Study of ALTO-300 in MDD

NCT05922878 · tracked via the Priya Life Science USA tracker

Sponsor

Alto Neuroscience

Phase

Phase 2

Started

2023-06-08

Last updated

2025-07-24

Condition(s) studied

Major Depressive Disorder

Investigational drug(s) / intervention(s)

ALTO-300Placebo

ALTO-300: ALTO-300 capsule QD

Placebo: Placebo capsule QD

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Inclusion Criteria: * Have a diagnosis of moderate to severe major depressive disorder (MDD) * At Visit 1, currently taking a single SSRI, SNRI, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks by Visit 2 * Willing to comply with all study assessments and procedures * Must not be pregnant or breastfeeding at time of enrollment or throughout study Exclusion Criteria: * Evidence of unstable medical condition * Nightly use of sleep medication * Diagnosed bipolar disorder, psychotic disorder, or dementia * Current moderate or severe substance use disorder * Has a history of hypersensitivity or allergic reaction to ALTO-300 or any of its components/excipients * Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device

Primary outcome measure(s)

To assess efficacy of adjunctive ALTO-300 versus placebo on symptoms of MDD in a pre-defined subgroup of participants as measured by the change over time up to week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS). — Change over time for up to week 6
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 of 60. Higher scores represent a more severe condition.

Trial sites (45)

Facility	City	Region	Status
Site 200	Phoenix	Arizona	Recruiting
Site 189	Phoenix	Arizona	Withdrawn
Site 187	Yuma	Arizona	Recruiting
Site 193	Rogers	Arkansas	Recruiting
Site 218	Bellflower	California	Recruiting
Site 217	Glendale	California	Recruiting
Site 335	Lafayette	California	Recruiting
Site 209	Los Angeles	California	Recruiting
Site 219	Mather	California	Recruiting
Site 194	Mission Viejo	California	Recruiting
Site 197	Temecula	California	Recruiting
Site 203	Colorado Springs	Colorado	Recruiting
Site 349	Evergreen	Colorado	Recruiting
Site 214	Norwalk	Connecticut	Recruiting
Site 159	Clermont	Florida	Recruiting
Site 225	Miami Gardens	Florida	Recruiting
Site 190	Miami Lakes	Florida	Recruiting
Site 161	Okeechobee	Florida	Recruiting
Site 221	Tampa	Florida	Recruiting
Site 220	West Palm Beach	Florida	Recruiting
Site 224	Savannah	Georgia	Recruiting
Site 208	Snellville	Georgia	Recruiting
Site 119	Boise	Idaho	Recruiting
Site 310	Chicago	Illinois	Recruiting
Site 201	Marrero	Louisiana	Terminated
Site 198	Monroe	Louisiana	Terminated
Site 215	Jackson	Mississippi	Recruiting
Site 344	Las Vegas	Nevada	Recruiting
Site 114	Albuquerque	New Mexico	Recruiting
Site 191	Rochester	New York	Terminated
Site 192	Staten Island	New York	Recruiting
Site 199	Hickory	North Carolina	Recruiting
Site 202	Cincinnati	Ohio	Recruiting
Site 195	Oklahoma City	Oklahoma	Recruiting
Site 216	Allentown	Pennsylvania	Recruiting
Site 350	Media	Pennsylvania	Recruiting
Site 352	Moosic	Pennsylvania	Recruiting
Site 102	Dallas	Texas	Withdrawn
Site 347	Fort Worth	Texas	Recruiting
Site 148	Fort Worth	Texas	Withdrawn

+ 5 more sites — see the full list on the official registry below.

More Alto Neuroscience trials in the USA

Study of ALTO-101 in Patients With Schizophrenia Recruiting

ALTO-207 in Adults With Treatment-resistant Depression (TRD) Recruiting

ALTO-100 in Bipolar Disorder With Depression (BD-D) Recruiting

Other trials for the same condition

Prediction of REsponse to Depression Interventions Using Clinical and TD-fNIRS Measurements Enrolling by invitation

Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder Recruiting

Phase III Long-term Extension Trial to Assess Safety and Efficacy of CYB003 in MDD (EXTEND) Enrolling by invitation

Open Label Optimization Study Active, not recruiting

NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05922878 on ClinicalTrials.gov ↗ ← All trials in the USA