A Phase 2a Study to Evaluate the Safety and Tolerability of Two Repeated Doses of GM-2505 at a 2-Week Interval in Patients With Major Depressive Disorder.

Official 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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 124 participants

Interventions

• DRUG: GM-2505 — IV

Primary Outcomes

• Safety and Tolerability (Part A, B, and C) (99 Days)
• MADRS Score (Part B and C) (29 Days)

Secondary Outcomes

• MADRS-SIGMA total score (Part A) (Days 14 and 29)
• MADRS-SIGMA total score (Part B and C) (All additional timepoints)
• MADRS-SIGMA total score (Part B and C) (Days 14, 29, 43, 71, and 99)
• PK of GM-2505 (Part C) (Day 16)

Trial Locations

• MAC Clinical Research, Manchester, United Kingdom

More Major Depressive Disorder Trials

View all Major Depressive Disorder clinical trials