Anxiety & Depression Association of America

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

Purpose

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

Eligibility

Eligible Ages: Between 25 Years and 64 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The study will consist of two treatment periods. The initial Single-Dose Treatment Period is a randomized, double-blind, placebo-controlled 3-way crossover design with oral administration of a single dose of ALTO-203 25 μg, ALTO-203 75 μg, and matching placebo. In the subsequent Multi-Dose Parallel-Group Treatment Period, participants will receive ALTO-203 25 μg, ALTO-203 75 μg, or matching placebo randomized 1:1:1 for a total of 28 days.
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental ALTO-203 25 μg	Drug: ALTO-203 25 μg Single-Dose Treatment Period: Single Dose, ALTO-203 25 μg Multi-Dose Treatment Period: ALTO-203 25 μg, administered orally, once daily for 28 days	Drug: ALTO-203 25 μg Active, ALTO-203 25 μg
Experimental ALTO-203 75 μg	Drug: ALTO-203 75 μg Single-Dose Treatment Period: Single Dose, ALTO-203 75 μg Multi-Dose Treatment Period: ALTO-203 75 μg, administered orally, once daily for 28 days	Drug: ALTO-203 75 μg Active, ALTO-203 75 μg
Placebo Comparator Placebo	Drug: Placebo Single-Dose Treatment Period: Single Dose, Placebo Multi-Dose Treatment Period: Placebo, administered orally, once daily for 28 days	Drug: Placebo Comparator, Placebo-to-match

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Alto Neuroscience

Study Contact

Alto Neuroscience
650-200-0412
clinical@altoneuroscience.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.