Clinical trial NCT06235905: Open-Label of SPN-820 in Adults With Major Depressive Disorder
Official title: An Open-Label, Single-Group Study to Evaluate the Efficacy and Safety of SPN-820 in Adults With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: Navitor Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Supernus Pharmaceuticals, Inc.
First posted: 2024-02-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Evaluation of the efficacy of SPN-820 administered once every 3 days as measured by the Hamilton Depression Rating Scale-6 Items
timeFrame: 10 days
Secondary outcomes:
measure: Evaluation of the efficacy as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) score
timeFrame: 10 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Muhammad Saleem Ismail
state: New York
Study officials:
References: