NCT07553637 · Alto Neuroscience
ALTO-207 in Adults With Treatment-resistant Depression (TRD)
What this study is about
The purpose of this trial is to measure depressive symptoms following treatment with ALTO-207 compared with placebo in participants with TRD.
View original scientific description
The purpose of this trial is to measure depressive symptoms following treatment with ALTO-207 compared with placebo in participants with TRD.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male and female participants, ages 18 to 75 years, inclusive, at the time of signing the ICF.
- Prior diagnosis of MDD without psychotic symptoms (in the current episode) and have confirmatory diagnosis of current MDD (moderate to severe).
- Failure to respond (\<50% improvement) to at least 2-5 antidepressant treatments (including the current treatment)
- Currently taking a stable dose of at least 1 but no more than 2 oral antidepressants at baseline
Exclusion criteria
- 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
- Has a history of hypersensitivity or allergic reaction to ALTO-207 or any of its components/excipients
- Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device
Where
- Birmingham, Alabama
- Dothan, Alabama
- Phoenix, Arizona
- Chino, California
- Oakland, California
- Oceanside, California
- Palo Alto, California
- Sacramento, California
- San Diego, California
- Valley Village, California
- Saint Augustine, Florida
- Albany, Georgia
And 25 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 28, 2026 · Source of record for eligibility and locations