Anxiety & Depression Association of America

Study of ALTO-300 in MDD

Purpose

The purpose of this study is to determine efficacy differences between ALTO-300 and placebo, used adjunctively to an antidepressant, related to patient characteristics.

Condition

Major Depressive Disorder

Eligibility

Eligible Ages: Between 18 Years and 70 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Have a diagnosis of moderate to severe major depressive disorder (MDD) - At Visit 2, currently taking a single SSRI, SNRI, 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 - Nightly use of sleep medication - Diagnosed bipolar disorder, psychotic disorder, or dementia - Current moderate or severe substance use disorder - Has a history of hypersensitivity or allergic reaction to ALTO-300 or any of its components/excipients - Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental ALTO-300	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).	Drug: ALTO-300 ALTO-300 capsule QD
Placebo Comparator Placebo	Participants will receive matching placebo capsule once daily in the evening, from Day 1 to Day 42 in double blind (DB) treatment period.	Drug: Placebo Placebo capsule QD

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Alto Neuroscience

Study Contact

Alto Neuroscience
650-200-0412
clinical@altoneuroscience.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.