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Found 3 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the safety, tolerability, and effectiveness of CYB003, a Deuterated Psilocin Analog, compared to a placebo when added to current antidepressant treatment in adults with moderate to severe Major Depressive Disorder (MDD). This Phase III trial focuses on participants aged 18 to 85 years who have had inadequate response to a stable antidepressant dose, aiming to better understand how CYB003 might improve depressive symptoms. Participants receive oral doses of CYB003 or matching placebo along with manualized psychological support provided by trained facilitators. The treatment period includes multiple dosing sessions with monitoring and assessments throughout. Placebo is used as a comparator to evaluate the combined safety and efficacy of CYB003 in this population. During the study, participants undergo evaluations using the Montgomery-Åsberg Depression Rating Scale (MADRS) at several time points, including screening, baseline, and multiple days up to the end of treatment at Day 42. Researchers monitor symptoms, side effects, and overall safety. Participants provide informed consent and are assessed regularly to track changes in depression severity and any adverse events over the course of the study.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of TSND-201 capsules for adults diagnosed with Post Traumatic Stress Disorder (PTSD). This Phase 3 trial includes participants who meet the DSM-5 criteria for PTSD with symptoms lasting at least six months and who have previously tried at least one pharmacological or trauma-focused psychotherapy treatment. The study aims to measure changes in PTSD severity using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Participants will be randomly assigned in equal groups to receive either one of two doses of TSND-201 or a placebo. These treatments are given orally once a week over a four-week Treatment Period. After completing treatment, participants will enter an eight-week Follow-up Period to monitor ongoing effects and safety. During the study, participants will complete interviews and written questionnaires to assess their PTSD symptoms and overall health. Researchers will track changes in PTSD severity up to 12 weeks from the start of treatment. Safety monitoring will include assessments to ensure participants remain free from other significant illnesses and manage any side effects. The total participation time includes the four-week treatment and eight-week follow-up phases.
Actively Recruiting
Researchers are evaluating the effectiveness of ALTO-300 compared to a placebo when added to an antidepressant treatment in adults with moderate to severe major depressive disorder (MDD). This Phase 2 study aims to identify differences in how well ALTO-300 works based on patient characteristics. The main goal is to measure changes in depression symptoms over six weeks using the Montgomery-Åsberg Depression Rating Scale (MADRS). Participants will receive either ALTO-300 capsules or placebo capsules once daily while continuing their current antidepressant, which must be a single SSRI, SNRI, or bupropion taken for at least six weeks without recent dose changes. The study includes a randomized, double-blind phase where neither participants nor researchers know who receives the active drug or placebo. There is also an open-label extension phase after the initial treatment period. During the study, participants will undergo regular assessments to monitor their depression symptoms and overall health. Researchers will track changes in MADRS scores up to week 6 to evaluate treatment effects. Participants must comply with all study procedures, and safety will be closely monitored throughout the trial. The study includes adults aged 18 to 70 years who meet the specific inclusion criteria and do not have any exclusion conditions.