NCT05066672

Phase 2 Study of NV-5138 in Adults With Treatment Resistant Depression

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NV-5138 in Adults With Treatment Resistant Depression

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Navitor Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of NV-5138 in adults with TRD

Detailed description

The is a multicenter, randomized, double-blind, flexible- dose, placebo-controlled, parallel design of adjunctive NV-5138 in adults with TRD.

Conditions

• Treatment Resistant Depression

Interventions

Type	Name	Description
DRUG	NV-5138	NV-5138 is a novel, orally bioavailable, selective, direct enhancer of mTORC1 cellular signaling
DRUG	matched placebo	matched placebo oral capsules

Timeline

• Start date: 2022-01-18
• Primary completion: 2025-01-21
• Completion: 2025-01-21
• First posted: 2021-10-04
• Last updated: 2026-04-17
• Results posted: 2026-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study