COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-03-25
Study Completion:2025-04-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06391593

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.

Ages Eligible for Study:25 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have a diagnosis of moderate major depressive disorder (MDD)
  2. * Presence of anhedonia symptoms
  3. * Not taking antidepressant at Screening Visit 2
  4. * Willing to comply with all study assessments and procedures
  1. * Evidence of unstable medical condition
  2. * Diagnosed bipolar disorder, psychotic disorder, or dementia
  3. * Concurrent use of prohibited medications
  4. * Current moderate or severe substance use disorder
  5. * Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device

Contacts and Locations

Study Locations (Sites)

Site 4058
Tucson, Arizona, 85704
United States
Site 4082
Oceanside, California, 92056
United States
Site 4023
Torrance, California, 90504
United States
Site 4059
Clermont, Florida, 34711
United States
Site 4005
Orlando, Florida, 32801
United States
Site 4031
Atlanta, Georgia, 30030
United States
Site 4054
Pikesville, Maryland, 21208
United States
Site 4036
Las Vegas, Nevada, 89121
United States
Site 4022
Marlton, New Jersey, 08053
United States
Site 4134
Princeton, New Jersey, 08540
United States
Site 4075
Westlake, Ohio, 44145
United States
Site 4040
Austin, Texas, 78737
United States
Site 4072
Houston, Texas, 77081
United States
Site 4007
Clinton, Utah, 84015
United States
Site 4033
Bellevue, Washington, 98007
United States

Collaborators and Investigators

Sponsor: Alto Neuroscience

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-25
Study Completion Date2025-04-21

Study Record Updates

Study Start Date2024-03-25
Study Completion Date2025-04-21

Terms related to this study

Additional Relevant MeSH Terms

  • Major Depressive Disorder
  • Anhedonia