ALTO-100 for Depression

Recruiting in Palo Alto (17 mi)

+34 other locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Alto Neuroscience

Stay on Your Current Meds

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing ALTO-100, a new treatment for depression, to see if it works better than other treatments. It will be used alone or with other antidepressants to find out if it helps reduce symptoms of depression.

Research Team

Adam Savitz, MD, PhD

Principal Investigator

Alto Neuroscience

Eligibility Criteria

This trial is for adults with moderate to severe major depressive disorder (MDD). Participants can be on a stable dose of certain antidepressants or not on medication. They must not be pregnant, breastfeeding, have unstable medical conditions, substance use disorders, other mental health diagnoses like bipolar or psychotic disorders, dementia, or allergies to ALTO-100.

Inclusion Criteria

I am not on antidepressants or have been on one type for at least 6 weeks without changes.

Willing to comply with all study assessments and procedures

Must not be pregnant or breastfeeding at time of enrollment or throughout study

See 1 more

Exclusion Criteria

I have a health condition that is not stable.

Diagnosed bipolar disorder, psychotic disorder, or dementia

Current moderate or severe substance use disorder

See 2 more

Treatment Details

Interventions

ALTO-100 (Other)
Placebo (Other)

Trial OverviewThe study is testing the effectiveness of ALTO-100 compared to a placebo in treating MDD. It will look at how well it works alone or alongside an existing antidepressant. The goal is to see if patient characteristics influence the outcome.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ALTO-100Experimental Treatment1 Intervention

Participants will receive ALTO-100 tablet twice daily, from Day 1 to Day 42 in double blind (DB) treatment period. Eligible participants who will enter the open label (OL) treatment period will receive ALTO-100 tablet twice daily from OL baseline until the end of OL period/early termination visit (Up to 7 weeks).

Group II: Placebo DBPlacebo Group1 Intervention

Participants will receive matching placebo tablet twice daily, from Day 1 to Day 42 in double blind (DB) treatment period.