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ALTO-100 for Bipolar Disorder with Depression

This study is testing a medication called ALTO-100 to see if it can help improve symptoms of depression in people with Bipolar Disorder I or II. Participants will receive either ALTO-100 or a placebo (an inactive pill) in addition to their current mood stabilizer or atypical antipsychotic medication. Researchers will measure changes in depression symptoms using a scale called the Montgomery-Åsberg Depression Rating Scale (MADRS) over six weeks to see if ALTO-100 is effective. The study also aims to understand the safety and tolerability of ALTO-100. You may be able to join if you are between 18 and 70 years old, have Bipolar Disorder I or II with a current major depressive episode, and are already taking certain mood stabilizers or antipsychotic medications. The study plans to enroll about 200 people, but its current recruitment status is unclear.

Study design
This is an interventional study comparing ALTO-100 to a placebo. It plans to enroll 200 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Efficacy will be assessed from Day 1 to Week 6. Safety, tolerability, and efficacy will also be assessed in a subsequent open-label treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06656416

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

Recruiting
PHASE2Ages 18–70InterventionalTreatment
Alto Neuroscience
~200 participants
Updated 2025-07-16 on ClinicalTrials.gov
What's tested:ALTO-100Placebo

At a glance

Recruiting sites
20 of 27 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over Change assessed from Day 1 to Week 6

Conditions

Bipolar Disorder I or II With a Major Depressive Episode

Explore related trials

Bipolar DisorderUnipolar Depression

Where it's being run

27 sites across 14 states
California5
Arizona3
Maryland3
Arkansas2
Georgia2
Nevada2
New Mexico2
Ohio2

Study leadership

  • Adam Savitz, MD, PhD · STUDY_DIRECTOR · Alto Neuroscience

Who to contact

Alto Neuroscience
[email protected]
650-200-0412
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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, 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

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

What this trial measures

  • 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 scoreChange assessed from Day 1 to Week 6

    MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.