ALTO-100 for Bipolar Depression

Recruiting at 3 trial locations

Overseen By Alto Neuroscience

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Verified Trial

Recruiting

Sponsor: Alto Neuroscience

Must be taking: Mood stabilizers

Must not be taking: Prohibited medications

Disqualifiers: Unstable medical condition, Psychotic disorder, Substance use disorder, others

Stay on Your Current Meds

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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, related to patient characteristics. Additionally, safety, tolerability, and efficacy will be assessed in a subsequent open label treatment period.

Will I have to stop taking my current medications?

The trial requires participants to continue taking a mood stabilizer like lithium, lamotrigine, or valproic acid, without changing the dose for at least 6 weeks before starting. If you're on other medications, the protocol doesn't specify, so it's best to discuss with the trial team.

Research Team

Mallory Loflin, PhD

Principal Investigator

Alto Neuroscience

Eligibility Criteria

This trial is for individuals with bipolar disorder (either type I or II) who are currently experiencing a major depressive episode. Participants must be on a mood stabilizer to join the study. Specific details about what excludes someone from participating aren't provided here.

Inclusion Criteria

Are you taking a stable dose of any of the medications listed below for Bipolar? Lamotrigine, valproic acid, lamictal, olanzapine, quetiapine, lurasidone, risperidone, ziprasidone, cariprazine, aripiprazole, lumateperone, or asenapine

Are you currently taking mood stabilizers, lithium, lamotrigine, valproic acid, or an atypical antipsychotic?

Exclusion Criteria

Have you been diagnosed with Schizophrenia?

Do you use any substances and/or street drugs including marijuana and alcohol?

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-Blind Treatment

Participants receive either ALTO-100 or placebo adjunctively to a mood stabilizer for 6 weeks

6 weeks

4 visits (in-person)

Open-Label Treatment

Eligible participants receive ALTO-100 for up to 7 weeks

7 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ALTO-100 (Other)

Trial Overview The study is testing the effectiveness of ALTO-100 compared to a placebo in reducing symptoms of depression in bipolar disorder when taken alongside standard mood stabilizers. It includes an initial double-blind phase followed by an open label period where all participants know they're receiving ALTO-100.

Participant Groups

Group I: ALTO-100 Experimental Treatment 1 Intervention

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).

Group II: Placebo DB Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Alto Neuroscience

Lead Sponsor

Trials

11

Recruited

1,300+