Life sciences · Phase 2 Trial
ClinicalTrials.gov · September 18, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT06236880). This is a study registration, not published results. Lead sponsor: Gilgamesh Pharmaceuticals. Recruitment status: COMPLETED. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 126 participants (ACTUAL). Conditions: Major Depressive Disorder. Interventions: DRUG: GM-2505. Primary outcome measures: Safety and Tolerability (Part A, B, and C) , 99 Days; MADRS Score (Part B and C) , 29 Days. Brief summary: This is a three-part Phase 2a study. The aim of Part A is to assess the safety and tolerability and preliminary antidepressant efficacy in patients with MDD who are not currently on an antidepressant therapy. The aim of Part B is to assess the antidepressant efficacy, safety and tolerability in patients with MDD who are partial responders while on a current and adequate single SSRI or SNRI treatment. Part C aims to replicate the monotherapy findings of Part A, but with a lower control group dose.