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

NCT05066672 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-04-17

Study results available
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Summary

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

Conditions

Interventions

DRUG

NV-5138

NV-5138 is a novel, orally bioavailable, selective, direct enhancer of mTORC1 cellular signaling

DRUG

matched placebo

matched placebo oral capsules

Sponsors & Collaborators

  • Supernus Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Navitor Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas Laage, MD · Medical Monitor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-18
Primary Completion
2025-01-21
Completion
2025-01-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05066672 on ClinicalTrials.gov