Anxiety & Depression Association of America

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

Purpose

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

Condition

Major Depressive Disorder

Eligibility

Eligible Ages: Between 18 Years and 65 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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.

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open-label
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Other SPN-820 6 x 400 mg capsules		Drug: NV-5138 NV-5138 is a novel , orally bioavailable, activator of mTORC1 Other names: SPN-820

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Navitor Pharmaceuticals, Inc.

Study Contact

Gianpiera Ceresoli-Borroni, PhD
3018382521
gceresoliborroni@supernus.com

Detailed Description

This is an open-label, single-group study of adjunctive SPN-820 in adults with MDD

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.