ALTO-100 in MDD and/or PTSD

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05117632
• Other study ID #: ALTO-100-001
• Status: Completed
• Phase: Phase 2
• Start date: December 20, 2021
• Est. completion date: December 9, 2022

Study information

• Verified date: November 2023
• Source: Alto Neuroscience
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: December 9, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• ALTO-100 PO tablet
one tablet twice daily

Locations

Country	Name	City	State
United States	Site 151	Baltimore	Maryland
United States	Site 109	Belmont	Massachusetts
United States	Site 150	Boca Raton	Florida
United States	Site 141	Costa Mesa	California
United States	Site 112	Doral	Florida
United States	Site 121	Draper	Utah
United States	Site 155	Elgin	Illinois
United States	Site 147	Fort Worth	Texas
United States	Site 148	Fort Worth	Texas
United States	Site 118	Fresno	California
United States	Site 113	Houston	Texas
United States	Site 120	Houston	Texas
United States	Site 108	Jackson	Mississippi
United States	Site 144	Las Vegas	Nevada
United States	Site 142	Lincoln	Nebraska
United States	Site 139	Little Rock	Arkansas
United States	Site 116	Martinez	California
United States	Site 116	Mather	California
United States	Site 146	Middleburg Heights	Ohio
United States	Site 137	Noblesville	Indiana
United States	Site 105	Seattle	Washington
United States	NTC Seattle (105a)	Tacoma	Washington
United States	Site 136	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Alto Neuroscience

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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)
Primary	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)