Phase 2
Completed N=40
Open-Label of SPN-820 in Adults With Major Depressive Disorder
Source: ClinicalTrials.gov NCT06235905 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcomePrimary: Change From Baseline to Each Time Point in the Hamilton Depression Rating Scale-6 Items (HAM-D6) Total Score (HAM-D6). — -6.1; -7.2; -7.5; -7.8 score on a scale
Summary
This study will evaluate of the efficacy and safety of SPN-820 in Adults With Major Depressive Disorder (MDD)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Each Time Point in the Hamilton Depression Rating Scale-6 Items (HAM-D6) Total Score (HAM-D6). |
-6.1; -7.2; -7.5; -7.8; -8.7; -7.2 | — |
| SECONDARY Change From Baseline to Each Time Point in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score. |
-16.6; -16.6; -21.2; -21.2; -23.3; -22.9 | — |
| SECONDARY Change From Baseline to Each Time Point in the Clinical Global Impression - Severity of Illness Score (CGI-S). |
-1.5; -2.2; -2.4 | — |
| SECONDARY Suicidal Ideation and Behavior as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) |
5; 0; 2; 0; 2; 0 | — |
| SECONDARY Incidence of Treatment Emergent Adverse Events |
62.5 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT06235905). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.