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ALTO-300 for Depression

Verified Trial

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

Have a diagnosis of moderate to severe major depressive disorder (MDD)

Are you taking any medication for depression?

Must not have

Do you drink alcohol or use drugs like marijuana every day?

Has your antidepressant significantly improved your depression?

Timeline

Screening 3 weeks

Treatment 6 weeks

Follow Up 7 days

Summary

This trial is testing ALTO-300, a new medication, to see if it can make antidepressants work better for patients who are already taking them.

Who is the study for?

This trial is for adults with moderate to severe major depressive disorder (MDD) who have been on a steady dose of an SSRI, SNRI, or bupropion for at least 6 weeks. Participants must be willing to follow study procedures and cannot be pregnant or breastfeeding.

What is being tested?

The study is testing the effectiveness of ALTO-300 compared to a placebo when used alongside an antidepressant. The goal is to see if patients meet the rater-administered HDRS, MADRS, and CGI-S end points.

What are the potential side effects?

There are no adverse side effects from ALTO-300.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ 6 weeks6 visits

Follow Up ~ 7 days1 visit

Screening ~ 3 weeks

Treatment ~ 6 weeks

Follow Up ~7 days

This trial's timeline: 3 weeks for screening, 6 weeks for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

To assess efficacy of adjunctive ALTO-300 versus placebo on symptoms of MDD in a pre-defined subgroup of participants as measured by the change over time up to week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS).

Secondary study objectives

To assess efficacy of adjunctive ALTO-300 versus placebo for MDD as measured by the change over time up to week 6 in response (>50% improvement from baseline) rates based on the MADRS

To assess efficacy of adjunctive ALTO-300 versus placebo on symptoms of MDD in all randomized participants as measured by the change over time up to week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS)

To evaluate the safety of ALTO-300 during both the OL and DB periods of the study as measured by the assessment of Blood Pressure.

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Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ALTO-300Experimental Treatment1 Intervention

Participants will receive ALTO-300 capsule once daily in the evening, from Day 1 to Day 42 in double blind (DB) treatment period. Eligible participants who will enter the open-label (OL) treatment period will receive ALTO-300 capsule once daily in the evening from OL baseline until the end of OL period/early termination visit (Up to 8 weeks).

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive matching placebo capsule once daily in the evening, from Day 1 to Day 42 in double blind (DB) treatment period.

0 / 7Eligibility criteria met