ALTO-100 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

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed 4 times over a 6 week interval, from day 1 to week 6

Summary

This trial is testing ALTO-100, a new treatment for depression, to see if it works better than other treatments. It will be used alone or with other antidepressants to find out if it helps reduce symptoms of depression.

Who is the study for?

This trial is for adults with moderate to severe major depressive disorder (MDD). Participants can be on a stable dose of certain antidepressants or not on medication. They must not be pregnant, breastfeeding, have unstable medical conditions, substance use disorders, other mental health diagnoses like bipolar or psychotic disorders, dementia, or allergies to ALTO-100.

What is being tested?

The study is testing the effectiveness of ALTO-100 compared to a placebo in treating MDD. It will look at how well it works alone or alongside an existing antidepressant. The goal is to see if patient characteristics influence the outcome.

What are the potential side effects?

While specific side effects are not listed here, common side effects from treatments like ALTO-100 may include nausea, headache, sleep disturbances and potential allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed 4 times over a 6 week interval, from day 1 to week 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed 4 times over a 6 week interval, from day 1 to week 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed 4 times over a 6 week interval, from day 1 to week 6 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 ALTO-100 versus placebo on symptoms of MDD in a pre-defined subgroup of participants as measured by the change from Day 1 to Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.

Secondary study objectives

To assess efficacy of ALTO-100 versus placebo for MDD as measured by the change from Day 1 to Week 6 in Clinician Global Impression Scale-severity (CGI-S).

To assess efficacy of ALTO-100 versus placebo for MDD as measured by the change from Day 1 to Week 6 in Patient Health Questionnaire, 9 item (PHQ-9).

To assess efficacy of ALTO-100 versus placebo for symptoms of MDD in a pre-defined subgroup of participants who are taking ALTO-100 as monotherapy for MDD as measured by the change from Day 1 to Week 6 on the MADRS total score.

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Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ALTO-100Experimental Treatment1 Intervention

Participants will receive ALTO-100 tablet twice daily, 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-100 tablet twice daily from OL baseline until the end of OL period/early termination visit (Up to 7 weeks).

Group II: Placebo DBPlacebo Group1 Intervention

Participants will receive matching placebo tablet twice daily, from Day 1 to Day 42 in double blind (DB) treatment period.

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