PD, PK, and Safety of ALTO-203 in Patients With MDD
Completed · Phase 2 · Has a placebo group
Conditions studied: Major Depressive Disorder, Anhedonia
In brief
The goal of this clinical trial is to determine the pharmacodynamic effects of ALTO-203 in patients with MDD in a randomized, placebo-controlled, single-dose crossover treatment period. Additionally, safety, tolerability, and PK will be assessed in a subsequent randomized placebo-controlled multi-dose parallel-group treatment period of 28 days. Participants will complete subjective response questionnaires and perform cognitive tasks during the single-dose period, in which participants will receive ALTO-203 25 μg and 75 μg, as well as placebo. During the multiple-dose period, participants will receive either ALTO-203 25 μg, 75 μg , or placebo. Safety will be assessed over the single dose and 28-day multiple dose periods.
Key facts
- Study ID
- NCT06391593
- Run by
- Alto Neuroscience
- People needed
- 69
- Starts
- 2024-03-25
- Expected to finish
- 2025-04-21
- Last updated by the study team
- 2026-04-17
Who can join
Age: 25 and older, up to 64. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Site 4058 — Tucson, Arizona, United States
- Site 4082 — Oceanside, California, United States
- Site 4023 — Torrance, California, United States
- Site 4059 — Clermont, Florida, United States
- Site 4005 — Orlando, Florida, United States
- Site 4031 — Atlanta, Georgia, United States
- Site 4054 — Pikesville, Maryland, United States
- Site 4036 — Las Vegas, Nevada, United States
- Site 4022 — Marlton, New Jersey, United States
- Site 4134 — Princeton, New Jersey, United States
- Site 4075 — Westlake, Ohio, United States
- Site 4040 — Austin, Texas, United States
- Site 4072 — Houston, Texas, United States
- Site 4007 — Clinton, Utah, United States
- Site 4033 — Bellevue, Washington, United States
Full record on ClinicalTrials.gov
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