ALTO-100 in MDD and/or PTSD

NCT05117632 | Completed Phase 2 FDA Drug

• 1 other identifier: ALTO-100-001
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 23

Brief Summary

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

Conditions

Major Depressive Disorder; Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (6)

• 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)

Study Arms (1)

ALTO-100

EXPERIMENTAL

ALTO-100 PO tablet, daily dosing 8 weeks

Drug: ALTO-100 PO tablet

Interventions

ALTO-100 PO tablet DRUG

one tablet twice daily

ALTO-100

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alto Neuroscience: lead

Study Sites (23)

Site 136

Tempe, Arizona, 85284, United States

Location

Site 139

Little Rock, Arkansas, 72211, United States

Location

Site 141

Costa Mesa, California, 92626, United States

Location

Site 118

Fresno, California, 93703, United States

Location

Site 116

Martinez, California, 94553, United States

Location

Site 116

Mather, California, 95655, United States

Location

Site 150

Boca Raton, Florida, 33431, United States

Location

Site 112

Doral, Florida, 33172, United States

Location

Site 155

Elgin, Illinois, 60123, United States

Location

Site 137

Noblesville, Indiana, 46060, United States

Location

Site 151

Baltimore, Maryland, 21229, United States

Location

Site 109

Belmont, Massachusetts, 02478, United States

Location

Site 108

Jackson, Mississippi, 39216, United States

Location

Site 142

Lincoln, Nebraska, 68526, United States

Location

Site 144

Las Vegas, Nevada, 89102, United States

Location

Site 146

Middleburg Heights, Ohio, 44130, United States

Location

Site 147

Fort Worth, Texas, 76104, United States

Location

Site 148

Fort Worth, Texas, 76244, United States

Location

Site 120

Houston, Texas, 77054, United States

Location

Site 113

Houston, Texas, 77090, United States

Location

Site 121

Draper, Utah, 84020, United States

Location

Site 105

Seattle, Washington, 98104, United States

Location

NTC Seattle (105a)

Tacoma, Washington, 98104, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 11, 2021
• Study Start: December 20, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 9, 2022
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

US (23)