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NCT05419869 · ClinicalTrials.gov registry record · Phase 2
Pilot Decentralized Trial
A Phase 2 study of Major Depressive Disorder, sponsored by Alto Neuroscience.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 2
- Study locations
NCT05419869: Completed Phase 2 study of Major Depressive Disorder, sponsored by Alto Neuroscience.
NCT05419869 is a Phase 2 study of Major Depressive Disorder that has completed, run by Alto Neuroscience. The registered enrollment target is 21 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (94% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05419869, a Phase 2 study of Major Depressive Disorder, has completed, sponsored by Alto Neuroscience.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to collect biologically-based data for defining predictors and correlates of the effects of ALTO-100.
Primary Outcome
The Montgomery-Åsberg Depression Rating Scale (MADRS) measures the severity of depression where smaller scores indicate less depression and higher scores suggest more severe depression. Possible scores for this 10 item version range from 0 to 60. The score change from the start of dosing (Day 1) to the end of treatment (Day 56) is the primary outcome.
Conditions Studied
Interventions
- DRUG ALTO-100 PO Tablet
Study Locations (2)
Florida
- Site 160 - Coral Gables
Mississippi
- Site 156 - Jackson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2022-06-01 |
| Est. Completion | 2023-01-26 |
| Phase | Phase 2 |
What the finished NCT05419869 record still lists
NCT05419869 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 1 intervention - of which ALTO-100 PO Tablet is the first listed.
NCT05419869 reports a single indexed study location in Florida, Mississippi.
Frequently Asked Questions
What is clinical trial NCT05419869 about?
NCT05419869 is a clinical study titled "Pilot Decentralized Trial". The purpose of this study is to collect biologically-based data for defining predictors and correlates of the effects of ALTO-100.
What is the current status of trial NCT05419869?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2022-06-01. Estimated completion is 2023-01-26.
What conditions does trial NCT05419869 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT05419869?
The interventions under investigation include: ALTO-100 PO Tablet (DRUG).
Who is sponsoring clinical trial NCT05419869?
This trial is sponsored by Alto Neuroscience, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05419869 being conducted?
This trial has 2 study locations across Florida, Mississippi. 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 NCT05419869's enrollment target sits among peer trials
21 240th of 282 higher than 41 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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