ALTO-100 in MDD and/or PTSD

An Open-label Study of ALTO-100 in Adults With Major Depressive Disorder and/or Post-traumatic Stress Disorder

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

Study Overview

• Status: Completed
• Conditions: Post Traumatic Stress Disorder; Major Depressive Disorder
• Intervention / Treatment: Drug: ALTO-100 PO tablet

• Study Type: Interventional
• Enrollment (Actual): 245
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85284
      • Site 136
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Site 139
  • California
    • Costa Mesa, California, United States, 92626
      • Site 141
    • Fresno, California, United States, 93703
      • Site 118
    • Martinez, California, United States, 94553
      • Site 116
    • Mather, California, United States, 95655
      • Site 116
  • Florida
    • Boca Raton, Florida, United States, 33431
      • Site 150
    • Doral, Florida, United States, 33172
      • Site 112
  • Illinois
    • Elgin, Illinois, United States, 60123
      • Site 155
  • Indiana
    • Noblesville, Indiana, United States, 46060
      • Site 137
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • Site 151
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • Site 109
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Site 108
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Site 142
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Site 144
  • Ohio
    • Middleburg Heights, Ohio, United States, 44130
      • Site 146
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Site 147
    • Fort Worth, Texas, United States, 76244
      • Site 148
    • Houston, Texas, United States, 77054
      • Site 120
    • Houston, Texas, United States, 77090
      • Site 113
  • Utah
    • Draper, Utah, United States, 84020
      • Site 121
  • Washington
    • Seattle, Washington, United States, 98104
      • Site 105
    • Tacoma, Washington, United States, 98104
      • NTC Seattle (105a)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ALTO-100; ALTO-100 PO tablet, daily dosing 8 weeks	Drug: ALTO-100 PO tablet; one tablet twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To understand the relationship between baseline biology and clinical outcome with ALTO-100 using the Montgomery-Åsberg Depression Rating Scale (MADRS)	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.	Measured 5 times over 8 weeks
To understand the relationship between baseline biology and clinical outcome with ALTO-100 using the Clinical Global Impression scale - Severity (CGI-S)	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.	Measured 5 times over 8 weeks
To understand the relationship between baseline biology and clinical outcome with ALTO-100 using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)	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.	Measured 3 times over 8 weeks
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 12 weeks)
Number of Participants With Clinically Significant Vital Signs Abnormalities as a Measure of Safety and Tolerability of ALTO-100	Vital signs measured include blood pressure, heart rate, respiratory rate, temperature, and weight.	From the signing of the ICF until the end-of-treatment visit (up to 11 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 11 weeks)

Collaborators and Investigators

• Sponsor: Alto Neuroscience

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2021
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 9, 2022

Study Registration Dates

• First Submitted: November 2, 2021
• First Submitted That Met QC Criteria: November 2, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Trauma and Stressor Related Disorders; Depression; Depressive Disorder; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Depressive Disorder, Major
• Other Study ID Numbers: ALTO-100-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No