Skip to main content
OpenTrials
Completed

NCT Number: NCT06235905

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Viking Clinical Research

Temecula, California, 92591, United States

About this study

This is an open-label study of adjunctive SPN-820 (2400 mg) administered orally once every 3 days in adults with MDD

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

NV-5138

Drug

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

Other names: SPN-820

Primary outcomes

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

    Time frame: 10 days (end of study)

    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.

Secondary outcomes

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

    Time frame: 10 days (end of study)

    MADRS is a 10-item scale (Reported sadness, Apparent sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimist thoughts, and Suicidal thoughts) where each item is scored from 0 to 6. The total score is the sum of the 10 items ranging from 0 to 60 where higher scores indicate more severe depression, and lower scores are better outcomes.

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

    Time frame: 10 days (end of study)

    CGI-S is a single-item clinician rating of the clinician's assessment of the severity of symptoms in relation to the clinician's total experience with patients with that condition. The CGI-I is rated on a 7-point scale from 1 to 7, where 1 = "normal not at all ill" and 7 = "among the most extremely ill patients". Successful therapy is indicated by a lower overall score.

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

    Time frame: 10 days (end of study)

    C-SSRS assessment included "yes" or "no" responses for 5 questions, each related to suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan) and suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, suicide). Number of participants with a response of 'yes' to any suicidal ideation or suicidal behavior item as measured by C-SSRS is reported.

  4. Incidence of Treatment Emergent Adverse Events

    Time frame: 10 days (end of study)

    The incidence of treatment-emergent adverse events (TEAEs) was measured as the percent of participants who took at least one dose of SPN-820 and reported at least one adverse event during 10 days of adjunct treatment. The percent is calculated by dividing "the number of participants who reported at least one Adverse Event" by "the number of participants in the Safety Population" and then multiplying the product by 100. The higher the percent, the higher the incidence.

Sponsors and collaborators

Lead sponsor

Navitor Pharmaceuticals, Inc.

Industry

Collaborators

  • Supernus Pharmaceuticals, Inc.

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 1, 2024
Registry last updated
Oct 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.