Recruiting
Phase 2

ALTO-100

Sponsor:

Alto Neuroscience

Code:

NCT06656416

Conditions

Bipolar Disorder I or II With a Major Depressive Episode

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

ALTO-100

Placebo

Study Details

Brief summary:

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.

Conditions

Bipolar Disorder I or II With a Major Depressive Episode

Study ID

NCT06656416

Start date

Oct 2, 2024

Status verified date

Jul, 2025

Completion date

Oct, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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, and asenapine) 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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ALTO-100

Participants will receive ALTO-100 40 mg tablet twice daily, from Day 1 to Week 6 in the double blind (DB) treatment period. Eligible participants who enter the open label (OL) treatment period will receive ALTO-100 40 mg tablet twice daily from OL baseline until the end of OL period/early termination visit (Up to 7 weeks).

placebo comparator: Placebo DB

Participants will receive matching placebo tablet twice daily, from Day 1 to Week 6 in the double blind (DB) treatment period.

Interventions

ALTO-100

ALTO-100 40 mg tablet BID

Placebo

Placebo tablet BID

Primary outcome measure

  • To assess efficacy of ALTO-100 versus placebo on depression symptoms in bipolar disorder in a pre-defined subgroup of participants as measured by the mean change from Day 1 to Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score [ Time Frame: Change assessed from Day 1 to Week 6 ]

Central Contacts and Locations

Central contacts

Alto Neuroscience

650-200-0412clinical@altoneuroscience.com

Locations

Site 6000

Recruiting

Phoenix, Arizona, United States, 85012

Site 6087

Recruiting

Yuma, Arizona, United States, 85364

6039

Recruiting

Fayetteville, Arkansas, United States, 72703

6070

Recruiting

Little Rock, Arkansas, United States, 72204

Site 6081

Recruiting

Imperial, California, United States, 92251

6069

Recruiting

Los Angeles, California, United States, 90025

Site 6082

Recruiting

Oceanside, California, United States, 92056

Site 6102

Recruiting

Riverside, California, United States, 92506

Site 6068

Recruiting

Atlanta, Georgia, United States, 30328

Site 6064

Recruiting

Peachtree Corners, Georgia, United States, 30071

Site 6076

Recruiting

Bel Air, Maryland, United States, 21015

Site 6062

Recruiting

Gaithersburg, Maryland, United States, 20877

Site 6142

Recruiting

Lincoln, Nebraska, United States, 68526

Site 6144

Recruiting

Las Vegas, Nevada, United States, 89102

Site 6104

Recruiting

Las Vegas, Nevada, United States, 89119

Site 6066

Recruiting

Toms River, New Jersey, United States, 08755

Site 6078

Recruiting

Albuquerque, New Mexico, United States, 87110

6065

Recruiting

North Canton, Ohio, United States, 44720

Site 6075

Recruiting

Westlake, Ohio, United States, 44145

Site 6072

Recruiting

Houston, Texas, United States, 77081

More Information

Sponsor

Alto Neuroscience

Last update posted

Jul 16, 2025

Last verified

Jul, 2025

Keywords

  • Bipolar I
  • Bipolar II
  • Major Depressive Episode

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Alto Neuroscience on 2025-07-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.