Clinical Research Directory
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ALTO-100 in Bipolar Disorder With Depression (BD-D)
Sponsor: Alto Neuroscience
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2024-10-02
Completion Date
2027-10
Last Updated
2026-10-13
Healthy Volunteers
No
Interventions
ALTO-100
ALTO-100 40 mg tablet BID
Placebo
Placebo tablet BID
Locations (68)
Site 6074
Birmingham, Alabama, United 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 6133
Little Rock, Arkansas, United States
Site 6153
Chino, California, 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 6111
Sacramento, California, United States
Site 6120
San Jose, California, United States
Site 6112
Colorado Springs, Colorado, United States
Site 6174
Jacksonville, Florida, United States
Site 6067
Lauderhill, Florida, United States
Site 6123
Pinellas Park, Florida, United States
Site 6015
Tampa, Florida, United States
Site 6193
Atlanta, Georgia, United States
Site 6068
Atlanta, Georgia, United States
Site 6064
Peachtree Corners, Georgia, United States
Site 6113
Chicago, Illinois, United States
Site 6132
Carmel, Indiana, United States
Site 6101
West Lafayette, Indiana, United States
Site 6151
Baltimore, Maryland, United States
Site 6076
Bel Air, Maryland, United States
Site 6062
Gaithersburg, Maryland, United States
Site 6182
Towson, Maryland, United States
Site 6188
Worcester, Massachusetts, United States
Site 6184
Ann Arbor, Michigan, United States
Site 6155
Ann Arbor, Michigan, United States
Site 6178
Grand Rapids, Michigan, United States
Site 6122
Flowood, Mississippi, 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
Site 6170
Amherst, New York, United States
Site 6137
New York, New York, United States
Site 6127
Cary, North Carolina, United States
Site 6187
Rose Hill, North Carolina, United States
Site 6029
Cincinnati, Ohio, United States
6065
North Canton, Ohio, United States
Site 6075
Westlake, Ohio, United States
Site 6116
Austin, Texas, United States
Site 6105
Beaumont, Texas, United States
Site 6176
Dallas, Texas, United States
Site 6107
Dallas, Texas, United States
Site 6175
Houston, Texas, United States
Site 6072
Houston, Texas, United States
Site 6053
Plano, Texas, United States
Site 6121
Draper, Utah, United States
Site 6177
Fairfax, Virginia, United States
Site 6128
Bellevue, Washington, United States
Site 6409
Derby, United Kingdom
Site 6403
Edinburgh, United Kingdom
Site 6401
Glasgow, United Kingdom
Site 6402
Liverpool, United Kingdom
Site 6408
London, United Kingdom
Site 6407
London, United Kingdom
Site 6400
Newcastle upon Tyne, United Kingdom
Site 6404
Oxford, United Kingdom
Site 6406
Southampton, United Kingdom
Site 6405
York, United Kingdom