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

Navitor Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Major Depressive Disorder

Treatments

Drug: NV-5138

Study type

Interventional

Funder types

Industry

Identifiers

SPN-820 (Other Identifier)

NAV-17A-008

Details and patient eligibility

About

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

Full description

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

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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.