ALTO-300 in Depression

NCT05118750 | Completed Phase 2 FDA Drug

• 1 other identifier: ALTO-300-002
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (4)

• To understand the relationship between baseline biology and clinical outcome to ALTO-300 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.

  Measured 6 times over 8 weeks

• To understand the relationship between baseline biology and clinical outcome to ALTO-300 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.

  Measured 6 times over 8 weeks

• To evaluate the safety of ALTO-300

  Incidence, severity, and relatedness of TEAEs,SAEs, discontinuation due to TEAEs, and deaths

  From the signing of the ICF until the follow-up visit (up to 12 weeks)

• To evaluate the safety of ALTO-300

  Assessment of vital signs and laboratory data, withparticular attention to liver function tests

  From the signing of the ICF until the end-of-treatment visit (up to 11 weeks)

Study Arms (1)

ALTO-300

EXPERIMENTAL

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

Drug: ALTO-300 oral (PO) tablet

Interventions

ALTO-300 oral (PO) tablet DRUG

One tablet daily

ALTO-300

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alto Neuroscience: lead

Study Sites (11)

Site 153

Culver City, California, 90230, United States

Location

Site 103

Sacramento, California, 95757, United States

Location

Site 158

Santee, California, 92071, United States

Location

Site 159

Clermont, Florida, 34711, United States

Location

Site 161

Okeechobee, Florida, 34972, United States

Location

Site 137

Noblesville, Indiana, 46060, United States

Location

Site 166

Saint Charles, Missouri, 63304, United States

Location

Site 132

New York, New York, 10023, United States

Location

Site 102

Dallas, Texas, 75235, United States

Location

Site 165

DeSoto, Texas, 75115, United States

Location

Site 147

Fort Worth, Texas, 76104, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Tablets

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: November 12, 2021
• Study Start: December 13, 2021
• Primary Completion: May 5, 2023
• Study Completion: May 9, 2023
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

US (11)