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ALTO-203 for Depression

Phase 2

Recruiting

Research Sponsored by Alto Neuroscience

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of anhedonia symptoms

Have a diagnosis of moderate major depressive disorder (MDD)

Must not have

Evidence of unstable medical condition

Concurrent use of prohibited medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up single-dose treatment period - pre-dose, 1.5 hours, 3 hours, and 5 hours on day 1 at treatments 1, 2, and 3

Summary

This trial aims to study the effects of ALTO-203 in patients with Major Depressive Disorder (MDD) through two treatment periods. In the first period, participants will receive a single dose of

Who is the study for?

This trial is for individuals with Major Depressive Disorder (MDD), particularly those experiencing anhedonia and depression. Participants will be involved in a study assessing the effects of a new treatment over single and multiple doses.

What is being tested?

The trial is testing ALTO-203 at two different strengths, 25 μg and 75 μg, against a placebo. It aims to understand how the drug works (pharmacodynamics), its safety, tolerability, and movement through the body (pharmacokinetics) over both single-dose and multi-dose periods.

What are the potential side effects?

Potential side effects are not specified but will be monitored throughout the trial. These may include typical drug-related reactions such as nausea, headaches, or other responses that participants might experience from taking ALTO-203.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience a lack of pleasure in activities I once enjoyed.

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I have been diagnosed with moderate depression.

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I am not taking antidepressants.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a health condition that is not stable.

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I am not taking any medications that are not allowed in the study.

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I am currently in, or recently finished, a trial for mental illness using new treatments or devices.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ single-dose treatment period - pre-dose, 1.5 hours, 3 hours, and 5 hours on day 1 at treatments 1, 2, and 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~single-dose treatment period - pre-dose, 1.5 hours, 3 hours, and 5 hours on day 1 at treatments 1, 2, and 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and single-dose treatment period - pre-dose, 1.5 hours, 3 hours, and 5 hours on day 1 at treatments 1, 2, and 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Multi-Dose Period: To assess the incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] during the multi-dose treatment period for ALTO-203 25 μg and ALTO-203 75 μg as compared to placebo.

Single Dose Period: To evaluate pharmacodynamic measures in patients with MDD after single doses of 25 μg ALTO-203, 75 μg ALTO-203, and placebo as measured by the alertness and mood components of the Bond-Lader Visual Analog Scale (BL-VAS).

Secondary study objectives

Multi-Dose Period: To understand the pharmacokinetics (PK) of multi-doses of ALTO-203 in capsule formulation

Single Dose Period: To assess the incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] during the single-dose treatment period for ALTO-203 25 μg and ALTO-203 75 μg as compared to placebo.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: ALTO-203 75 μgExperimental Treatment1 Intervention

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

Group II: ALTO-203 25 μgExperimental Treatment1 Intervention

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

Group III: PlaceboPlacebo Group1 Intervention

Drug: Placebo Single-Dose Treatment Period: Single Dose, Placebo Multi-Dose Treatment Period: Placebo, administered orally, once daily for 28 days

0 / 6Eligibility criteria met