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NCT05922878RecruitingPhase 2

Study of ALTO-300 in MDD

A Randomized, Double-Blind, Placebo-Controlled Study of ALTO-300 With an Open-Label Extension in Adults With Major Depressive Disorder

Source: ClinicalTrials.gov · Last updated 26 Oct 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
325 (estimated)
First submitted
26 May 2023
Start date
8 Jun 2023
Primary completion date
31 Dec 2026
Lead sponsor
Alto Neuroscience
Diseases
Depression
NCT number
NCT05922878

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 325
  • From 8 Jun 2023 to the primary completion date, 31 Dec 2026
  • 74 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Nightly use of sleep medication
  • Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device

Other illness

  • Evidence of unstable medical condition
  • 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

Who the study is looking for

  • Have a diagnosis of moderate to severe major depressive disorder (MDD)
  • At Visit 1, currently taking a stable dose of 1 or 2 antidepressants (e.g., SSRI, SNRI, bupropion, or gepirone) 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

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (74)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Site 114
Coordinator of this site? Confirm its status
AlbuquerqueUnited StatesRecruiting
Site 216
Coordinator of this site? Confirm its status
AllentownUnited StatesTerminated
Site 316
Coordinator of this site? Confirm its status
AustinUnited StatesRecruiting
Site 218
Coordinator of this site? Confirm its status
BellflowerUnited StatesRecruiting
Site 317
Coordinator of this site? Confirm its status
BlackfootUnited StatesWithdrawn
Site 119
Coordinator of this site? Confirm its status
BoiseUnited StatesActive, not recruiting
Site 236
Coordinator of this site? Confirm its status
BoiseUnited StatesRecruiting
Site 318
Coordinator of this site? Confirm its status
CarlsbadUnited StatesActive, not recruiting
Site 310
Coordinator of this site? Confirm its status
ChicagoUnited StatesActive, not recruiting
Site 202
Coordinator of this site? Confirm its status
CincinnatiUnited StatesRecruiting
Site 159
Coordinator of this site? Confirm its status
ClermontUnited StatesTerminated
Site 207
Coordinator of this site? Confirm its status
ClintonUnited StatesActive, not recruiting
Site 203
Coordinator of this site? Confirm its status
Colorado SpringsUnited StatesActive, not recruiting
Site 239
Coordinator of this site? Confirm its status
ConroeUnited StatesRecruiting
Site 229
Coordinator of this site? Confirm its status
Creve CouerUnited StatesWithdrawn
Site 102
Coordinator of this site? Confirm its status
DallasUnited StatesActive, not recruiting
Site 343
Coordinator of this site? Confirm its status
DenverUnited StatesRecruiting
Site 349
Coordinator of this site? Confirm its status
EvergreenUnited StatesActive, not recruiting
Site 345
Coordinator of this site? Confirm its status
EvergreenUnited StatesActive, not recruiting
Site 277
Coordinator of this site? Confirm its status
FairfaxUnited StatesRecruiting
Site 238
Coordinator of this site? Confirm its status
FayettevilleUnited StatesRecruiting
Site 347
Coordinator of this site? Confirm its status
Fort WorthUnited StatesTerminated
Site 148
Coordinator of this site? Confirm its status
Fort WorthUnited StatesWithdrawn
Site 217
Coordinator of this site? Confirm its status
GlendaleUnited StatesActive, not recruiting
Site 279
Coordinator of this site? Confirm its status
HattiesburgUnited StatesWithdrawn
Site 199
Coordinator of this site? Confirm its status
HickoryUnited StatesActive, not recruiting
Site 275
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
Site 320
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
Site 215
Coordinator of this site? Confirm its status
JacksonUnited StatesActive, not recruiting
Site 335
Coordinator of this site? Confirm its status
LafayetteUnited StatesRecruiting
