Actively Recruiting
ALTO-100 in Bipolar Disorder With Depression (BD-D)
Led by Alto Neuroscience · Updated on 2025-07-16
200
Participants Needed
27
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
ALTO-100 in Bipolar Disorder With Depression (BD-D)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a diagnosis of Bipolar Disorder I or Bipolar Disorder II with a current major depressive episode
- Currently taking a mood stabilizer (lithium, lamotrigine, valproic acid, or their combinations) and/or an approved atypical antipsychotic medication
- On stable doses of these medications for at least 6 weeks with no changes in the past 2 weeks
- Willing to follow all study assessments and procedures
- Not pregnant or breastfeeding at the time of enrollment and throughout the study
You will not qualify if you...
- Having an unstable medical condition
- Using any prohibited medications or having a substance use disorder
- Diagnosed with a psychotic disorder other than mania or depression
- Currently experiencing a moderate or severe substance use disorder
- History of allergic reaction or hypersensitivity to ALTO-100 or its ingredients
- Currently or recently participating in another clinical trial for mental illness involving an investigational product or device
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
Site 6036
Chandler, Arizona, United States, 85224
Withdrawn
2
Site 6000
Phoenix, Arizona, United States, 85012
Actively Recruiting
3
Site 6087
Yuma, Arizona, United States, 85364
Actively Recruiting
4
6039
Fayetteville, Arkansas, United States, 72703
Actively Recruiting
5
6070
Little Rock, Arkansas, United States, 72204
Actively Recruiting
6
Site 6081
Imperial, California, United States, 92251
Actively Recruiting
7
6069
Los Angeles, California, United States, 90025
Actively Recruiting
8
Site 6016
Mather, California, United States, 95655
Not Yet Recruiting
9
Site 6082
Oceanside, California, United States, 92056
Actively Recruiting
10
Site 6102
Riverside, California, United States, 92506
Actively Recruiting
11
Site 6112
Colorado Springs, Colorado, United States, 80910
Not Yet Recruiting
12
Site 6067
Lauderhill, Florida, United States, 33319
Withdrawn
13
Site 6068
Atlanta, Georgia, United States, 30328
Actively Recruiting
14
Site 6064
Peachtree Corners, Georgia, United States, 30071
Actively Recruiting
15
Site 6151
Baltimore, Maryland, United States, 21229
Withdrawn
16
Site 6076
Bel Air, Maryland, United States, 21015
Actively Recruiting
17
Site 6062
Gaithersburg, Maryland, United States, 20877
Actively Recruiting
18
Site 6142
Lincoln, Nebraska, United States, 68526
Actively Recruiting
19
Site 6144
Las Vegas, Nevada, United States, 89102
Actively Recruiting
20
Site 6104
Las Vegas, Nevada, United States, 89119
Actively Recruiting
21
Site 6066
Toms River, New Jersey, United States, 08755
Actively Recruiting
22
Site 6014
Albuquerque, New Mexico, United States, 87108
Not Yet Recruiting
23
Site 6078
Albuquerque, New Mexico, United States, 87110
Actively Recruiting
24
6065
North Canton, Ohio, United States, 44720
Actively Recruiting
25
Site 6075
Westlake, Ohio, United States, 44145
Actively Recruiting
26
Site 6072
Houston, Texas, United States, 77081
Actively Recruiting
27
Site 6121
Draper, Utah, United States, 84020
Not Yet Recruiting
Research Team
A
Alto Neuroscience
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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