Clinical trialNCT06656416RecruitingPhase 2Interventional

ALTO-100 in Bipolar Disorder With Depression (BD-D)

SponsorAlto NeuroscienceEnrollment200Bipolar Disorder I or II With a Major Depressive Episode

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose of this study is to assess antidepressant efficacy differences between ALTO-100 and placebo during the Double-Blind period in patients with bipolar disorder I or II with current major depressive episode, when used adjunctively to a mood stabilizer and/or atypical antipsychotic, related to patient characteristics. Additionally, safety, tolerability, and efficacy will be assessed in a subsequent open label treatment period.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Adam Savitz, MD, PhD
Alto Neuroscience
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

27 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Site 6036
Chandler, Arizona, United States
Withdrawn
Site 6000
Phoenix, Arizona, United States
Recruiting
Site 6087
Yuma, Arizona, United States
Recruiting
6039
Fayetteville, Arkansas, United States
Recruiting
6070
Little Rock, Arkansas, United States
Recruiting
Site 6081
Imperial, California, United States
Recruiting
6069
Los Angeles, California, United States
Recruiting
Site 6016
Mather, California, United States
Not, yet, recruiting
Site 6082
Oceanside, California, United States
Recruiting
Site 6102
Riverside, California, United States
Recruiting
Site 6112
Colorado Springs, Colorado, United States
Not, yet, recruiting
Site 6067
Lauderhill, Florida, United States
Withdrawn
Site 6068
Atlanta, Georgia, United States
Recruiting
Site 6064
Peachtree Corners, Georgia, United States
Recruiting
Site 6151
Baltimore, Maryland, United States
Withdrawn
Site 6076
Bel Air, Maryland, United States
Recruiting
Site 6062
Gaithersburg, Maryland, United States
Recruiting
Site 6142
Lincoln, Nebraska, United States
Recruiting
Site 6104
Las Vegas, Nevada, United States
Recruiting
Site 6144
Las Vegas, Nevada, United States
Recruiting
Site 6066
Toms River, New Jersey, United States
Recruiting
Site 6014
Albuquerque, New Mexico, United States
Not, yet, recruiting
Site 6078
Albuquerque, New Mexico, United States
Recruiting
6065
North Canton, Ohio, United States
Recruiting
Site 6075
Westlake, Ohio, United States
Recruiting
Site 6072
Houston, Texas, United States
Recruiting
Site 6121
Draper, Utah, United States
Not, yet, recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

ALTO-100Placebo

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 2 Oct 2024
Primary completion: 31 Aug 2026
Completion: 31 Oct 2026
Last update posted: 16 Jul 2025
Registered enrollment: 200
Registry id: NCT06656416

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.