ALTO-207 in Adults With Treatment-resistant Depression (TRD)
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Treatment-resistant Depression (TRD)
In brief
The purpose of this trial is to measure depressive symptoms following treatment with ALTO-207 compared with placebo in participants with TRD.
Key facts
- Study ID
- NCT07553637
- Run by
- Alto Neuroscience
- People needed
- 178
- Starts
- 2026-05-01
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-04-28
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Site 7151 — Annapolis, Maryland, United States (enrolling)
- Site 7143 — Charlotte, North Carolina, United States (enrolling)
- Site 7029 — Cincinnati, Ohio, United States (enrolling)
- Site 7152 — Saint Augustine, Florida, United States (enrolling)
- Site 7148 — Albany, Georgia, United States (enrolling)
- Site 7082 — Oceanside, California, United States (enrolling)
- Site 7154 — Bloomfield Hills, Michigan, United States (enrolling)
- Site 7144 — San Diego, California, United States (enrolling)
- Site 7141 — Savannah, Georgia, United States (enrolling)
- Site 7145 — Houston, Texas, United States (enrolling)
- Site 7161 — Irving, Texas, United States (enrolling)
- Site 7000 — Phoenix, Arizona, United States (enrolling)
- Site 7155 — Ann Arbor, Michigan, United States
- Site 7170 — Amherst, New York, United States
- Site 7055 — Cedarhurst, New York, United States
- Site 7162 — Lewiston, New York, United States
- Site 7157 — Syracuse, New York, United States
- Site 7158 — Garfield Heights, Ohio, United States
- Site 7172 — East Providence, Rhode Island, United States
- Site 7176 — Dallas, Texas, United States
- Site 7160 — Fort Worth, Texas, United States
- Site 7150 — Galveston, Texas, United States
- Site 7175 — Houston, Texas, United States
- Site 7177 — Fairfax, Virginia, United States
- Site 7128 — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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