Pilot Decentralized Trial

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

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-01-26

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-100.

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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-100

ALTO-100 tablet PO ; twice daily dosing 8 weeks

Group Type EXPERIMENTAL

ALTO-100 PO Tablet

Intervention Type DRUG

Two tablets daily

Interventions

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ALTO-100 PO Tablet

Two tablets daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have a diagnosis of moderate to severe major depressive disorder
* Either currently taking a SSRI, SNRI, mirtazapine, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks, or are not taking an antidepressant medication
* Willing to comply with all study assessments and procedures
* Must not be pregnant or breastfeeding at time of enrollment or throughout study
* Must have access with privacy to a computer with a keyboard and internet

Exclusion Criteria

* Evidence of acute or unstable cardiovascular, respiratory, hepatic, or other major disease
* Active suicidal ideation
* Severe impediment to vision, hearing, and/or hand movement
* Diagnosed bipolar disorder or psychotic 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

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No