ALTO-300 in Depression (ALTO-300-004)

NCT ID: NCT05157945

Last Updated: 2024-04-26

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

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-03

Study Completion Date

2023-05-05

Brief Summary

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The purpose of this study is to collect biologically-based data for defining predictors and correlates of the effects of ALTO-300.

Detailed Description

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Conditions

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Major Depressive 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-300

ALTO-300 tablet PO; daily dosing 8 weeks

Group Type EXPERIMENTAL

ALTO-300 PO Tablet

Intervention Type DRUG

One tablet daily

Interventions

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ALTO-300 PO Tablet

One tablet daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have a diagnosis of moderate to severe major depressive disorder
* Currently taking a SSRI, SNRI, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks
* Must have failed to adequately respond to the current antidepressant medication
* 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 liver impairment or disease
* Active suicidal ideation
* Moderate to severe Alcohol Use Disorder
* Diagnosed bipolar disorder or psychotic disorder
* Has a history of hypersensitivity or allergic reaction to ALTO-300 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

74 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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Cerebral - Atlanta

Atlanta, Georgia, United States

Site Status

Site 171

Jackson, Mississippi, United States

Site Status

Cerebral - New York City

New York, New York, United States

Site Status

Cerebral - Dallas

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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ALTO-300-004

Identifier Type: -

Identifier Source: org_study_id

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