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

Phase 2

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: NV-5138

• Registration Number: NCT06235905
• Lead Sponsor: Navitor Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2024-01-23
• Study First Submitted QC: 2024-01-23
• Study First Posted: 2024-02-01
• Study Start: 2024-02-15
• Primary Completion: 2024-08-18
• Study Completion: 2024-08-18
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SPN-820 6 x 400 mg capsules	NV-5138	-

Primary Outcome Measures

Name	Time	Method
Evaluation of the efficacy of SPN-820 administered once every 3 days as measured by the Hamilton Depression Rating Scale-6 Items	10 days	Change from baseline to each time point in the Hamilton Depression Rating Scale-6 Items (HAM-D6).; The HAM-D6 scale consists of 6 items: five of them (Depressed Mood, Self-esteem and Guilt, Social Life Activities/Interests, General Psychomotor Retardation, and Psychic Anxiety) are scored on a scale of 0 to 4, and one item (Tiredness and Pains) is scored on a scale 0-2. 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 Outcome Measures

Name	Time	Method
Evaluation of the efficacy as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) score	10 days	Change from baseline to each time point in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.; 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, better outcomes.

Trial Locations

Locations (1)

Muhammad Saleem Ismail; 🇺🇸 Rochester, New York, United States