ALTO-100-211
Research type
Research Study
Full 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
IRAS ID
1012755
Contact name
Adam Savitz
Contact email
Sponsor organisation
Alto Neuroscience, Inc.
Clinicaltrials.gov Identifier
Research summary
The purpose of this research study is to compare the effects of ALTO-100, the study’s investigational drug, versus placebo (an inactive substance) in treating symptoms of depression in participants who have bipolar disorder with depression (BD-D) and who are also taking mood stabilizers and/or an atypical antipsychotic. In addition, this research is being done to understand the brain activity patterns, thinking (cognition), and behavior that can be seen in a participant with BD-D prior to, and while taking ALTO-100.
This research study will take approximately 12 to 20 weeks of the patients' time. During this time, participants will continue to take their bipolar medications daily as usual without changing the dose of their medication.
The study consists of four periods. The first period is a screening period of up to 6 weeks (42 days) to determine if patients qualify for the study. Upon qualification for the study, participants enter a “double-blind” period (the second period) where they will take the study drug in tablet form twice per day for 6 weeks. It will be either tablets of ALTO-100 or placebo. Double-blind means that neither the patient nor the study doctor will know if the individual participant is taking ALTO-100 or placebo. Randomized means that participants will be selected to take a ALTO-100 or placebo randomly (like the flip of a coin). By design, the number of participants will be equal in each group.
During the study, participants will be asked to complete questionnaires, talk with study staff about their past and present medical and psychiatric history, give saliva, urine, and blood samples, as well as have electroencephalography (EEG) and electrocardiography (ECG) done at various points in time.
The clinical trial is funded by Alto Neuroscience, Inc., and will recruit participants in the US and in the UK.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
25/NE/0157
Date of REC Opinion
20 Oct 2025
REC opinion
Further Information Favourable Opinion