Evaluating ALTO-300 for treating major depressive disorder

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 study aims to assess the efficacy of ALTO-300 compared to a placebo when used alongside a standard antidepressant in patients diagnosed with moderate to severe major depressive disorder (MDD). Participants must have been on a stable dose of an SSRI, SNRI, or bupropion for at least six weeks prior to enrollment. The study will analyze how patient characteristics influence the treatment outcomes. The trial is designed to provide insights into the potential benefits of ALTO-300 in enhancing depression treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• Site 200
  Phoenix, Arizona, United States Recruiting
• Site 193
  Rogers, Arkansas, United States Recruiting
• Site 218
  Bellflower, California, United States Recruiting
• Site 335
  Lafayette, California, United States Recruiting
• Site 335
  Lafayette, California, United States Recruiting
• Site 219
  Mather, California, United States Recruiting

+25 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Alto Neuroscience
• Email: clinical@altoneuroscience.com
• Phone: 650-200-0412

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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.