Phase 2a Study to Assess Safety, Tolerability, and Effectiveness of GM-2505 in Adults Aged 18 to 65 With Major Depressive Disorder

What this Trial Is About

Researchers are evaluating the safety, tolerability, and preliminary antidepressant effects of GM-2505 in adults with Major Depressive Disorder MDD. This Phase 2a study has three parts Part A focuses on patients not currently using antidepressants, Part B on those partially responding to a single SSRI or SNRI treatment, and Part C aims to replicate Part A findings using a lower dose control group. The study investigates how GM-2505 performs under different patient conditions and doses. The study involves administering GM-2505 through intravenous IV doses in three groups low to high dose, moderate to high dose, and a very low dose as an active comparator. Treatments are given twice at a two-week interval. Each part of the study assesses safety and antidepressant effects over specific periods, with Part B and C measuring depression scores up to 29 days and safety tracked for 99 days. Participants will undergo clinical assessments including depression rating scales such as MADRS-SIGMA at multiple time points, along with safety and tolerability evaluations. Pharmacokinetics of GM-2505 are also studied in Part C. Participants are monitored throughout the treatment and follow-up periods, with a total study duration of up to 99 days. The research team aims to understand GM-2505s effects and safety profile in different MDD patient groups.

A Phase 2a Study to Evaluate the Safety and Tolerability of GM-2505 in Patients With MDD