Site 344
Coordinator of this site? Confirm its status
Las VegasUnited StatesRecruiting
Site 209
Coordinator of this site? Confirm its status
Los AngelesUnited StatesActive, not recruiting
Site 240
Coordinator of this site? Confirm its status
MankatoUnited StatesRecruiting
Site 201
Coordinator of this site? Confirm its status
MarreroUnited StatesTerminated
Site 219
Coordinator of this site? Confirm its status
MatherUnited StatesRecruiting
Site 350
Coordinator of this site? Confirm its status
MediaUnited StatesWithdrawn
Site 225
Coordinator of this site? Confirm its status
Miami GardensUnited StatesActive, not recruiting
Site 190
Coordinator of this site? Confirm its status
Miami LakesUnited StatesActive, not recruiting
Site 265
Coordinator of this site? Confirm its status
MinneapolisUnited StatesRecruiting
Site 194
Coordinator of this site? Confirm its status
Mission ViejoUnited StatesTerminated
Site 206
Coordinator of this site? Confirm its status
Missouri CityUnited StatesWithdrawn
Site 198
Coordinator of this site? Confirm its status
MonroeUnited StatesTerminated
Site 267
Coordinator of this site? Confirm its status
MoorparkUnited StatesRecruiting
Site 352
Coordinator of this site? Confirm its status
MoosicUnited StatesActive, not recruiting
Site 319
Coordinator of this site? Confirm its status
New YorkUnited StatesActive, not recruiting
Site 283
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Site 214
Coordinator of this site? Confirm its status
NorwalkUnited StatesWithdrawn
Site 161
Coordinator of this site? Confirm its status
OkeechobeeUnited StatesActive, not recruiting
Site 195
Coordinator of this site? Confirm its status
Oklahoma CityUnited StatesTerminated
Site 303
Coordinator of this site? Confirm its status
Oklahoma CityUnited StatesWithdrawn
Site 231
Coordinator of this site? Confirm its status
OmahaUnited StatesActive, not recruiting
Site 200
Coordinator of this site? Confirm its status
PhoenixUnited StatesRecruiting
Site 189
Coordinator of this site? Confirm its status
PhoenixUnited StatesWithdrawn
Site 353
Coordinator of this site? Confirm its status
PlanoUnited StatesRecruiting
Site 315
Coordinator of this site? Confirm its status
ProvoUnited StatesActive, not recruiting
Site 196
Coordinator of this site? Confirm its status
RichmondUnited StatesTerminated
Site 211
Coordinator of this site? Confirm its status
RoanokeUnited StatesActive, not recruiting
Site 191
Coordinator of this site? Confirm its status
RochesterUnited StatesTerminated
Site 193
Coordinator of this site? Confirm its status
RogersUnited StatesRecruiting
Site 287
Coordinator of this site? Confirm its status
Rose HillUnited StatesRecruiting
Site 234
Coordinator of this site? Confirm its status
San MarcosUnited StatesRecruiting
Site 224
Coordinator of this site? Confirm its status
SavannahUnited StatesActive, not recruiting
Site 208
Coordinator of this site? Confirm its status
SnellvilleUnited StatesTerminated
Site 192
Coordinator of this site? Confirm its status
Staten IslandUnited StatesTerminated
Site 235
Coordinator of this site? Confirm its status
StephenvilleUnited StatesRecruiting
Site 264
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting
Site 293
Coordinator of this site? Confirm its status
Stone MountainUnited StatesNot yet recruiting
Site 221
Coordinator of this site? Confirm its status
TampaUnited StatesRecruiting
Site 197
Coordinator of this site? Confirm its status
TemeculaUnited StatesRecruiting
Site 220
Coordinator of this site? Confirm its status
West Palm BeachUnited StatesActive, not recruiting
Site 314
Coordinator of this site? Confirm its status
WichitaUnited StatesActive, not recruiting
Site 268
Coordinator of this site? Confirm its status
Winston-SalemUnited StatesRecruiting
Site 288
Coordinator of this site? Confirm its status
WorcesterUnited StatesRecruiting
Site 187
Coordinator of this site? Confirm its status
YumaUnited StatesActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.