Study of ALTO-300 in MDD

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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

Key facts

Study ID

NCT05922878

Run by

Alto Neuroscience

People needed

321

Starts

2023-06-08

Expected to finish

2026-12-01

Last updated by the study team

2025-07-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Site 216 — Allentown, Pennsylvania, United States (enrolling)
• Site 195 — Oklahoma City, Oklahoma, United States (enrolling)
• Site 200 — Phoenix, Arizona, United States (enrolling)
• Site 350 — Media, Pennsylvania, United States (enrolling)
• Site 352 — Moosic, Pennsylvania, United States (enrolling)
• Site 347 — Fort Worth, Texas, United States (enrolling)
• Site 196 — Richmond, Texas, United States (enrolling)
• Site 207 — Clinton, Utah, United States (enrolling)
• Site 211 — Roanoke, Virginia, United States (enrolling)
• Site 187 — Yuma, Arizona, United States (enrolling)
• Site 193 — Rogers, Arkansas, United States (enrolling)
• Site 218 — Bellflower, California, United States (enrolling)
• Site 217 — Glendale, California, United States (enrolling)
• Site 335 — Lafayette, California, United States (enrolling)
• Site 209 — Los Angeles, California, United States (enrolling)
• Site 219 — Mather, California, United States (enrolling)
• Site 194 — Mission Viejo, California, United States (enrolling)
• Site 197 — Temecula, California, United States (enrolling)
• Site 203 — Colorado Springs, Colorado, United States (enrolling)
• Site 349 — Evergreen, Colorado, United States (enrolling)
• Site 214 — Norwalk, Connecticut, United States (enrolling)
• Site 159 — Clermont, Florida, United States (enrolling)
• Site 225 — Miami Gardens, Florida, United States (enrolling)
• Site 190 — Miami Lakes, Florida, United States (enrolling)
• Site 161 — Okeechobee, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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