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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06235905
• Other study ID #: NAV-17A-008
• Secondary ID: SPN-820
• Status: Recruiting
• Phase: Phase 2
• Start date: February 15, 2024
• Est. completion date: October 15, 2024

Study information

• Verified date: January 2024
• Source: Navitor Pharmaceuticals, Inc.
• Contact: Gianpiera Ceresoli-Borroni, PhD
• Phone: 3018382521
• Email: gceresoliborroni[@]supernus.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 15, 2024
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• NV-5138
NV-5138 is a novel , orally bioavailable, activator of mTORC1

Locations

Country	Name	City	State
United States	Muhammad Saleem Ismail	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
Navitor Pharmaceuticals, Inc.	Supernus Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the efficacy of SPN-820 administered once every 3 days as measured by the Hamilton Depression Rating Scale-6 Items	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.	10 days
Secondary	Evaluation of the efficacy as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) score	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.	10 days