Clinical Trials

ALTO-100 in bipolar disorder with depression (BD-D)

Study status: Recruiting

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.

Participation criteria
Conditions & interventions
More information
  • Sex: All
  • Minimum age: 18 Years
  • Maximum age: 70 Years

Researchers look for people who fit a certain description, called eligibility criteria. Below are the inclusion and exclusion criteria for study participants:

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

Conditions

Bipolar disorder I or II with a major depressive episode

Intervention/treatment

Intervention/treatment

  • Drug: ALTO-100
  • Drug: Placebo

Sponsor

Alto Neuroscience

Phase

  • Phase 2