ALTO-100 in MDD and/or PTSD

Phase 2

Completed

• Conditions: Major Depressive Disorder; Post Traumatic Stress Disorder
• Interventions: Drug: ALTO-100 PO tablet

• Registration Number: NCT05117632
• Lead Sponsor: Alto Neuroscience

Brief Summary

The goal of this study is to collect biologically based data for defining predictors and correlates of the effects of ALTO-100.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-02
• Study First Submitted QC: 2021-11-02
• Study First Posted: 2021-11-11
• Study Start: 2021-12-20
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-09
• Status Verified: 2023-11
• Disposition First Submitted: 2023-11-29
• Last Update Submitted: 2023-11-29
• Disposition First Posted: 2023-12-01
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

Inclusion Criteria

• Have a diagnosis of moderate to severe major depressive disorder (MDD) and/or post-traumatic stress disorder (PTSD)
• At baseline, either not taking an antidepressant medication, or currently taking a 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 cardiovascular, respiratory, liver, or renal impairment or disease
• Active suicidal ideation
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ALTO-100	ALTO-100 PO tablet	ALTO-100 PO tablet, daily dosing 8 weeks

Primary Outcome Measures

Name	Time	Method
To understand the relationship between baseline biology and clinical outcome with ALTO-100 using the Clinical Global Impression scale - Severity (CGI-S)	Measured 5 times over 8 weeks	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 change from baseline to the end of the study is the primary outcome.
Number of Participants With Clinically Significant Vital Signs Abnormalities as a Measure of Safety and Tolerability of ALTO-100	From the signing of the ICF until the end-of-treatment visit (up to 11 weeks)	Vital signs measured include blood pressure, heart rate, respiratory rate, temperature, and weight.
To understand the relationship between baseline biology and clinical outcome with ALTO-100 using the Montgomery-Åsberg Depression Rating Scale (MADRS)	Measured 5 times over 8 weeks	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 change from baseline to the end of the study is the primary outcome.
To understand the relationship between baseline biology and clinical outcome with ALTO-100 using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)	Measured 3 times over 8 weeks	The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) measures the severity of PTSD where smaller scores indicate less severe PTSD and higher scores suggest more severe PTSD. Possible scores for this 30 item version range from 0 to 120. The change from baseline to the end of the study is the primary outcome.
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability of ALTO-100	From the signing of the ICF until the follow-up visit (up to 12 weeks)	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.
Number of Participants With Clinically Significant Laboratory Abnormalities as a Measure of Safety and Tolerability of ALTO-100	From the signing of the ICF until the end-of-treatment visit (up to 11 weeks)	Blood samples for serum chemistry and hematology will be collected for clinical laboratory testing.

Trial Locations

Locations (22)

Site 139; 🇺🇸 Little Rock, Arkansas, United States

Site 150; 🇺🇸 Boca Raton, Florida, United States

Site 151; 🇺🇸 Baltimore, Maryland, United States

Site 120; 🇺🇸 Houston, Texas, United States

Site 113; 🇺🇸 Houston, Texas, United States

Site 105; 🇺🇸 Seattle, Washington, United States

Site 136; 🇺🇸 Tempe, Arizona, United States

Site 141; 🇺🇸 Costa Mesa, California, United States

Site 118; 🇺🇸 Fresno, California, United States

Site 116; 🇺🇸 Mather, California, United States

Site 112; 🇺🇸 Doral, Florida, United States

Site 155; 🇺🇸 Elgin, Illinois, United States

Site 137; 🇺🇸 Noblesville, Indiana, United States

Site 109; 🇺🇸 Belmont, Massachusetts, United States

Site 142; 🇺🇸 Lincoln, Nebraska, United States

Site 144; 🇺🇸 Las Vegas, Nevada, United States

Site 147; 🇺🇸 Fort Worth, Texas, United States

Site 148; 🇺🇸 Fort Worth, Texas, United States

Site 146; 🇺🇸 Middleburg Heights, Ohio, United States

Site 121; 🇺🇸 Draper, Utah, United States

NTC Seattle (105a); 🇺🇸 Tacoma, Washington, United States

Site 108; 🇺🇸 Jackson, Mississippi, United States