Tests ALTO-100 for depression in adults with bipolar disorder
Compares ALTO-100 with a placebo in adults with bipolar depression.
Plain-language title generated from the registry record
Registry title: ALTO-100 in Bipolar Disorder With Depression (BD-D)
Key facts
- Where
- Albuquerque, Amherst, Ann Arbor, Atlanta, Austin, Baltimore, Beaumont, Bel Air, Bellevue, Birmingham, Carmel, Cary, Chandler, Chicago, Chino, Cincinnati, Colorado Springs, Dallas, Draper, Fairfax, Fayetteville, Flowood, Gaithersburg, Grand Rapids, Houston, Imperial, Jacksonville, Las Vegas, Lauderhill, Lincoln, Little Rock, Los Angeles, Mather, New York, North Canton, Oceanside, Peachtree Corners, Phoenix, Pinellas Park, Plano, Riverside, Rose Hill, Sacramento, San Jose, Tampa, Toms River, Towson, West Lafayette, Westlake, Worcester, and Yuma, United StatesSee the 58 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06656416, who can take part
Where in United States
- AlbuquerqueAlbuquerque, United StatesTaking people
- AlbuquerqueAlbuquerque, United StatesNo longer taking part
- AmherstAmherst, United StatesTaking people
- Ann ArborAnn Arbor, United StatesTaking people
- Ann ArborAnn Arbor, United StatesTaking people
- AtlantaAtlanta, United StatesNot yet recruiting
- AtlantaAtlanta, United StatesNo longer taking part
- AustinAustin, United StatesTaking people
- BaltimoreBaltimore, United StatesNo longer taking part
- BeaumontBeaumont, United StatesTaking people
- Bel AirBel Air, United StatesTaking people
- BellevueBellevue, United StatesNo longer taking part
- BirminghamBirmingham, United StatesNo longer taking part
- CarmelCarmel, United StatesTaking people
- CaryCary, United StatesTaking people
- ChandlerChandler, United StatesNo longer taking part
- ChicagoChicago, United StatesTaking people
- ChinoChino, United StatesTaking people
- CincinnatiCincinnati, United StatesTaking people
- Colorado SpringsColorado Springs, United StatesTaking people
- DallasDallas, United StatesTaking people
- DallasDallas, United StatesTaking people
- DraperDraper, United StatesNo longer taking part
- FairfaxFairfax, United StatesTaking people
- 6039Fayetteville, United StatesNo longer taking part
- FlowoodFlowood, United StatesTaking people
- GaithersburgGaithersburg, United StatesTaking people
- Grand RapidsGrand Rapids, United StatesTaking people
- HoustonHouston, United StatesTaking people
- HoustonHouston, United StatesNo longer taking part
- ImperialImperial, United StatesNo longer taking part
- JacksonvilleJacksonville, United StatesTaking people
- Las VegasLas Vegas, United StatesTaking people
- Las VegasLas Vegas, United StatesTaking people
- LauderhillLauderhill, United StatesNo longer taking part
- LincolnLincoln, United StatesNo longer taking part
- Little RockLittle Rock, United StatesTaking people
- 6070Little Rock, United StatesNo longer taking part
- 6069Los Angeles, United StatesTaking people
- MatherMather, United StatesTaking people
- New YorkNew York, United StatesTaking people
- 6065North Canton, United StatesNo longer taking part
- OceansideOceanside, United StatesNo longer taking part
- Peachtree CornersPeachtree Corners, United StatesTaking people
- PhoenixPhoenix, United StatesTaking people
- Pinellas ParkPinellas Park, United StatesTaking people
- PlanoPlano, United StatesTaking people
- RiversideRiverside, United StatesNo longer taking part
- Rose HillRose Hill, United StatesTaking people
- SacramentoSacramento, United StatesTaking people
- San JoseSan Jose, United StatesTaking people
- TampaTampa, United StatesTaking people
- Toms RiverToms River, United StatesTaking people
- TowsonTowson, United StatesTaking people
- West LafayetteWest Lafayette, United StatesNo longer taking part
- WestlakeWestlake, United StatesTaking people
- WorcesterWorcester, United StatesTaking people
- YumaYuma, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Alto Neuroscience
- Trial code
- NCT06656416
- Record updated
- 13 October 2026
- Original description
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.Read full original descriptionShow less
A Randomized, Double-Blind, Placebo-Controlled Study Followed by Open-Label Treatment of ALTO-100 in Adults With Bipolar Disorder Currently Experiencing a Major Depressive Episode
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.
Inclusion: Have a diagnosis of BD-I or BD-II as well as BD-D; At baseline, taking a mood stabilizer, lithium (LI) or lamotrigine (LMG) or valproic acid (VPA, any form) or combination of Li + LMG or Li + VPA and/or taking an approved atypical antipsychotic medication (olanzapine, quetiapine, lurasidone, risperidone, ziprasidone, cariprazine, aripiprazole, lumateperone, asenapine, Iloperidone and Milsaperidone) 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.
Exclusion: Concurrent use of any prohibited medications or substance use disorder; Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device; Evidence of unstable medical condition; Diagnosed psychotic disorder (other than mania or depression); Current moderate or severe substance use disorder; Has a history of hypersensitivity or allergic reaction to ALTO-100 or any of its components/excipients.