Pilot Decentralized Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect biologically-based data for defining predictors and correlates of the effects of ALTO-100.

Official Title
-----------------
An Open-Label Study of ALTO-100 in Adults With Major Depressive Disorder (MDD)

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: ALTO-100 PO Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a diagnosis of moderate to severe major depressive disorder Either currently taking a SSRI, SNRI, mirtazapine, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks, or are not taking an antidepressant medication Willing to comply with all study assessments and procedures Must not be pregnant or breastfeeding at time of enrollment or throughout study Must have access with privacy to a computer with a keyboard and internet Exclusion Criteria: Evidence of acute or unstable cardiovascular, respiratory, hepatic, or other major disease Active suicidal ideation Severe impediment to vision, hearing, and/or hand movement Diagnosed bipolar disorder or psychotic 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALTO-100<br>ALTO-100 tablet PO ; twice daily dosing 8 weeks | Drug: ALTO-100 PO Tablet<br>* Two tablets daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To understand the relationship between baseline biology and score change in the Montgomery-Asberg Depression Rating Scale (MADRS) with ALTO-100 from start of dosing to end of treatment | The Montgomery-Åsberg Depression Rating Scale (MADRS) measures the severity of depression where smaller scores indicate less depression and higher scores suggest more severe depression. Possible scores for this 10 item version range from 0 to 60. The score change from the start of dosing (Day 1) to the end of treatment (Day 56) is the primary outcome. | Measured at Day 1, Day 14, Day 28, Day 42, Day 56 | 
| To understand the relationship between baseline biology and score change in the Clinical Global Impression scale - Severity (CGI-S) with ALTO-100 from Screening to end of treatment | The Clinical Global Impression scale - Severity (CGI-S) measures the severity of psychopathology in general where smaller scores indicate less illness and higher scores suggest more severe illness. Possible scores for this scale range from 1 to 7. The score change from Screening (Day [-21]) to the end of treatment (Day 56) is the primary outcome. | Measured at Screening, Day 1, Day 14, Day 28, Day 42, Day 56 | 
| Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability of ALTO-100 | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | From the signing of the ICF until the follow-up visit (up to 13 weeks) | 
| Number of Participants With Clinically Significant Laboratory Abnormalities as a Measure of Safety and Tolerability of ALTO-100 | Blood samples for serum chemistry and hematology will be collected for clinical laboratory testing. | From the signing of the ICF until the end-of-treatment visit (up to 13 weeks) |