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NCT05922878 · ClinicalTrials.gov registry record · Phase 2
Study of ALTO-300 in MDD
A Phase 2 study of Major Depressive Disorder, sponsored by Alto Neuroscience.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 321
- Enrollment target
- 20
- Study locations
NCT05922878: Recruiting Phase 2 study of Major Depressive Disorder, sponsored by Alto Neuroscience.
NCT05922878 is a Phase 2 study of Major Depressive Disorder that is actively recruiting participants, run by Alto Neuroscience. The registered enrollment target is 321 participants, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (15% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05922878, a Phase 2 study of Major Depressive Disorder, is actively recruiting participants, sponsored by Alto Neuroscience.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 321 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine efficacy differences between ALTO-300 and placebo, used adjunctively to an antidepressant, related to patient characteristics.
Primary Outcome
MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ALTO-300
Study Locations (20)
California
- Site 218 - Bellflower
- Site 217 - Glendale
- Site 335 - Lafayette
- Site 209 - Los Angeles
- Site 219 - Mather
- Site 194 - Mission Viejo
- Site 197 - Temecula
Florida
- Site 159 - Clermont
- Site 225 - Miami Gardens
- Site 190 - Miami Lakes
- Site 161 - Okeechobee
- Site 221 - Tampa
- Site 220 - West Palm Beach
Arizona
- Site 200 - Phoenix
- Site 189 - Phoenix
- Site 187 - Yuma
Colorado
- Site 203 - Colorado Springs
- Site 349 - Evergreen
Arkansas
- Site 193 - Rogers
Connecticut
- Site 214 - Norwalk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 321 participants |
| Start Date | 2023-06-08 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
What NCT05922878 shows while recruiting
NCT05922878 is an interventional study that assigns participants to a tested intervention. The registered 321 participants enrollment target is mid-sized for trials with a published cap, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (15% lower).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05922878 names 20 study sites across 6 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT05922878 about?
NCT05922878 is a clinical study titled "Study of ALTO-300 in MDD". The purpose of this study is to determine efficacy differences between ALTO-300 and placebo, used adjunctively to an antidepressant, related to patient characteristics.
What is the current status of trial NCT05922878?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 321 participants. The study started on 2023-06-08. Estimated completion is 2026-12.
What conditions does trial NCT05922878 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT05922878?
The interventions under investigation include: Placebo (DRUG), ALTO-300 (DRUG).
Who is sponsoring clinical trial NCT05922878?
This trial is sponsored by Alto Neuroscience, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05922878 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05922878's enrollment target sits among peer trials
321 52nd of 282 higher than 231 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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