ALTO-300 in Depression

Recruiting at 10 trial locations

Overseen By Lesley Parker

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Alto Neuroscience

Must be taking: SSRI, SNRI, Bupropion

Must not be taking: TCAs, MAOIs, Antipsychotics, others

Disqualifiers: Liver disease, Bipolar, Psychotic disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

91 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

You can continue taking your current SSRI, SNRI, or bupropion if you've been on a stable dose for at least 6 weeks. However, you cannot use certain other medications like tricyclic antidepressants, melatonin, or antipsychotics during the trial.

How does the drug ALTO-300 (Agomelatine) differ from other treatments for its condition?

Agomelatine is unique because it works by activating melatonin receptors and blocking certain serotonin receptors, which helps regulate sleep patterns and mood. This dual action is different from most traditional antidepressants and can improve sleep quality with fewer side effects. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial studies ALTO-300, a treatment, to understand its effects on various patients. Researchers aim to find indicators that show how effective ALTO-300 is.

Eligibility Criteria

Inclusion Criteria

Have a diagnosis of moderate to severe major depressive disorder

I am willing to comply with all study assessments and procedures.

A woman is not allowed to be pregnant or breastfeeding at the time of enrollment or throughout the study.

Exclusion Criteria

You have a serious problem with alcohol.

You are currently having thoughts of wanting to harm yourself.

Evidence of liver impairment or disease

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks

Treatment

Participants receive ALTO-300 oral tablet daily for 8 weeks

8 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 weeks

Treatment Details

Interventions

• ALTO-300

Participant Groups

Group I: ALTO-300 Experimental Treatment 1 Intervention

ALTO-300 oral (PO) tablet; daily dosing 8 weeks

ALTO-300 is already approved in European Union for the following indications:

Approved in European Union as Valdoxan for:

• Major Depressive Disorder

Who Is Running the Clinical Trial?

Alto Neuroscience

Lead Sponsor

Trials

11

Recruited

1,300+

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of agomelatine in generalized anxiety disorder: a randomized, double-blind, placebo-controlled study. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Synergistic mechanisms involved in the antidepressant effects of agomelatine. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Agomelatine: a preliminary review of a new antidepressant. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Blockade of stress-induced increase of glutamate release in the rat prefrontal/frontal cortex by agomelatine involves synergy between melatonergic and 5-HT2C receptor-dependent pathways. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Agomelatine as monotherapy for major depression: an outpatient, open-label study. [2021]