ALTO-207 for adults with treatment-resistant depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial compares ALTO-207 to placebo in adults with treatment-resistant depression. Eligible participants are ages 18–75 with moderate-to-severe major depressive disorder who have failed to respond (<50% improvement) to 2–5 prior antidepressant treatments and are on a stable dose of one to two oral antidepressants. Participants at U.S. outpatient sites will receive ALTO-207 or matched placebo and depressive symptoms will be measured periodically using standard rating scales. The trial is sponsored by Alto Neuroscience and conducted at sites in Alabama and Arizona.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male and female participants, ages 18 to 75 years, inclusive, at the time of signing the ICF.
* Prior diagnosis of MDD without psychotic symptoms (in the current episode) and have confirmatory diagnosis of current MDD (moderate to severe).
* Failure to respond (\<50% improvement) to at least 2-5 antidepressant treatments (including the current treatment)
* Currently taking a stable dose of at least 1 but no more than 2 oral antidepressants at baseline

Exclusion Criteria:

* Evidence of unstable medical condition
* Concurrent use of any prohibited medications or substance use disorder
* Diagnosed bipolar disorder or a psychotic disorder or symptoms
* Significant current PTSD symptoms or history of PTSD
* Clinically significant current impulse control difficulties
* Has a history of hypersensitivity or allergic reaction to ALTO-207 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's running

• Site 7173
  Dothan, Alabama, United States Recruiting
• Site 7000
  Phoenix, Arizona, United States Recruiting
• Site 7153
  Chino, California, United States Recruiting
• Site 7069
  Los Angeles, California, United States Recruiting
• Site 7156
  Oakland, California, United States Recruiting
• Site 7082
  Oceanside, California, United States Recruiting

+13 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Alto Neuroscience
• Email: clinical@altoneuroscience.com
• Phone: 510-512-3668

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.