Evaluating ALTO-203 for treating major depressive disorder

Double-Blind, Single and Multiple Dose Study to Determine Pharmacodynamic Markers, Pharmacokinetic Parameters, and Safety of ALTO-203 in Patients With Major Depressive Disorder

This study is testing a new medication called ALTO-203 to see if it can help people with major depressive disorder who struggle to feel pleasure.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 25 Years to 64 Years
• Sex: All
• Sponsor: Alto Neuroscience (Industry-sponsored)
• Locations: 15 sites (Tucson, Arizona and 14 other locations)
• Trial ID: NCT06391593 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the pharmacodynamic effects, safety, and tolerability of ALTO-203 in patients diagnosed with major depressive disorder (MDD) and experiencing anhedonia. The study employs a randomized, placebo-controlled, single-dose crossover design followed by a multi-dose parallel-group treatment period lasting 28 days. Participants will receive either ALTO-203 at doses of 25 μg or 75 μg, or a placebo, while completing subjective response questionnaires and cognitive tasks to evaluate the drug's effects. Safety assessments will be conducted throughout both treatment periods.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with moderate major depressive disorder who exhibit symptoms of anhedonia and are not currently taking antidepressants.

Not a fit: Patients with unstable medical conditions, bipolar disorder, psychotic disorders, or those currently using prohibited medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients suffering from major depressive disorder and anhedonia.

How similar studies have performed: Other studies have shown promise in evaluating novel treatments for major depressive disorder, but the specific approach of ALTO-203 is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Have a diagnosis of moderate major depressive disorder (MDD)
* Presence of anhedonia symptoms
* Not taking antidepressant at Screening Visit 2
* Willing to comply with all study assessments and procedures

Exclusion Criteria:

* Evidence of unstable medical condition
* Diagnosed bipolar disorder, psychotic disorder, or dementia
* Concurrent use of prohibited medications
* Current moderate or severe substance use disorder
* Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device

Where this trial is running

Tucson, Arizona and 14 other locations

• Site 4058 — Tucson, Arizona, United States (Recruiting)
• Site 4082 — Oceanside, California, United States (Recruiting)
• Site 4023 — Torrance, California, United States (Recruiting)
• Site 4059 — Clermont, Florida, United States (Recruiting)
• Site 4005 — Orlando, Florida, United States (Recruiting)
• Site 4031 — Atlanta, Georgia, United States (Recruiting)
• Site 4054 — Pikesville, Maryland, United States (Recruiting)
• Site 4036 — Las Vegas, Nevada, United States (Recruiting)
• Site 4022 — Berlin, New Jersey, United States (Recruiting)
• Site 4134 — Princeton, New Jersey, United States (Recruiting)
• Site 4075 — Westlake, Ohio, United States (Not_yet_recruiting)
• Site 4040 — Austin, Texas, United States (Recruiting)
• Site 4072 — Houston, Texas, United States (Recruiting)
• Site 4007 — Clinton, Utah, United States (Recruiting)
• Site 4033 — Bellevue, Washington, United States (Recruiting)

Study contacts

• Study coordinator: Alto Neuroscience

Conditions Major Depressive Disorder; Anhedonia