Open-Label of SPN-820 in Adults With Major Depressive Disorder

NCT06235905 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: NAV-17A-008SPN-820
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Each Time Point in the Hamilton Depression Rating Scale-6 Items (HAM-D6) Total Score (HAM-D6).

  The HAM-D6 scale consists of 6 items: five of them (depressed mood, work and activities, feeling of guilt, anxiety, psychic, retardation) are scored on a scale of 0 to 4, and one item (somatic symptoms general) is scored on a scale 0 to 2. The total score is the sum of the 6 items ranging from 0 to 22, higher scores indicate severe depression, and lower scores are better outcomes.

  10 days (end of study)

Secondary Outcomes (4)

• Change From Baseline to Each Time Point in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score.

  10 days (end of study)

• Change From Baseline to Each Time Point in the Clinical Global Impression - Severity of Illness Score (CGI-S).

  10 days (end of study)

• Suicidal Ideation and Behavior as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)

  10 days (end of study)

• Incidence of Treatment Emergent Adverse Events

  10 days (end of study)

Study Arms (1)

SPN-820 6 x 400 mg capsules

OTHER

Drug: NV-5138

Interventions

NV-5138 DRUG

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

Also known as: SPN-820

SPN-820 6 x 400 mg capsules

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subject, aged 18 to 65 years (inclusive) at screening.
• Diagnosis of 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) at screening.
• MADRS total score of ≥22 for the current major depressive episode (MDE) at screening and baseline (day 1) before study medication (SM) administration.
• CGI-S score of ≥4 (moderately ill or worse) at screening and baseline (day 1) before SM administration.
• Stable, therapeutic dose of one of the following protocol-defined ADTs for the current MDE for ≥6 weeks prior to screening: citalopram, escitalopram, paroxetine, fluoxetine, sertraline, duloxetine, venlafaxine (immediate release or extended release), desvenlafaxine, vilazodone, levomilnacipran, vortioxetine, bupropion, or dextromethorphan/bupropion.
• Stable therapeutic dose of the approved ADT throughout the study.

You may not qualify if:

• MADRS total score improvement of ≥25% from the highest to the lowest score from screening to baseline.
• Clinically significant abnormal laboratory profiles, vital sign measurements, or ECGs prior to baseline.
• Lifetime history of psychotic disorder, including but not limited to schizophrenia, MDD with psychotic features, or bipolar I/II disorder with and without psychotic features.
• Diagnosis within the last 12 months before screening or current diagnosis of PTSD, OCD, panic disorder, acute stress disorder, or has a history of intellectual disability, autism, or cluster A or B personality disorder.
• Suicidal behavior or suicidal ideation of type 4 or type 5 based on the C-SSRS in the 1 year before screening; a history of suicide attempt in the last 2 years; or more than 2 lifetime suicide attempts.
• History of substance use disorder within 6 months prior to screening or is currently using or has a positive result (urine drug screen) at screening or baseline for drugs of abuse.
• History of alcohol use disorder within 6 months prior to screening.
• In the investigator's opinion, is unlikely to comply with the protocol or is unsuitable for any other reason.

Sponsors & Collaborators

• Navitor Pharmaceuticals, Inc.: lead
• Supernus Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Viking Clinical Research

Temecula, California, 92591, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

NV-5138

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Senior Director Clinical Development
• Organization: Navitorpharma

gceresoliborroni@supernus.com

3018382521

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 1, 2024
• Study Start: February 15, 2024
• Primary Completion: August 18, 2024
• Study Completion: August 18, 2024
• Last Updated: October 21, 2025
• Results First Posted: October 21, 2025

Record last verified: 2025-10

Locations

US (1)