200 Participants Needed

ALTO-100 for Bipolar Depression

Recruiting at 3 trial locations
AN
Overseen ByAlto Neuroscience
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Alto Neuroscience
Must be taking: Mood stabilizers
Stay on Your Current MedsYou can continue your current medications while participating
Prior Safety DataThis treatment has passed at least one previous human trial
2 Power Preferred Clinics2 of this trial's clinics are considered top 20 on Power

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

ML

Mallory Loflin, PhD

Principal Investigator

Alto Neuroscience

Are You a Good Fit for This Trial?

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

Exclusion Criteria

Have you been diagnosed with Schizophrenia?
Do you use any substances and/or street drugs including marijuana and alcohol?

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • ALTO-100
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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ALTO-100Experimental Treatment1 Intervention
Group II: Placebo DBPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alto Neuroscience

Lead Sponsor

Trials
11
Recruited
1,300+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
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