ALTO-300 in Depression

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

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-13

Study Completion Date

2023-05-09

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.

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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-300

ALTO-300 oral (PO) tablet; daily dosing 8 weeks

Group Type EXPERIMENTAL

ALTO-300 oral (PO) tablet

Intervention Type DRUG

One tablet daily

Interventions

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ALTO-300 oral (PO) tablet

One tablet daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* have a diagnosis of MDD based on the Structured Clinical Interview for DSM-5 (SCID) for depression
* have moderate to severe depression on DSM-5 depression criteria items, as assessed by a score of ≥10 on the Patient Health Questionnaire-9 (PHQ-9) at each of Visits 1, 2, and 3
* at baseline (Visit 2) are taking a stable dose of a single SSRI, serotonin-norepinephrine reuptake inhibitor (SNRI), or bupropion and have been on that medication for ≥6 weeks at an adequate dosage defined by the Antidepressant Treatment Response Questionnaire (ATRQ), and with no modification to dosage for ≥2 weeks.
* have either: had a continuous period of euthymia of at least 2 months in the past 26 months, regardless of the number of failed antidepressants OR not had a period of euthymia of at least 2 months in the past 26 months but within the past 24 months have not failed \>3 antidepressants at an adequate dosage and duration as defined by the ATRQ
* are currently on their last failed currently prescribed permitted baseline antidepressant medication
* have a response to their currently prescribed antidepressant noted as depression that has improved ≤49% as defined by the ATRQ.
* agree to, and are eligible for all biomarker assessments (EEG, neurocognitive testing, activity and sleep monitoring, genetic testing). To participate in the activity and sleep monitoring biomarkers, all participants will be required to have a smart phone or an internet enabled tablet. A participant who otherwise qualifies may refuse the salivary genetic sample and be included in the study.
* fluent in English
* willing to comply with all study procedures (with the notes above), able to complete all assessments independently, and available for the duration of the study.

Exclusion Criteria

Any of the following medical conditions:

* hepatic impairment (i.e., cirrhosis or active/chronic liver disease)
* baseline serum transaminase levels that exceed 2x upper limit of normal(ULN)
* severe impediment to vision, hearing, comprehension, and/or hand movement that interferes with study tasks.
* any contraindications to EEG (i.e., requiring high concentration oxygen)
* active suicidal ideation as assessed by the investigator.
* moderate to severe Alcohol Use Disorder (AUD)

Concurrent use of any of the following at baseline (Visit 2):

* tricyclic antidepressants (TCAs), mirtazapine, or monoamine oxidase inhibitors (MAOIs)
* melatonin, ramelteon, or other melatonin agonist
* a potent CYP1A2 inhibitor (e.g., fluvoxamine and ciprofloxacin)
* antipsychotics or mood stabilizers
* hypnotics, anxiolytics, stimulants, or opiate pain medications greater than three days per week and unable to reduce use to 3 or fewer days per week on an as needed basis

Have received electroconvulsive therapy (ECT), deep brain stimulation (DBS),vagus nerve stimulation (VNS), \>2 treatments with ketamine, or esketamine in thecurrent depressive episode.

Diagnosis of bipolar disorder or a psychotic disorder based on the SCID forDSM-5

Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No