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RecruitingPhase 2

Study of ALTO-300 in MDD

Alto Neuroscience · NCT05922878

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–70 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
325
US sites recruiting
30
Study start
June 8, 2023
Record last updated
October 26, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: ALTO-300; Placebo

Conditions: Major Depressive Disorder

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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

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

Recruiting US locations

Study contacts (from the official record)

  • Alto Neuroscience · 650-200-0412 · clinical@altoneuroscience.com
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Study of ALTO-300 in MDD (NCT05922878) | Bored Studies