NCT06235905

Open-Label of SPN-820 in Adults With Major Depressive Disorder

An Open-Label, Single-Group Study to Evaluate the Efficacy and Safety of SPN-820 in Adults With Major Depressive Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Navitor Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate of the efficacy and safety of SPN-820 in Adults With Major Depressive Disorder (MDD)

Detailed description

This is an open-label study of adjunctive SPN-820 (2400 mg) administered orally once every 3 days in adults with MDD

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	NV-5138	NV-5138 is a novel, orally bioavailable, mechanistic target of rapamycin complex 1 (mTORC1) signaling enhancer

Timeline

• Start date: 2024-02-15
• Primary completion: 2024-08-18
• Completion: 2024-08-18
• First posted: 2024-02-01
• Last updated: 2025-10-21
• Results posted: 2025-10-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study