase. Throughout the study, participants depressive symptoms will be regularly monitored using the Montgomery-sberg Depression Rating Scale MADRS from baseline to Day 29 and through Day 43. The study includes multiple assessments to measure the antidepressant effects and safety of the treatment. The total duration of participant involvement covers the initial dosing, follow-up, re-randomization, and final evaluation, ensuring thorough observation of treatment impact and tolerability.

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.

This research aims to evaluate the long-term safety and explore the efficacy of astegolimab in adults aged 40 to 90 years with chronic obstructive pulmonary disease COPD. It focuses on participants who have completed a 52-week placebo-controlled treatment period in previous studies GB43311 or GB44332. The study is a phase 3, open-label extension to gather extended safety information on this drug in COPD patients. Participants from the parent studies who qualify will receive subcutaneous injections of astegolimab every two weeks throughout the study until it ends. This open-label extension allows all participants to receive the active drug without placebo comparison. The study continues treatment beyond the initial 52-week period to monitor long-term effects. During the study, participants will be monitored for adverse events up to 12 weeks after their last dose of astegolimab. Researchers will collect safety data to understand the incidence of any side effects. The study involves regular assessments and follow-ups to ensure participant well-being, with the total duration lasting until July 2034.

Researchers are evaluating ACP-211 as a monotherapy for adults aged 18 to 65 with major depressive disorder MDD who have not improved with antidepressant therapy, including treatment-resistant depression. The study aims to determine if ACP-211 reduces depression symptoms better than a placebo and to monitor any adverse events. This is a randomized, double-blind, placebo-controlled Phase 2 trial conducted by ACADIA Pharmaceuticals Inc. Participants are randomly assigned to receive either 600 mg or 300 mg of ACP-211, or a matching placebo, all administered orally twice weekly. The study lasts for 28 days, during which participants take their assigned capsules. The trial uses a parallel group design to compare the effects of the two ACP-211 doses against placebo. During the study, participants will undergo assessments including the Montgomery-sberg Depression Rating Scale MADRS at baseline, Day 2, and Day 28, along with other clinical evaluations such as the Clinical Global Impression-Severity CGI-S score. Researchers will track changes in depression symptoms, remission rates, and responses throughout the trial. Safety and tolerability will be monitored, and the study is expected to complete by September 2027.

Researchers are evaluating the safety and effectiveness of TSND-201 in adults diagnosed with Post Traumatic Stress Disorder PTSD who have had symptoms for at least six months. The study involves participants who have previously tried at least one medication or trauma-focused psychotherapy for PTSD. This phase 3 randomized, double-blind, placebo-controlled trial aims to compare two doses of TSND-201 capsules with a placebo to better understand treatment options for PTSD. Participants will enter a 4-week Treatment Period during which they will be randomly assigned to receive either one of two doses of TSND-201 or a placebo capsule once a week, taken orally. After completing this treatment phase, they will continue into an 8-week Follow-up Period to monitor their progress and any changes in their condition. The study uses a parallel design and masking to keep participants and researchers unaware of group assignments. During the study, participants will undergo assessments including the Clinician-Administered PTSD Scale for DSM-5 CAPS-5 to measure changes in PTSD severity from the start through 12 weeks. Researchers will also monitor safety and efficacy by evaluating participants regularly through interviews and questionnaires. The entire participation duration covers 12 weeks, including treatment and follow-up, with safety and response being closely observed throughout.

Researchers are evaluating the effects of daily geranylgeraniol GG supplementation on muscle strength, body composition, and aerobic fitness in healthy, physically active adults aged 30 to 60 years. This randomized, double-blind, placebo-controlled trial aims to understand how different doses of GG influence muscle health and related physiological markers over an 8-week period. Participants will be randomly assigned to one of three groups receiving daily doses of either a placebo olive oil, 150 mg GG, or 300 mg GG. Supplements are taken with water at a consistent time each day for 8 weeks. The study includes a screening visit and testing at baseline, week 4, and week 8 to track changes over time. During the study, participants undergo strength testing bench press and leg press, muscular endurance assessments, aerobic capacity measurement via treadmill, and body composition analysis using advanced techniques. Blood samples will be collected to monitor metabolism-related biomarkers and safety. Participants also complete mood and quality of life questionnaires, provide dietary logs, and give fecal samples. Safety is tracked throughout, and the main outcomes focus on changes in strength and fat-free mass from start to week 8.