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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Alto Neuroscience • ClinicalTrials.gov ID: NCT06656416

Registry updated: 2026-10-13
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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.

Interventions

  • ALTO-100 (Drug)
    ALTO-100 40 mg tablet BID
  • Placebo (Drug)
    Placebo tablet BID

Eligibility criteria

Inclusion Criteria: * 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 Criteria: * Evidence of unstable medical condition * Concurrent use of any prohibited medications or substance use disorder * 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 * Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device

Conditions

Bipolar Disorder I or II With a Major Depressive Episode

Locations

  • Site 6074 — Birmingham, Alabama, United States
  • Site 6036 — Chandler, Arizona, United States
  • Site 6000 — Phoenix, Arizona, United States
  • Site 6087 — Yuma, Arizona, United States
  • 6039 — Fayetteville, Arkansas, United States
  • 6070 — Little Rock, Arkansas, United States
  • Site 6133 — Little Rock, Arkansas, United States
  • Site 6153 — Chino, California, United States
  • Site 6081 — Imperial, California, United States
  • 6069 — Los Angeles, California, United States
  • Site 6016 — Mather, California, United States
  • Site 6082 — Oceanside, California, United States
  • Site 6102 — Riverside, California, United States
  • Site 6111 — Sacramento, California, United States
  • Site 6120 — San Jose, California, United States
  • Site 6112 — Colorado Springs, Colorado, United States
  • Site 6174 — Jacksonville, Florida, United States
  • Site 6067 — Lauderhill, Florida, United States
  • Site 6123 — Pinellas Park, Florida, United States
  • Site 6015 — Tampa, Florida, United States
  • Site 6193 — Atlanta, Georgia, United States
  • Site 6068 — Atlanta, Georgia, United States
  • Site 6064 — Peachtree Corners, Georgia, United States
  • Site 6113 — Chicago, Illinois, United States
  • Site 6132 — Carmel, Indiana, United States
  • Site 6101 — West Lafayette, Indiana, United States
  • Site 6151 — Baltimore, Maryland, United States
  • Site 6076 — Bel Air, Maryland, United States
  • Site 6062 — Gaithersburg, Maryland, United States
  • Site 6182 — Towson, Maryland, United States
  • Site 6188 — Worcester, Massachusetts, United States
  • Site 6184 — Ann Arbor, Michigan, United States
  • Site 6155 — Ann Arbor, Michigan, United States
  • Site 6178 — Grand Rapids, Michigan, United States
  • Site 6122 — Flowood, Mississippi, United States
  • Site 6142 — Lincoln, Nebraska, United States
  • Site 6144 — Las Vegas, Nevada, United States
  • Site 6104 — Las Vegas, Nevada, United States
  • Site 6066 — Toms River, New Jersey, United States
  • Site 6014 — Albuquerque, New Mexico, United States
  • Site 6078 — Albuquerque, New Mexico, United States
  • Site 6170 — Amherst, New York, United States
  • Site 6137 — New York, New York, United States
  • Site 6127 — Cary, North Carolina, United States
  • Site 6187 — Rose Hill, North Carolina, United States
  • Site 6029 — Cincinnati, Ohio, United States
  • 6065 — North Canton, Ohio, United States
  • Site 6075 — Westlake, Ohio, United States
  • Site 6116 — Austin, Texas, United States
  • Site 6105 — Beaumont, Texas, United States
  • Site 6176 — Dallas, Texas, United States
  • Site 6107 — Dallas, Texas, United States
  • Site 6175 — Houston, Texas, United States
  • Site 6072 — Houston, Texas, United States
  • Site 6053 — Plano, Texas, United States
  • Site 6121 — Draper, Utah, United States
  • Site 6177 — Fairfax, Virginia, United States
  • Site 6128 — Bellevue, Washington, United States
  • Site 6409 — Derby, United Kingdom
  • Site 6403 — Edinburgh, United Kingdom
  • Site 6401 — Glasgow, United Kingdom
  • Site 6402 — Liverpool, United Kingdom
  • Site 6408 — London, United Kingdom
  • Site 6407 — London, United Kingdom
  • Site 6400 — Newcastle upon Tyne, United Kingdom
  • Site 6404 — Oxford, United Kingdom
  • Site 6406 — Southampton, United Kingdom
  • Site 6405 — York, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record