Pilot Decentralized Trial | NCT05419869 | Trialant

Pilot Decentralized Trial | NCT05419869 | Trialant

Arms/Interventions Module

Outcomes Module

Primary Outcomes

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)

Submission Tracking

Condition Browse Module