CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
NV-5138drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06235905
NCT06235905Phase 2Completed
CompareCT.gov

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

Navitor Pharmaceuticals, Inc.·interventional·Posted Feb 1, 2024·Updated Oct 21, 2025

In Brief

A Phase 2 clinical trial evaluating NV-5138 for Major Depressive Disorder. Completed, enrolled 40 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
CollaboratorsSupernus Pharmaceuticals, Inc.

Timeline

Phase 2CompletedFinished
202420252026
First PostedFeb 1, 2024
Enrollment StartFeb 15, 2024
Primary CompletionAug 18, 2024
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 2.4 years ago

Interventions

NV-5138drug

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