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

NCT ID: NCT05066672

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-28
• Study Completion Date: 2025-02-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

NV-5138 400 mg oral capsules

Either 2 or 4 400 mg oral capsules administered once daily

Group Type: EXPERIMENTAL

NV-5138

Intervention Type: DRUG

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

matched placebo

2 or 4 oral capsules administered once daily

Group Type: PLACEBO_COMPARATOR

matched placebo

Intervention Type: DRUG

matched placebo oral capsules

Interventions

NV-5138

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

Intervention Type: DRUG

matched placebo

matched placebo oral capsules

Intervention Type: DRUG

Other Intervention Names

SPN820; placebo; PBO

Eligibility Criteria

Inclusion Criteria

• Male or female, aged 18 to 70 years at Screening.
• Diagnosis of Major Depressive Disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) for either recurrent or single episode MDD without psychotic features that is confirmed by the Mini International Neuropsychiatric Interview (MINI).
• Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≥26 for the current MDE at all Screening visits and Baseline (Day 1).
• CGI-S score of ≥4 (moderately ill or worse) at all Screening visits and Baseline.
• History of inadequate response to ≥2 but ≤4 prior ADT therapies (including the current ADT for the current MDE) ≥ 2 weeks at Screening and ≥ 8 weeks at Baseline.
• Stable therapeutic dose of one of the following ADTs for the current MDE for ≥2 weeks prior to Screening and maintain the therapeutic dose throughout the study: citalopram, escitalopram, paroxetine, fluoxetine, sertraline, duloxetine, venlafaxine (IR or XR), desvenlafaxine, or vortioxetine.
• Detectable blood level of the approved ADT at Visits 1 and 2 of the Screening Period.

Exclusion Criteria

• MADRS Total Score improvement of ≥25% from the highest to the lowest score at any visit during the Screening Period.
• Clinically significant abnormal laboratory profiles, vital signs, or electrocardiograms (ECGs), per Investigator judgment.
• Judged by the Investigator to be at significant risk for suicide, violence, or homicide; or answers 'Yes' to items 4 or 5 on the Suicidal Ideation section of the C-SSRS at Screening or at Baseline; or has attempted suicide within the 6 months prior to Screening.
• History of psychotic disorder, including but not limited to schizophrenia, MDD with psychotic features, or bipolar I/II disorder with psychotic features.
• History of PTSD, OCD, panic disorder, intellectual disability, autism, acute stress disorder, or Cluster A or B personality disorder (per DSM-5 criteria).
• Any condition or procedure that may interfere with the absorption, metabolism, or elimination of the study medication (e.g., cholecystectomy or gastric bypass).
• In the Investigator's opinion, is unlikely to comply with the protocol or is unsuitable for any other reason.
• History of alcohol and/or substance use disorder within 6 months prior to Screening or is currently using or has positive results at Screening for drugs of abuse or has a positive alcohol result at any Screening or Baseline visit.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Supernus Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Navitor Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Randy Owen, MD

Role: STUDY_DIRECTOR

Medical Monitor

Locations

Northwest Clinical Research Center, Inc.

Bellevue, Washington, United States

Countries

United States

Other Identifiers

SPN820

Identifier Type: OTHER

Identifier Source: secondary_id

NAV-17A-007

Identifier Type: -

Identifier Source: org_study_id