Actively Recruiting
A Randomized, Double-blind, Placebo-controlled Trial of ALTO-207 in Adults With Treatment-resistant Depression
Led by Alto Neuroscience · Updated on 2026-04-28
178
Participants Needed
48
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ALTO-207 compared to a placebo in adults with treatment-resistant depression (TRD) to measure changes in depressive symptoms. This phase 2 trial aims to better understand the effects of ALTO-207 on depression severity in participants who have not responded well to previous antidepressant treatments. Participants will be randomly assigned to receive either ALTO-207 twice daily or a matching placebo. The study is double-blind and placebo-controlled, ensuring that neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts up to 8 weeks, during which changes in depressive symptoms will be closely monitored. During the study, participants will undergo assessments including the Montgomery-Åsberg Depression Rating Scale (MADRS) to track changes in depression severity from the start through 8 weeks. Additional evaluations include response rates and clinical global impressions of severity over time. Safety and symptom monitoring will occur throughout, and participation may last up to 8 weeks based on treatment and follow-up visits.
CONDITIONS
Brief Title
ALTO-207 in Adults With Treatment-resistant Depression (TRD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants, ages 18 to 75 years, inclusive, at the time of signing the informed consent form
- Prior diagnosis of major depressive disorder (MDD) without psychotic symptoms in the current episode
- Confirmed current moderate to severe MDD
- Failure to respond (less than 50% improvement) to at least 2 to 5 antidepressant treatments including current treatment
- Currently taking a stable dose of at least 1 but no more than 2 oral antidepressants at baseline
You will not qualify if you...
- Evidence of unstable medical condition
- Concurrent use of any prohibited medications or substance use disorder
- Diagnosed bipolar disorder or a psychotic disorder or symptoms
- Significant current PTSD symptoms or history of PTSD
- Clinically significant current impulse control difficulties
- History of hypersensitivity or allergic reaction to ALTO-207 or any components/excipients
- Concurrent or recent participation 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 8 weeks
Participants receive either ALTO-207 or a matching placebo to evaluate the effect on treatment-resistant depression.
Weekly visits for up to 8 weeks
Trial Site Locations
Total: 48 locations
1
Site 7074
Birmingham, Alabama, United States, 35294
Not Yet Recruiting
2
Site 7173
Dothan, Alabama, United States, 36345
Not Yet Recruiting
3
Site 7000
Phoenix, Arizona, United States, 85012
Actively Recruiting
4
Site 7153
Chino, California, United States, 91710
Not Yet Recruiting
5
Site 7156
Oakland, California, United States, 94610
Not Yet Recruiting
6
Site 7082
Oceanside, California, United States, 92056
Actively Recruiting
7
Site 7159
Palo Alto, California, United States, 94304
Not Yet Recruiting
8
Site 7016
Sacramento, California, United States, 95655
Not Yet Recruiting
9
Site 7144
San Diego, California, United States, 92123
Actively Recruiting
10
Site 7171
Valley Village, California, United States, 91607
Not Yet Recruiting
11
Site 7152
Saint Augustine, Florida, United States, 32086
Actively Recruiting
12
Site 7148
Albany, Georgia, United States, 31707
Actively Recruiting
13
Site 7146
Atlanta, Georgia, United States, 30060
Not Yet Recruiting
14
Site 7064
Peachtree Corners, Georgia, United States, 30078
Not Yet Recruiting
15
Site 7141
Savannah, Georgia, United States, 31406
Actively Recruiting
16
Site 7169
Indianapolis, Indiana, United States, 46202
Not Yet Recruiting
17
Site 7151
Annapolis, Maryland, United States, 21401
Actively Recruiting
18
Site 7054
Pikesville, Maryland, United States, 21208
Not Yet Recruiting
19
Site 7166
Worcester, Massachusetts, United States, 01606
Not Yet Recruiting
20
Site 7155
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
21
Site 7154
Bloomfield Hills, Michigan, United States, 48302
Actively Recruiting
22
Site 7170
Amherst, New York, United States, 14226
Not Yet Recruiting
23
Site 7055
Cedarhurst, New York, United States, 11516
Not Yet Recruiting
24
Site 7162
Lewiston, New York, United States, 14214
Not Yet Recruiting
25
Site 7157
Syracuse, New York, United States, 13210
Not Yet Recruiting
26
Site 7143
Charlotte, North Carolina, United States, 28287
Actively Recruiting
27
Site 7029
Cincinnati, Ohio, United States, 45215
Actively Recruiting
28
Site 7158
Garfield Heights, Ohio, United States, 44125
Not Yet Recruiting
29
Site 7172
East Providence, Rhode Island, United States, 02914
Not Yet Recruiting
30
Site 7176
Dallas, Texas, United States, 75243
Not Yet Recruiting
31
Site 7160
Fort Worth, Texas, United States, 76104
Not Yet Recruiting
32
Site 7150
Galveston, Texas, United States, 77555
Not Yet Recruiting
33
Site 7175
Houston, Texas, United States, 77007
Not Yet Recruiting
34
Site 7145
Houston, Texas, United States, 77030
Actively Recruiting
35
Site 7161
Irving, Texas, United States, 75062
Actively Recruiting
36
Site 7177
Fairfax, Virginia, United States, 22030
Not Yet Recruiting
37
Site 7128
Seattle, Washington, United States, 98004
Not Yet Recruiting
38
Site 7163
South Charleston, West Virginia, United States, 25303
Not Yet Recruiting
39
Site 7419
Antrim, United Kingdom
Not Yet Recruiting
40
Site 7411
Birmingham, United Kingdom
Not Yet Recruiting
41
Site 7414
Bristol, United Kingdom
Not Yet Recruiting
42
Site 7412
Cardiff, United Kingdom
Not Yet Recruiting
43
Site 7418
Exeter, United Kingdom
Not Yet Recruiting
44
Site 7415
London, United Kingdom
Not Yet Recruiting
45
Site 7413
Nottingham, United Kingdom
Not Yet Recruiting
46
Site 7410
Oxford, United Kingdom
Not Yet Recruiting
47
Site 7402
Prescot, United Kingdom
Not Yet Recruiting
48
Site 7416
Sheffield, United Kingdom
Not Yet Recruiting
Research Team
A
Alto Neuroscience
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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