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
Status: Recruiting
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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
Locations
United States
Arkansas
6039
RECRUITING
Fayetteville
6070
RECRUITING
Little Rock
Arizona
Site 6036
WITHDRAWN
Chandler
Site 6000
RECRUITING
Phoenix
Site 6087
RECRUITING
Yuma
California
Site 6081
RECRUITING
Imperial
6069
RECRUITING
Los Angeles
Site 6016
NOT_YET_RECRUITING
Mather
Site 6082
RECRUITING
Oceanside
Site 6102
RECRUITING
Riverside
Colorado
Site 6112
NOT_YET_RECRUITING
Colorado Springs
Florida
Site 6067
WITHDRAWN
Lauderhill
Georgia
Site 6068
RECRUITING
Atlanta
Site 6064
RECRUITING
Peachtree Corners
Maryland
Site 6151
WITHDRAWN
Baltimore
Site 6076
RECRUITING
Bel Air
Site 6062
RECRUITING
Gaithersburg
Nebraska
Site 6142
RECRUITING
Lincoln
New Jersey
Site 6066
RECRUITING
Toms River
New Mexico
Site 6014
NOT_YET_RECRUITING
Albuquerque
Site 6078
RECRUITING
Albuquerque
Nevada
Site 6104
RECRUITING
Las Vegas
Site 6144
RECRUITING
Las Vegas
Ohio
6065
RECRUITING
North Canton
Site 6075
RECRUITING
Westlake
Texas
Site 6072
RECRUITING
Houston
Utah
Site 6121
NOT_YET_RECRUITING
Draper
Contact Information
Primary
Alto Neuroscience
clinical@altoneuroscience.com
650-200-0412
Time Frame
Start Date:2024-10-02
Estimated Completion Date:2026-10
Participants
Target number of participants:200
Treatments
Experimental: ALTO-100
Participants will receive ALTO-100 40 mg tablet twice daily, from Day 1 to Week 6 in the double blind (DB) treatment period. Eligible participants who enter the open label (OL) treatment period will receive ALTO-100 40 mg tablet twice daily from OL baseline until the end of OL period/early termination visit (Up to 7 weeks).
Placebo_comparator: Placebo DB
Participants will receive matching placebo tablet twice daily, from Day 1 to Week 6 in the double blind (DB) treatment period.