PD, PK, and Safety of ALTO-203 in Patients With MDD

Description

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.

Conditions

Major Depressive Disorder, Anhedonia

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Study Overview

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Study Details

Study overview

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.

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

PD, PK, and Safety of ALTO-203 in Patients With MDD

Condition
Major Depressive Disorder
Intervention / Treatment

-

Contacts and Locations

Tucson

Site 4058, Tucson, Arizona, United States, 85704

Oceanside

Site 4082, Oceanside, California, United States, 92056

Torrance

Site 4023, Torrance, California, United States, 90504

Clermont

Site 4059, Clermont, Florida, United States, 34711

Orlando

Site 4005, Orlando, Florida, United States, 32801

Atlanta

Site 4031, Atlanta, Georgia, United States, 30030

Pikesville

Site 4054, Pikesville, Maryland, United States, 21208

Las Vegas

Site 4036, Las Vegas, Nevada, United States, 89121

Berlin

Site 4022, Berlin, New Jersey, United States, 08009

Princeton

Site 4134, Princeton, New Jersey, United States, 08540

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

25 Years to 64 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alto Neuroscience,

Study Record Dates

2025-05