ALTO-100 in MDD and/or PTSD

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

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

Conditions
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Major Depressive Disorder, Post Traumatic Stress Disorder

Intervention / Treatment
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* Drug: ALTO-100 PO tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALTO-100<br>ALTO-100 PO tablet, daily dosing 8 weeks | Drug: ALTO-100 PO tablet<br>* one tablet twice daily<br>|

What is the study measuring?
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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) |