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ALTO-203 75 μg for Anhedonia

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)
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

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

Find a Location

Who is running the clinical trial?

Alto NeuroscienceLead Sponsor
8 Previous Clinical Trials
971 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which specific criteria determine the eligibility of individuals for participation in this clinical trial?

"Individuals aged between 25 and 64 who present symptoms of anhedonia are sought to participate in this research initiative. Approximately 60 eligible participants are being sought for inclusion."

Answered by AI

What is the current number of individuals involved in this clinical trial as participants?

"To complete the enrollment for this research, 60 eligible individuals are needed. Participation is open at various locations, such as Site 4023 in Torrance, California and Site 4082 in Oceanside, Florida."

Answered by AI

Is there an inclusion of individuals aged 85 and older in this clinical study?

"Eligible participants for this research study range from 25 to 64 years old. It is worth noting that there are 238 trials focused on individuals under 18, and a further 1053 studies targeting those above the age of 65."

Answered by AI

Is the current investigation open for participant enrollment?

"Indeed, information retrieved from clinicaltrials.gov confirms the active recruitment of participants for this study. The trial was initially listed on March 25th, 2024 and last modified on April 25th, 2024. There is a need to enroll 60 individuals distributed among ten distinct sites."

Answered by AI

Are multiple medical centers conducting this scientific investigation in North America?

"Enrollment opportunities are available for this clinical trial at various sites, including Site 4023 in Torrance, Site 4082 in Oceanside, and Site 4059 in Clermont. Additionally, there are openings at ten other undisclosed locations."

Answered by AI

Who else is applying?

What site did they apply to?
Site 4031
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
PD, PK, and Safety of ALTO-203 in Patients With MDD
2024. "PD, PK, and Safety of ALTO-203 in Patients With MDD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06391593.
All > Depression Baltimore > Paid Studies Pasadena
~40 spots leftby Apr 2025
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