ALTO-100 in MDD and/or PTSD

Alto Neuroscience245 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

245

Conditions

Major Depressive Disorder Post Traumatic Stress Disorder

Interventions

ALTO-100 PO tabletDRUG

one tablet twice daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 69 Years

Medical Language ↔ Plain English

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

Locations (23)

Site 136

Tempe, Arizona, United States

Site 139

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Data from ClinicalTrials.gov

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