ALTO-100 in Bipolar Disorder With Depression (BD-D)
Recruiting · NCT06656416 · Interventional (participants receive a specific treatment) · Lead sponsor: Alto Neuroscience
View the official record on ClinicalTrials.gov →Interventions studied
ALTO-100Placebo
What this trial is about
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.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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, and asenapine) 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
Where it is running
27 locations listed across 14 US states.
- Site 6036 - Chandler, Arizona, United States
- Site 6000 - Phoenix, Arizona, United States
- Site 6087 - Yuma, Arizona, United States
- 6039 - Fayetteville, Arkansas, United States
- 6070 - Little Rock, Arkansas, United States
- Site 6081 - Imperial, California, United States
- 6069 - Los Angeles, California, United States
- Site 6016 - Mather, California, United States
- Site 6082 - Oceanside, California, United States
- Site 6102 - Riverside, California, United States
- Site 6112 - Colorado Springs, Colorado, United States
- Site 6067 - Lauderhill, Florida, United States
- Site 6068 - Atlanta, Georgia, United States
- Site 6064 - Peachtree Corners, Georgia, United States
- Site 6151 - Baltimore, Maryland, United States
- Site 6076 - Bel Air, Maryland, United States
- Site 6062 - Gaithersburg, Maryland, United States
- Site 6142 - Lincoln, Nebraska, United States
- Site 6144 - Las Vegas, Nevada, United States
- Site 6104 - Las Vegas, Nevada, United States
- Site 6066 - Toms River, New Jersey, United States
- Site 6014 - Albuquerque, New Mexico, United States
- Site 6078 - Albuquerque, New Mexico, United States
- 6065 - North Canton, Ohio, United States
- Site 6075 - Westlake, Ohio, United States
- Site 6072 - Houston, Texas, United States
- Site 6121 - Draper, Utah, United States