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RecruitingPhase 2

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

A Randomized, Double-Blind, Placebo-Controlled Study Followed by Open-Label Treatment of ALTO-100 in Adults With Bipolar Disorder Currently Experiencing a Major Depressive Episode

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares ALTO-100 with a placebo (a pill with no active medicine) for people with bipolar I or II disorder who are now having major depression. ALTO-100 is added to their current mood medicines, and researchers will look at how patient traits affect results. A later phase will also check its safety, side effects, and how well it works.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have bipolar I or II disorder and currently have major depression.
  • Take a mood stabilizer and/or an antipsychotic medicine allowed by the study. These medicines help manage mood symptoms.
  • Have taken these medicines for at least 6 weeks, with no dose changes in the past 2 weeks.
  • Be willing to complete all study tests and steps.
  • Not be pregnant or breastfeeding when joining or during the study.

Who can't join

  • Have a medical condition that is not stable.
  • Take any medicines that the study does not allow.
  • Have a substance use disorder, meaning problems controlling alcohol or drug use. Current moderate or severe problems are also listed as a reason you cannot join.
  • Have a diagnosed psychotic disorder, which can affect your sense of what is real, other than mania or depression.
  • Have had an allergic reaction to ALTO-100 or any of its ingredients.
  • Are taking part in, or recently took part in, another mental illness trial testing an experimental treatment or device.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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, asenapine, Iloperidone and Milsaperidone) 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 sites (58)

AL

AR

AZ

CA

CO

FL

GA

IL

IN

MA

MD

MI

MS

NC

NE

NJ

NM

NV

NY

OH

TX

UT

VA

WA