Phase 2b Study of ALTO-100 in MDD

NCT05712187 | Completed Phase 2 FDA Drug

• 1 other identifier: ALTO-100-201
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 34

Brief Summary

The purpose of this study is to determine efficacy differences between ALTO-100 and placebo, used either as monotherapy or adjunctively to an antidepressant, related to patient characteristics.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• To assess efficacy of ALTO-100 versus placebo on symptoms of MDD in a pre-defined subgroup of participants as measured by the change from Day 1 to Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.

  MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

  Change assessed from Day 1 to Week 6

Secondary Outcomes (10)

• To assess efficacy of ALTO-100 versus placebo for symptoms of MDD in a pre-defined subgroup of participants who are taking ALTO-100 as monotherapy for MDD as measured by the change from Day 1 to Week 6 on the MADRS total score.

  Change assessed from Day 1 to Week 6

• To assess efficacy of ALTO-100 versus placebo on symptoms of MDD in all randomized participants as measured by the change from Day 1 to Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS)

  Assessed 4 times over a 6 week interval, from Day 1 to Week 6

• To assess efficacy of ALTO-100 versus placebo for MDD as measured by the change from Day 1 to Week 6 in Clinician Global Impression Scale-severity (CGI-S).

  Assessed 4 times over a 6 week interval, from Day 1 to Week 6

• To assess efficacy of ALTO-100 vs placebo for MDD as measured by the change from Day 1 to Week 6 in response (>50% improvement from baseline) and remission (total MADRS score of <10) rates based on the Montgomery-Åsberg Depression Rating Scale (MADRS)

  Assessed 4 times over a 6- week interval, from Day 1 to Week 6

• To assess efficacy of ALTO-100 versus placebo for MDD as measured by the change from Day 1 to Week 6 in Patient Health Questionnaire, 9 item (PHQ-9).

  Assessed 4 times over a 6- week interval, from Day 1 to Week 6

Study Arms (2)

ALTO-100

EXPERIMENTAL

Participants will receive ALTO-100 tablet twice daily, from Day 1 to Day 42 in double blind (DB) treatment period. Eligible participants who will enter the open label (OL) treatment period will receive ALTO-100 tablet twice daily from OL baseline until the end of OL period/early termination visit (Up to 7 weeks).

Drug: ALTO-100

Placebo DB

PLACEBO COMPARATOR

Participants will receive matching placebo tablet twice daily, from Day 1 to Day 42 in double blind (DB) treatment period.

Drug: Placebo

Interventions

ALTO-100 DRUG

ALTO-100 tablet BID

ALTO-100

Placebo DRUG

Placebo tablet BID

Placebo DB

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Have a diagnosis of moderate to severe major depressive disorder (MDD)
• At baseline, either not taking an antidepressant medication, or currently taking a single 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

You may not qualify if:

• Evidence of unstable medical condition
• 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

Sponsors & Collaborators

• Alto Neuroscience: lead

Study Sites (34)

Site 174

Birmingham, Alabama, 35294, United States

Location

Site 173

Huntsville, Alabama, 35801, United States

Location

Site 136

Chandler, Arizona, 85226, United States

Location

Site 139

Little Rock, Arkansas, 72211, United States

Location

Site 141

Costa Mesa, California, 92626, United States

Location

Site 118

Fresno, California, 93703, United States

Location

Site 181

Imperial, California, 92251, United States

Location

Site 182

Oceanside, California, 92056, United States

Location

Site 188

Oceanside, California, 92056, United States

Location

Site 179

Rancho Cucamonga, California, 91730, United States

Location

Site 116

Sacramento, California, 95655, United States

Location

Site 185

Centennial, Colorado, 80112, United States

Location

Site 186

Brooksville, Florida, 34613, United States

Location

Site 204

Jacksonville, Florida, 32256, United States

Location

Site 205

Orlando, Florida, 32801, United States

Location

Site 212

Tampa, Florida, 33629, United States

Location

Site 213

Tampa, Florida, 33629, United States

Location

Site 137

Carmel, Indiana, 46032, United States

Location

Site 151

Baltimore, Maryland, 21229, United States

Location

Site 108

Jackson, Mississippi, 39216, United States

Location

Site 171

Jackson, Mississippi, 39216, United States

Location

Site 142

Lincoln, Nebraska, 68562, United States

Location

Site 144

Las Vegas, Nevada, 89102, United States

Location

Site 178

Albuquerque, New Mexico, 87109, United States

Location

Site 184

Brooklyn, New York, 11229, United States

Location

Site 180

New York, New York, 10022, United States

Location

Site 210

New York, New York, 10128, United States

Location

Site 175

Westlake, Ohio, 44145, United States

Location

Site 157

North Charleston, South Carolina, 29405, United States

Location

Site 183

Memphis, Tennessee, 38119, United States

Location

Site 147

Fort Worth, Texas, 76104, United States

Location

Site 120

Houston, Texas, 77054, United States

Location

Site 172

Houston, Texas, 77081, United States

Location

Site 121

Draper, Utah, 84020, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Adam Savitz, MD, PhD

  Alto Neuroscience

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2022
• First Posted: February 3, 2023
• Study Start: January 10, 2023
• Primary Completion: September 5, 2024
• Study Completion: October 24, 2024
• Last Updated: September 8, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (34)