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

NCT06656416 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-07-16

No results posted yet for this study

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

Interventions

DRUG

ALTO-100

ALTO-100 40 mg tablet BID

DRUG

Placebo

Placebo tablet BID

Sponsors & Collaborators

  • Alto Neuroscience

    lead INDUSTRY

Principal Investigators

  • Adam Savitz, MD, PhD · Alto Neuroscience

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-02
Primary Completion
2026-08-31
Completion
2026-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06656416 on ClinicalTrials.gov