drugset / Trial / NCT06236880
A Phase 2a Study to Evaluate the Safety and Tolerability of GM-2505 in Patients With MDD
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2024-01-31
- Primary completion
- 2026-10
- Completion
- 2026-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GM-2505 | Unknown | — | — |