Phase 2b Study of ALTO-100 in MDD

Alto Neuroscience

Status and phase: Active, not recruiting; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: ALTO-100; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05712187

ALTO-100-201

Details and patient eligibility

About

The purpose of this study is to determine efficacy differences between ALTO-100 and placebo, used either as monotherapy or adjunctively to an antidepressant, related to patient characteristics.

Enrollment: 301 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a diagnosis of moderate to severe major depressive disorder (MDD)
• At baseline, either not taking an antidepressant medication, or currently taking a single SSRI, SNRI, mirtazapine, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks
• Willing to comply with all study assessments and procedures
• Must not be pregnant or breastfeeding at time of enrollment or throughout study

Exclusion criteria

• Evidence of unstable medical condition
• Diagnosed bipolar disorder, psychotic disorder, or dementia
• Current moderate or severe substance use disorder
• Has a history of hypersensitivity or allergic reaction to ALTO-100 or any of its components/excipients
• Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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301 participants in 2 patient groups, including a placebo group

ALTO-100

Experimental group

Description:

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).

Treatment:

Drug: ALTO-100

Placebo DB

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo