ALTO-100 in Bipolar Disorder With Depression (BD-D)
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.
Have a diagnosis of BD-I or BD-II as well as BD-D [+3]
Evidence of unstable medical condition [+5]