Study of ALTO-300 in MDD

A Randomized, Double-Blind, Placebo-Controlled Study of ALTO-300 With an Open-Label Extension in Adults With Major Depressive Disorder

The purpose of this study is to determine efficacy differences between ALTO-300 and placebo, used adjunctively to an antidepressant, related to patient characteristics.

Study Overview

• Status: Recruiting
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: ALTO-300; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Alto Neuroscience; Phone Number: 650-200-0412; Email: clinical@altoneuroscience.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Recruiting
      • Site 200
    • Phoenix, Arizona, United States, 85021
      • Active, not recruiting
      • Site 189
    • Yuma, Arizona, United States, 85364
      • Recruiting
      • Site 187
  • Arkansas
    • Rogers, Arkansas, United States, 72758
      • Recruiting
      • Site 193
  • California
    • Bellflower, California, United States, 90706
      • Recruiting
      • Site 218
    • Glendale, California, United States, 91206
      • Recruiting
      • Site 217
    • Los Angeles, California, United States, 90064
      • Recruiting
      • Site 209
    • Mather, California, United States, 95655
      • Not yet recruiting
      • Site 219
    • Mission Viejo, California, United States, 92691
      • Recruiting
      • Site 194
    • Temecula, California, United States, 92591
      • Recruiting
      • Site 197
  • Colorado
    • Colorado Springs, Colorado, United States, 80918
      • Recruiting
      • Site 203
  • Connecticut
    • Norwalk, Connecticut, United States, 06851
      • Recruiting
      • Site 214
  • Florida
    • Clermont, Florida, United States, 34711
      • Recruiting
      • Site 159
    • Miami Lakes, Florida, United States, 33016
      • Recruiting
      • Site 190
    • Okeechobee, Florida, United States, 34972
      • Recruiting
      • Site 161
    • Tampa, Florida, United States, 33629
      • Not yet recruiting
      • Site 221
    • West Palm Beach, Florida, United States, 33407
      • Recruiting
      • Site 220
  • Georgia
    • Snellville, Georgia, United States, 30078
      • Recruiting
      • Site 208
  • Idaho
    • Boise, Idaho, United States, 83702
      • Recruiting
      • Site 119
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Recruiting
      • Site 201
    • Monroe, Louisiana, United States, 71201
      • Recruiting
      • Site 198
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Recruiting
      • Site 215
  • New Mexico
    • Albuquerque, New Mexico, United States, 87108
      • Recruiting
      • Site 114
  • New York
    • Rochester, New York, United States, 14618
      • Recruiting
      • Site 191
    • Staten Island, New York, United States, 10314
      • Recruiting
      • Site 192
  • North Carolina
    • Hickory, North Carolina, United States, 28601
      • Recruiting
      • Site 199
  • Ohio
    • Cincinnati, Ohio, United States, 45215
      • Recruiting
      • Site 202
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Recruiting
      • Site 195
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Recruiting
      • Site 216
  • Texas
    • Dallas, Texas, United States, 75235
      • Recruiting
      • Site 102
    • Fort Worth, Texas, United States, 76244
      • Active, not recruiting
      • Site 148
    • Missouri City, Texas, United States, 77459
      • Recruiting
      • Site 206
    • Richmond, Texas, United States, 77407
      • Recruiting
      • Site 196
  • Utah
    • Clinton, Utah, United States, 84015
      • Recruiting
      • Site 207
  • Virginia
    • Roanoke, Virginia, United States, 24018
      • Recruiting
      • Site 211

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Have a diagnosis of moderate to severe major depressive disorder (MDD)
• At Visit 2, currently taking a single SSRI, SNRI, 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

Exclusion Criteria:

• Evidence of unstable medical condition
• Nightly use of sleep medication
• Diagnosed bipolar disorder, psychotic disorder, or dementia
• Current moderate or severe substance use 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ALTO-300; Participants will receive ALTO-300 capsule once daily in the evening, 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-300 capsule once daily in the evening from OL baseline until the end of OL period/early termination visit (Up to 8 weeks).	Drug: ALTO-300; ALTO-300 capsule QD
Placebo Comparator: Placebo; Participants will receive matching placebo capsule once daily in the evening, from Day 1 to Day 42 in double blind (DB) treatment period.	Drug: Placebo; Placebo capsule QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess efficacy of adjunctive ALTO-300 versus placebo on symptoms of MDD in a pre-defined subgroup of participants as measured by the change over time up to week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS).	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 over time for up to week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess efficacy of adjunctive ALTO-300 versus placebo on symptoms of MDD in all randomized participants as measured by the change over time up to week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS)	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 over time for up to week 6
To assess efficacy of adjunctive ALTO-300 versus placebo for MDD as measured by the change over time up to week 6 in response (>50% improvement from baseline) rates based on the MADRS	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 over time for up to week 6
To evaluate the safety of ALTO-300 during both the OL and DB periods of the study as measured by the assessment of the incidence, severity, and relatedness of Adverse Events.	Incidence, severity, and relatedness of Adverse Events	Assessed from Day 1 to Week 14
To evaluate the safety of ALTO-300 during both the OL and DB periods of the study as measured by the assessment of Heart Rate.	Assessment of Heart Rate	Assessed from Day 1 to Week 14
To evaluate the safety of ALTO-300 during both the OL and DB periods of the study as measured by the assessment of Weight.	Assessment of Weight	Assessed from Day 1 to Week 14
To evaluate the safety of ALTO-300 during both the OL and DB periods of the study as measured by the assessment of Blood Pressure.	Assessment of Blood Pressure	Assessed from Day 1 to Week 14
To evaluate the safety of ALTO-300 during both the OL and DB periods of the study as measured by the assessment of suicidality with the Concise Health Risk Tracking Self-Report,12 item scale (CHRT-SR12).	The CHRT is a brief, self-report measure that systematically assesses both suicidal thinking and associated thoughts that may indicate the propensity for suicidal acts. The CHRT-SR12 is a 12 item scale. The patient assigns a score of 0-4 for each item of the scale, allowing for a total score of 0 to 48, with the higher score signifying more severe symptoms.	Assessed from Day 1 to Week 15

Collaborators and Investigators

• Sponsor: Alto Neuroscience
• Investigators: Study Director: Adam Savitz, MD, PhD, Alto Neuroscience

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: May 26, 2023
• First Submitted That Met QC Criteria: June 19, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: ALTO-300-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No