ALTO-207-201
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled Trial of ALTO-207 in Adults With Treatment-resistant Depression
IRAS ID
1013538
Contact name
Tim Peters-Strickland
Contact email
Sponsor organisation
Alto Neuroscience, Inc.
Clinicaltrials.gov Identifier
Research summary
The purpose of this research study is to measure depressive symptoms, safety and tolerability following treatment with ALTO-207 compared with placebo (an inactive substance) in participants with treatment-resistant depression.
This research study will take approximately up to 17 weeks of the patients' time. During this time, participants will continue taking their current trial-allowed antidepressant medication(s) at a stable dose throughout the study.
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 the "double-blind" treatment period where they will take the study drug in tablet form twice per day for up to 70 days. Per randomization, it will be either tablets of ALTO-207 or placebo. Double-blind means that neither the patient nor the study doctor will know if the individual participant is taking ALTO-207 or placebo. Randomized means that participants will be selected to take a ALTO-207 or placebo randomly (like the flip of a coin). By design, the number of participants will be equal in each group. Initially, the dose received will be increased stepwise during up to 2 weeks, followed by a period of stable dose for 6 weeks. At the end of the treatment period the dose will be decreased stepwise during 14 days. After the end of this taper period, a final follow-up visit will occur after another week.
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 2 Research Ethics Committee
REC reference
26/NE/0078
Date of REC Opinion
19 May 2026
REC opinion
Further Information Favourable Opinion