ALTO-100 in MDD and/or PTSD

NCT ID: NCT05117632

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-20

Study Completion Date

2022-12-09

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.

Detailed Description

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Conditions

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Major Depressive Disorder Post Traumatic Stress Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ALTO-100

ALTO-100 PO tablet, daily dosing 8 weeks

Group Type EXPERIMENTAL

ALTO-100 PO tablet

Intervention Type DRUG

one tablet twice daily

Interventions

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ALTO-100 PO tablet

one tablet twice daily

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alto Neuroscience

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Site 136

Tempe, Arizona, United States

Site Status

Site 139

Little Rock, Arkansas, United States

Site Status

Site 141

Costa Mesa, California, United States

Site Status

Site 118

Fresno, California, United States

Site Status

Site 116

Martinez, California, United States

Site Status

Site 116

Mather, California, United States

Site Status

Site 150

Boca Raton, Florida, United States

Site Status

Site 112

Doral, Florida, United States

Site Status

Site 155

Elgin, Illinois, United States

Site Status

Site 137

Noblesville, Indiana, United States

Site Status

Site 151

Baltimore, Maryland, United States

Site Status

Site 109

Belmont, Massachusetts, United States

Site Status

Site 108

Jackson, Mississippi, United States

Site Status

Site 142

Lincoln, Nebraska, United States

Site Status

Site 144

Las Vegas, Nevada, United States

Site Status

Site 146

Middleburg Heights, Ohio, United States

Site Status

Site 147

Fort Worth, Texas, United States

Site Status

Site 148

Fort Worth, Texas, United States

Site Status

Site 120

Houston, Texas, United States

Site Status

Site 113

Houston, Texas, United States

Site Status

Site 121

Draper, Utah, United States

Site Status

Site 105

Seattle, Washington, United States

Site Status

NTC Seattle (105a)

Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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ALTO-100-001

Identifier Type: -

Identifier Source: org_study_id