NCT07553637 ALTO-207 in Adults With Treatment-resistant Depression (TRD)
| NCT ID | NCT07553637 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Alto Neuroscience |
| Condition | Treatment-resistant Depression (TRD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 178 participants |
| Start Date | 2026-05 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 178 participants in total. It began in 2026-05 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this trial is to measure depressive symptoms following treatment with ALTO-207 compared with placebo in participants with TRD.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07553637 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Treatment-resistant Depression (TRD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07553637 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07553637 currently recruiting?
Yes, NCT07553637 is actively recruiting participants. Contact the research team at clinical@altoneuroscience.com for enrollment information.
Where is the NCT07553637 trial being conducted?
This trial is being conducted at Birmingham, United States, Dothan, United States, Phoenix, United States, Chino, United States and 11 additional locations.
Who is sponsoring the NCT07553637 clinical trial?
NCT07553637 is sponsored by Alto Neuroscience. The trial plans to enroll 178 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.