Axsome Therapeutics Inc. ((AXSM)) announced an update on their ongoing clinical study.
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Study Overview: Axsome Therapeutics Inc. is conducting a study titled A Randomized, Double-blind, Active-controlled Study of AXS-05 for the Prevention of Relapse of Depressive Symptoms. The study aims to evaluate the efficacy of AXS-05 compared to bupropion in preventing the relapse of depressive symptoms in individuals with major depressive disorder (MDD) who have responded to AXS-05 treatment. This research is significant as it explores potential advancements in maintaining mental health stability for MDD patients.
Intervention/Treatment: The study tests two interventions: AXS-05, an experimental drug taken twice daily, and bupropion, an active comparator also taken twice daily. AXS-05 is intended to prevent the relapse of depressive symptoms in MDD patients.
Study Design: This is an interventional study with a randomized, parallel assignment. It employs a triple masking method, where participants, care providers, and investigators are blinded to the treatment allocations. The primary purpose is treatment-focused, aiming to assess the long-term efficacy of AXS-05.
Study Timeline: The study began on January 16, 2024, with the latest update submitted on January 21, 2025. These dates are crucial for tracking the study’s progress and ensuring timely updates on its findings.
Market Implications: The ongoing study could influence Axsome Therapeutics’ stock performance positively if AXS-05 proves effective, potentially boosting investor confidence. As the company competes in a crowded pharmaceutical market, successful results could enhance its competitive edge and market share.
The study is currently recruiting, with further details available on the ClinicalTrials portal.