At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 250 enrolled
Drug / intervention
NV-5138 +1 moredrug
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.
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
In Brief
A Phase 2 clinical trial evaluating NV-5138 and matched placebo for Treatment Resistant Depression. Completed, enrolled 250 participants across 1 site.
Detailed Summary
This study will evaluate the efficacy and safety of NV-5138 in adults with TRD
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTreatment Resistant Depression
CountriesUnited States
CollaboratorsSupernus Pharmaceuticals, Inc.
Timeline
Phase 2CompletedFinished
20222023202420252026
First PostedOct 2021
Enrollment StartJan 2022
Primary CompletionJan 2025
TodayJul 2026
First PostedOct 4, 2021
Enrollment StartJan 18, 2022
Primary CompletionJan 21, 2025
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 4.7 years ago
Interventions
NV-5138drug
NV-5138 is a novel, orally bioavailable, selective, direct enhancer of mTORC1 cellular signaling
matched placebodrug
matched placebo oral capsules