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

Launched by NAVITOR PHARMACEUTICALS, INC. · Jan 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called SPN-820 for adults with Major Depressive Disorder (MDD). The goal is to see how effective and safe this treatment is for people who are experiencing significant depression. The trial is currently recruiting participants who are between the ages of 18 and 65 and have been diagnosed with MDD. To qualify, individuals must have a certain level of depression as measured by specific rating scales and have been on a stable dose of certain antidepressant medications for at least four weeks before joining the study.

Participants in this trial can expect to be closely monitored by healthcare professionals throughout the study. They will receive the investigational treatment and will be assessed regularly to track their mood and any side effects. It's important to note that individuals with certain conditions, such as a history of psychotic disorders, severe suicidal thoughts, or substance use disorders, will not be eligible to participate. This study aims to provide valuable information about SPN-820 and its potential role in treating MDD, which could help improve future treatment options for those suffering from this condition.

Gender

ALL

Eligibility criteria

• 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 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 ≥4 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.
• • 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 2 years before screening; a history of suicide attempt in the last 6 months; 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.