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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
Awards & highlights

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 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

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Who is running the clinical trial?

Alto NeuroscienceLead Sponsor
9 Previous Clinical Trials
1,043 Total Patients Enrolled
~30 spots leftby Apr 2025
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