Back to resultsALTO-300 in Depression (ALTO-300-004)
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ALTO-300 PO Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
- Have a diagnosis of moderate to severe major depressive disorder
- Currently taking a SSRI, SNRI, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks
- Must have failed to adequately respond to the current antidepressant medication
- 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 liver impairment or disease
- Active suicidal ideation
- Moderate to severe Alcohol Use Disorder
- Diagnosed bipolar disorder or psychotic 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
Sites / Locations
- Cerebral - Atlanta
- Site 171
- Cerebral - New York City
- Cerebral - Dallas
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ALTO-300
Arm Description
ALTO-300 tablet PO; daily dosing 8 weeks
Outcomes
Primary Outcome Measures
To understand the relationship between baseline biology and change in the Montgomery-Asberg Depression Rating Scale (MADRS) with ALTO-300
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.
To understand the relationship between baseline biology and change in the Clinical Global Impression scale - Severity (CGI-S) with ALTO-300
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.
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability of ALTO-300
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Number of Participants With Clinically Significant Vital Signs Abnormalities as a Measure of Safety and Tolerability of ALTO-300
Vital signs measured include blood pressure, heart rate, respiratory rate, temperature, and weight.
Number of Participants With Clinically Significant Laboratory Abnormalities as a Measure of Safety and Tolerability of ALTO-300
Blood samples for serum chemistry and hematology will be collected for clinical laboratory testing.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05157945
Brief Title
ALTO-300 in Depression (ALTO-300-004)
Official Title
AN OPEN-LABEL STUDY OF ALTO-300 IN ADULTS WITH MAJOR DEPRESSIVE DISORDER
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 3, 2022 (Actual)
Primary Completion Date
April 26, 2023 (Actual)
Study Completion Date
May 5, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alto Neuroscience
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to collect biologically-based data for defining predictors and correlates of the effects of ALTO-300.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ALTO-300
Arm Type
Experimental
Arm Description
ALTO-300 tablet PO; daily dosing 8 weeks
Intervention Type
Drug
Intervention Name(s)
ALTO-300 PO Tablet
Intervention Description
One tablet daily
Primary Outcome Measure Information:
Title
To understand the relationship between baseline biology and change in the Montgomery-Asberg Depression Rating Scale (MADRS) with ALTO-300
Description
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.
Time Frame
Measured 6 times over 8 weeks
Title
To understand the relationship between baseline biology and change in the Clinical Global Impression scale - Severity (CGI-S) with ALTO-300
Description
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.
Time Frame
Measured 6 times over 8 weeks
Title
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability of ALTO-300
Description
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time Frame
From the signing of the ICF until the follow-up visit (up to 12 weeks)
Title
Number of Participants With Clinically Significant Vital Signs Abnormalities as a Measure of Safety and Tolerability of ALTO-300
Description
Vital signs measured include blood pressure, heart rate, respiratory rate, temperature, and weight.
Time Frame
From the signing of the ICF until the end-of-treatment visit (up to 11 weeks)]
Title
Number of Participants With Clinically Significant Laboratory Abnormalities as a Measure of Safety and Tolerability of ALTO-300
Description
Blood samples for serum chemistry and hematology will be collected for clinical laboratory testing.
Time Frame
From the signing of the ICF until the end-of-treatment visit (up to 11 weeks)]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a diagnosis of moderate to severe major depressive disorder
Currently taking a SSRI, SNRI, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks
Must have failed to adequately respond to the current antidepressant medication
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 liver impairment or disease
Active suicidal ideation
Moderate to severe Alcohol Use Disorder
Diagnosed bipolar disorder or psychotic 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
Facility Information:
Facility Name
Cerebral - Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30324
Country
United States
Facility Name
Site 171
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Cerebral - New York City
City
New York
State/Province
New York
ZIP/Postal Code
10013
Country
United States
Facility Name
Cerebral - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75212
Country
United States
12. IPD Sharing Statement
Learn more about this trial
ALTO-300 in Depression (ALTO-300-004)
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