Back to resultsPilot Decentralized Trial
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ALTO-100 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
- Either currently taking a SSRI, SNRI, mirtazapine, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks, or are not taking an antidepressant medication
- Willing to comply with all study assessments and procedures
- Must not be pregnant or breastfeeding at time of enrollment or throughout study
- Must have access with privacy to a computer with a keyboard and internet
Exclusion Criteria:
- Evidence of acute or unstable cardiovascular, respiratory, hepatic, or other major disease
- Active suicidal ideation
- Severe impediment to vision, hearing, and/or hand movement
- Diagnosed bipolar disorder or psychotic 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
Sites / Locations
- Site 160
- Site 156
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ALTO-100
Arm Description
ALTO-100 tablet PO ; twice daily dosing 8 weeks
Outcomes
Primary Outcome Measures
To understand the relationship between baseline biology and score change in the Montgomery-Asberg Depression Rating Scale (MADRS) with ALTO-100 from start of dosing to end of treatment
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 score change from the start of dosing (Day 1) to the end of treatment (Day 56) is the primary outcome.
To understand the relationship between baseline biology and score change in the Clinical Global Impression scale - Severity (CGI-S) with ALTO-100 from Screening to end of treatment
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 score change from Screening (Day [-21]) to the end of treatment (Day 56) is the primary outcome.
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability of ALTO-100
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 Laboratory Abnormalities as a Measure of Safety and Tolerability of ALTO-100
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
NCT05419869
Brief Title
Pilot Decentralized Trial
Official Title
An Open-Label Study of ALTO-100 in Adults With Major Depressive Disorder (MDD)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
January 13, 2023 (Actual)
Study Completion Date
January 26, 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-100.
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
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ALTO-100
Arm Type
Experimental
Arm Description
ALTO-100 tablet PO ; twice daily dosing 8 weeks
Intervention Type
Drug
Intervention Name(s)
ALTO-100 PO Tablet
Intervention Description
Two tablets daily
Primary Outcome Measure Information:
Title
To understand the relationship between baseline biology and score change in the Montgomery-Asberg Depression Rating Scale (MADRS) with ALTO-100 from start of dosing to end of treatment
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 score change from the start of dosing (Day 1) to the end of treatment (Day 56) is the primary outcome.
Time Frame
Measured at Day 1, Day 14, Day 28, Day 42, Day 56
Title
To understand the relationship between baseline biology and score change in the Clinical Global Impression scale - Severity (CGI-S) with ALTO-100 from Screening to end of treatment
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 score change from Screening (Day [-21]) to the end of treatment (Day 56) is the primary outcome.
Time Frame
Measured at Screening, Day 1, Day 14, Day 28, Day 42, Day 56
Title
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability of ALTO-100
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 13 weeks)
Title
Number of Participants With Clinically Significant Laboratory Abnormalities as a Measure of Safety and Tolerability of ALTO-100
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 13 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a diagnosis of moderate to severe major depressive disorder
Either currently taking a SSRI, SNRI, mirtazapine, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks, or are not taking an antidepressant medication
Willing to comply with all study assessments and procedures
Must not be pregnant or breastfeeding at time of enrollment or throughout study
Must have access with privacy to a computer with a keyboard and internet
Exclusion Criteria:
Evidence of acute or unstable cardiovascular, respiratory, hepatic, or other major disease
Active suicidal ideation
Severe impediment to vision, hearing, and/or hand movement
Diagnosed bipolar disorder or psychotic 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
Facility Information:
Facility Name
Site 160
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Site 156
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.researchforrelief.com
Description
Alto Neuroscience Mental Health Research Registry
Learn more about this trial
Pilot Decentralized Trial
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