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

Last updated: August 5, 2024
Sponsor: Alto Neuroscience
Overall Status: Active - Recruiting

Phase

2

Condition

Depression (Adult And Geriatric)

Mood Disorders

Depression

Treatment

ALTO-203 75 μg

ALTO-203 25 μg

Placebo

Clinical Study ID

NCT06391593
ALTO-203-201
  • Ages 25-64
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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 illnessinvolving an investigational product or device

Study Design

Total Participants: 60
Treatment Group(s): 3
Primary Treatment: ALTO-203 75 μg
Phase: 2
Study Start date:
March 25, 2024
Estimated Completion Date:
May 31, 2025

Connect with a study center

  • Site 4058

    Tucson, Arizona 85704
    United States

    Active - Recruiting

  • Site 4082

    Oceanside, California 92056
    United States

    Active - Recruiting

  • Site 4023

    Torrance, California 90504
    United States

    Active - Recruiting

  • Site 4059

    Clermont, Florida 34711
    United States

    Active - Recruiting

  • Site 4005

    Orlando, Florida 32801
    United States

    Active - Recruiting

  • Site 4031

    Atlanta, Georgia 30030
    United States

    Active - Recruiting

  • Site 4054

    Pikesville, Maryland 21208
    United States

    Active - Recruiting

  • Site 4036

    Las Vegas, Nevada 89121
    United States

    Active - Recruiting

  • Site 4022

    Berlin, New Jersey 08009
    United States

    Active - Recruiting

  • Site 4134

    Princeton, New Jersey 08540
    United States

    Active - Recruiting

  • Site 4075

    Westlake, Ohio 44145
    United States

    Site Not Available

  • Site 4040

    Austin, Texas 78737
    United States

    Active - Recruiting

  • Site 4072

    Houston, Texas 77081
    United States

    Active - Recruiting

  • Site 4007

    Clinton, Utah 84015
    United States

    Active - Recruiting

  • Site 4033

    Bellevue, Washington 98007
    United States

    Active - Recruiting

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