Loading clinical trials...

Open-Label of SPN-820 in Adults With Major Depressive Disorder | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT06235905•Navitor Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

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

Detailed Description

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

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Viking Clinical Research

Temecula, California, United States

Key Dates

Start Date

February 15, 2024

Primary Completion Date

August 18, 2024

Completion Date

August 18, 2024

Last Updated

October 21, 2025

Enrollment

ACTUAL participants

Conditions

Major Depressive Disorder

Interventions

NV-5138

DRUG

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

NCT07115329

Major Depressive Disorder

View study

RECRUITINGPHASE3

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

NCT06793397

Major Depressive Disorder (MDD)Depression in Adults+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk

Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment

University of Iowa Interventional Psychiatry Service Patient Registry

Preliminary Efficacy Trial of a Digital Intervention for Depression and Cannabis Use