NCT06400121

Apimostinel + Automated Neurocognitive Training for Depression

Phase 2, Randomized, Double-Blind, Placebo-Controlled, Single Intravenous Dose, Parallel Efficacy Study of Apimostinel With or Without Subsequent Automated Self-Association Training in Subjects With Major Depressive Disorder

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Rebecca Price · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Apimostinel shows initial promise as a novel rapid-acting antidepressant medication with minimal side effects or safety concerns. Cognitive Training (CT) is a digital intervention that has shown promise in extending the durability of another similar drug (ketamine). This randomized controlled trial will test the efficacy and safety of apimostinel (vs. placebo) for the acute treatment of depression, and will test the potential of CT to enhance and/or extend the durability of apimostinel's antidepressant effect.

Conditions

• Depression

Interventions

Type	Name	Description
DRUG	Apimostinel Infusion, Intravenous	Single injection of Apimostinel (10mg)
BEHAVIORAL	Cognitive Training	8 sessions of digital active training
BEHAVIORAL	Sham Training	8 sessions of digital sham training
DRUG	Isotonic Solution, Intravenous	Single injection of placebo

Timeline

• Start date: 2024-10-28
• Primary completion: 2029-03-01
• Completion: 2029-12-01
• First posted: 2024-05-06
• Last updated: 2025-09-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study