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NCT05712187 · ClinicalTrials.gov registry record · Phase 2
Phase 2b Study of ALTO-100 in MDD
A Phase 2 study of Major Depressive Disorder, sponsored by Alto Neuroscience.
- Completed
- Registry status
- Phase 2
- Development phase
- 301
- Enrollment target
- 20
- Study locations
NCT05712187: Completed Phase 2 study of Major Depressive Disorder, sponsored by Alto Neuroscience.
NCT05712187 is a Phase 2 study of Major Depressive Disorder that has completed, run by Alto Neuroscience. The registered enrollment target is 301 participants, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (20% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05712187, a Phase 2 study of Major Depressive Disorder, has completed, sponsored by Alto Neuroscience.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 301 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine efficacy differences between ALTO-100 and placebo, used either as monotherapy or 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-100
Study Locations (20)
California
- Site 141 - Costa Mesa
- Site 118 - Fresno
- Site 181 - Imperial
- Site 182 - Oceanside
- Site 188 - Oceanside
- Site 179 - Rancho Cucamonga
- Site 116 - Sacramento
Florida
- Site 186 - Brooksville
- Site 204 - Jacksonville
- Site 205 - Orlando
- Site 212 - Tampa
- Site 213 - Tampa
Alabama
- Site 174 - Birmingham
- Site 173 - Huntsville
Arizona
- Site 136 - Chandler
Arkansas
- Site 139 - Little Rock
Colorado
- Site 185 - Centennial
Indiana
- Site 137 - Carmel
Maryland
- Site 151 - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 301 participants |
| Start Date | 2023-01-10 |
| Est. Completion | 2024-10-24 |
| Phase | Phase 2 |
What the finished NCT05712187 record still lists
NCT05712187 is an interventional study that assigns participants to a tested intervention. The registered 301 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 (20% 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.
NCT05712187 names 20 study sites across 9 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT05712187 about?
NCT05712187 is a clinical study titled "Phase 2b Study of ALTO-100 in MDD". The purpose of this study is to determine efficacy differences between ALTO-100 and placebo, used either as monotherapy or adjunctively to an antidepressant, related to patient characteristics.
What is the current status of trial NCT05712187?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 301 participants. The study started on 2023-01-10. Estimated completion is 2024-10-24.
What conditions does trial NCT05712187 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT05712187?
The interventions under investigation include: Placebo (DRUG), ALTO-100 (DRUG).
Who is sponsoring clinical trial NCT05712187?
This trial is sponsored by Alto Neuroscience, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05712187 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. 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 NCT05712187's enrollment target sits among peer trials
301 55th of 282 higher than 228 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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