← All trial listings Recruiting

Study of ALTO-300 in MDD

ClinicalTrials.gov ID NCT05922878 · A Randomized, Double-Blind, Placebo-Controlled Study of ALTO-300 With an Open-Label Extension in Adults With Major Depressive Disorder

Check if you may qualify View the official record

At a glance

Status
Recruiting
Condition
Major Depressive Disorder
Phase
Phase 2
Ages
18 Years to 70 Years
Sex
All
Healthy volunteers
Not accepted
What is being studied
ALTO-300 (drug); Placebo (drug)
Sponsor
Alto Neuroscience
Target enrollment
321 participants
Study sites
38 open in Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Mississippi, Nevada, New Mexico, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Texas, Utah, Virginia
Start date
2023-06-08
Primary completion
2026-12

Common questions

Is NCT05922878 still recruiting?

ClinicalTrials.gov lists this trial as recruiting (checked 5 October 2026). It has 38 open or upcoming sites.

Who can take part in NCT05922878?

The record lists people aged 18 to 70 years with major depressive disorder. The study team decides who is eligible, and the full criteria are on this page and in the official record.

Where is NCT05922878 running?

38 sites in Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Mississippi, Nevada, New Mexico, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Texas, Utah, Virginia, according to ClinicalTrials.gov.

What is being studied in NCT05922878?

It is a Phase 2 trial. The record lists these interventions: ALTO-300 and Placebo. The sponsor is Alto Neuroscience.

How many people will NCT05922878 enroll?

The record gives a target of 321 participants.

How do I sign up for NCT05922878?

Use "Check if you may qualify" on this page to answer a few screening questions, or contact the study team listed on ClinicalTrials.gov.

About this trial

From the ClinicalTrials.gov record.

The purpose of this study is to determine efficacy differences between ALTO-300 and placebo, used adjunctively to an antidepressant, related to patient characteristics.

Where it's running

SiteCityStateStatus
Site 200PhoenixArizonaRecruiting
Site 187YumaArizonaRecruiting
Site 193RogersArkansasRecruiting
Site 218BellflowerCaliforniaRecruiting
Site 217GlendaleCaliforniaRecruiting
Site 335LafayetteCaliforniaRecruiting
Site 209Los AngelesCaliforniaRecruiting
Site 219MatherCaliforniaRecruiting
Site 194Mission ViejoCaliforniaRecruiting
Site 197TemeculaCaliforniaRecruiting
Site 203Colorado SpringsColoradoRecruiting
Site 349EvergreenColoradoRecruiting
Site 214NorwalkConnecticutRecruiting
Site 159ClermontFloridaRecruiting
Site 225Miami GardensFloridaRecruiting
Site 190Miami LakesFloridaRecruiting
Site 161OkeechobeeFloridaRecruiting
Site 221TampaFloridaRecruiting
Site 220West Palm BeachFloridaRecruiting
Site 224SavannahGeorgiaRecruiting
Site 208SnellvilleGeorgiaRecruiting
Site 119BoiseIdahoRecruiting
Site 310ChicagoIllinoisRecruiting
Site 215JacksonMississippiRecruiting
Site 344Las VegasNevadaRecruiting
Site 114AlbuquerqueNew MexicoRecruiting
Site 192Staten IslandNew YorkRecruiting
Site 199HickoryNorth CarolinaRecruiting
Site 202CincinnatiOhioRecruiting
Site 195Oklahoma CityOklahomaRecruiting
Site 216AllentownPennsylvaniaRecruiting
Site 350MediaPennsylvaniaRecruiting
Site 352MoosicPennsylvaniaRecruiting
Site 347Fort WorthTexasRecruiting
Site 353PlanoTexasNot yet recruiting
Site 196RichmondTexasRecruiting
Site 207ClintonUtahRecruiting
Site 211RoanokeVirginiaRecruiting
Full eligibility criteria (from the record)

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

Other recruiting trials: Depression (major depressive disorder) clinical trials · Depression (major depressive disorder) clinical trials in Texas

This listing shows only what the public ClinicalTrials.gov record NCT05922878 says, last updated there on 2025-07-24. It was checked against the registry on 5 October 2026. Taking part is voluntary, and the study team decides who is eligible. For the most current details, see the official record.