Who is eligible for clinical trial NCT05922878?

Participants must meet protocol criteria for Major Depressive Disorder. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05922878 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-07-21

Study of ALTO-300 in MDD (NCT05922878)

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Alto Neuroscience

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (7 items).

Location: Site 200 — Phoenix, Arizona

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗

Study of ALTO-300 in MDD (NCT05922878)

🩺 Plain-English Summary (8th-Grade Level)

📋 "Do I Qualify?" — 1-Minute Self Screener

Usually NOT eligible if any of the following apply:

📍 All Participating Trial Locations (45 Sites)

💰 Cost, Insurance & Patient Rights