Could a Brain-Boosting pill lift depression?
NCT ID NCT06235905
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tested an experimental oral drug called SPN-820 in 40 adults with major depressive disorder. The drug aims to enhance a key brain signaling pathway (mTORC1) that may help improve mood. Researchers measured changes in depression scores over time to see if the drug is safe and effective.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SPN-820 (also called NV-5138), an oral drug that boosts a brain signaling pathway
- What this could lead to
- If it works, this could point toward a new oral treatment for major depression that acts quickly on brain cell signaling.
- What could go wrong
- This was a small, early-phase trial with only 40 people and no placebo group, so results may not be reliable or apply to everyone. Depression symptoms can also improve on their own.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
40 people
The number who actually took part.
- Started
-
Feb 2024
- Finished
-
Aug 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Viking Clinical Research
Temecula, California, 92591, United States
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