NCT05712187CompletedPhase 2
Phase 2b Study of ALTO-100 in MDD
A Randomized, Double-Blind, Placebo-Controlled Study of ALTO-100 With an Open-Label Extension in Adults With Major Depressive Disorder
Source: ClinicalTrials.gov · Last updated 8 Sept 2025
Brief summary (registry, in English)
The purpose of this study is to determine efficacy differences between ALTO-100 and placebo, used either as monotherapy or adjunctively to an antidepressant, related to patient characteristics.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 301 (actual)
- First submitted
- 24 Dec 2022
- Start date
- 10 Jan 2023
- Primary completion date
- 5 Sept 2024
- Lead sponsor
- Alto Neuroscience
- Diseases
- Depression
- NCT number
- NCT05712187
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 301
- From 10 Jan 2023 to the primary completion date, 5 Sept 2024
- 34 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device
Other illness
- Evidence of unstable medical condition
- Diagnosed bipolar disorder, psychotic disorder, or dementia
- Current moderate or severe substance use disorder
- Has a history of hypersensitivity or allergic reaction to ALTO-100 or any of its components/excipients
Who the study is looking for
- Have a diagnosis of moderate to severe major depressive disorder (MDD)
- At baseline, either not taking an antidepressant medication, or currently taking a single SSRI, SNRI, mirtazapine, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks
- Willing to comply with all study assessments and procedures
- Must not be pregnant or breastfeeding at time of enrollment or throughout study
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (34)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.