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ALTO-100 in MDD and/or PTSD

Primary Purpose

Major Depressive Disorder, Post Traumatic Stress Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ALTO-100 PO tablet
Sponsored by
Alto Neuroscience
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have a diagnosis of moderate to severe major depressive disorder (MDD) and/or post-traumatic stress disorder (PTSD)
  • At baseline, either not taking an antidepressant medication, or currently taking a 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

Exclusion Criteria:

  • Evidence of unstable cardiovascular, respiratory, liver, or renal impairment or disease
  • Active suicidal ideation
  • 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

Sites / Locations

  • Site 136
  • Site 139
  • Site 141
  • Site 118
  • Site 116
  • Site 116
  • Site 150
  • Site 112
  • Site 155
  • Site 137
  • Site 151
  • Site 109
  • Site 108
  • Site 142
  • Site 144
  • Site 146
  • Site 147
  • Site 148
  • Site 120
  • Site 113
  • Site 121
  • Site 105
  • NTC Seattle (105a)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ALTO-100

Arm Description

ALTO-100 PO tablet, daily dosing 8 weeks

Outcomes

Primary Outcome Measures

To understand the relationship between baseline biology and clinical outcome with ALTO-100 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.
To understand the relationship between baseline biology and clinical outcome with ALTO-100 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.
To understand the relationship between baseline biology and clinical outcome with ALTO-100 using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) measures the severity of PTSD where smaller scores indicate less severe PTSD and higher scores suggest more severe PTSD. Possible scores for this 30 item version range from 0 to 120. 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-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 Vital Signs Abnormalities as a Measure of Safety and Tolerability of ALTO-100
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-100
Blood samples for serum chemistry and hematology will be collected for clinical laboratory testing.

Secondary Outcome Measures

Full Information

First Posted
November 2, 2021
Last Updated
December 20, 2022
Sponsor
Alto Neuroscience
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1. Study Identification

Unique Protocol Identification Number
NCT05117632
Brief Title
ALTO-100 in MDD and/or PTSD
Official Title
An Open-label Study of ALTO-100 in Adults With Major Depressive Disorder and/or Post-traumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 20, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
December 9, 2022 (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 goal 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, Post Traumatic Stress 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
245 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ALTO-100
Arm Type
Experimental
Arm Description
ALTO-100 PO tablet, daily dosing 8 weeks
Intervention Type
Drug
Intervention Name(s)
ALTO-100 PO tablet
Intervention Description
one tablet twice daily
Primary Outcome Measure Information:
Title
To understand the relationship between baseline biology and clinical outcome with ALTO-100 using the Montgomery-Åsberg Depression Rating Scale (MADRS)
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 5 times over 8 weeks
Title
To understand the relationship between baseline biology and clinical outcome with ALTO-100 using the Clinical Global Impression scale - Severity (CGI-S)
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 5 times over 8 weeks
Title
To understand the relationship between baseline biology and clinical outcome with ALTO-100 using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Description
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) measures the severity of PTSD where smaller scores indicate less severe PTSD and higher scores suggest more severe PTSD. Possible scores for this 30 item version range from 0 to 120. The change from baseline to the end of the study is the primary outcome.
Time Frame
Measured 3 times over 8 weeks
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 12 weeks)
Title
Number of Participants With Clinically Significant Vital Signs Abnormalities as a Measure of Safety and Tolerability of ALTO-100
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-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 11 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have a diagnosis of moderate to severe major depressive disorder (MDD) and/or post-traumatic stress disorder (PTSD) At baseline, either not taking an antidepressant medication, or currently taking a 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 Exclusion Criteria: Evidence of unstable cardiovascular, respiratory, liver, or renal impairment or disease Active suicidal ideation 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
Facility Information:
Facility Name
Site 136
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States
Facility Name
Site 139
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Site 141
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Site 118
City
Fresno
State/Province
California
ZIP/Postal Code
93703
Country
United States
Facility Name
Site 116
City
Martinez
State/Province
California
ZIP/Postal Code
94553
Country
United States
Facility Name
Site 116
City
Mather
State/Province
California
ZIP/Postal Code
95655
Country
United States
Facility Name
Site 150
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
Facility Name
Site 112
City
Doral
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
Site 155
City
Elgin
State/Province
Illinois
ZIP/Postal Code
60123
Country
United States
Facility Name
Site 137
City
Noblesville
State/Province
Indiana
ZIP/Postal Code
46060
Country
United States
Facility Name
Site 151
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Site 109
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
Facility Name
Site 108
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Site 142
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Site 144
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Site 146
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Site 147
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Site 148
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76244
Country
United States
Facility Name
Site 120
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Site 113
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Site 121
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
Site 105
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
NTC Seattle (105a)
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

ALTO-100 in MDD and/or PTSD

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