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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05117632
Other study ID # ALTO-100-001
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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)
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