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ALTO-100 in MDD and/or PTSD

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ClinicalTrials.gov Identifier: NCT05117632
Recruitment Status : Not yet recruiting
First Posted : November 11, 2021
Last Update Posted : November 25, 2021
Sponsor:
Information provided by (Responsible Party):
Alto Neuroscience

Brief Summary:
The goal of this study is to collect biologically based data for defining predictors and correlates of the effects of ALTO-100.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Post Traumatic Stress Disorder Drug: ALTO-100 PO tablet Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study of ALTO-100 in Adults With Major Depressive Disorder and/or Post-traumatic Stress Disorder
Estimated Study Start Date : November 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ALTO-100
ALTO-100 PO tablet, daily dosing 8 weeks
Drug: ALTO-100 PO tablet
one tablet twice daily




Primary Outcome Measures :
  1. To understand the relationship between baseline biology and clinical outcome with ALTO-100 using the Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Measured 5 times over 8 weeks ]
    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.

  2. To understand the relationship between baseline biology and clinical outcome with ALTO-100 using the Clinical Global Impression scale - Severity (CGI-S) [ Time Frame: Measured 5 times over 8 weeks ]
    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.

  3. To understand the relationship between baseline biology and clinical outcome with ALTO-100 using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) [ Time Frame: Measured 3 times over 8 weeks ]
    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.

  4. Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability of ALTO-100 [ Time Frame: From the signing of the ICF until the follow-up visit (up to 12 weeks) ]
    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.

  5. Number of Participants With Clinically Significant Vital Signs Abnormalities as a Measure of Safety and Tolerability of ALTO-100 [ Time Frame: From the signing of the ICF until the end-of-treatment visit (up to 11 weeks) ]
    Vital signs measured include blood pressure, heart rate, respiratory rate, temperature, and weight.

  6. Number of Participants With Clinically Significant Laboratory Abnormalities as a Measure of Safety and Tolerability of ALTO-100 [ Time Frame: From the signing of the ICF until the end-of-treatment visit (up to 11 weeks) ]
    Blood samples for serum chemistry and hematology will be collected for clinical laboratory testing.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05117632


Contacts
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Contact: Jillian Autea 650-397-5693 jillianautea@altoneuroscience.com
Contact: Lesley Parker lparker@altoneuroscience.com

Sponsors and Collaborators
Alto Neuroscience
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Responsible Party: Alto Neuroscience
ClinicalTrials.gov Identifier: NCT05117632    
Other Study ID Numbers: ALTO-100-001
First Posted: November 11, 2021    Key Record Dates
Last Update Posted: November 25, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Trauma and Stressor Related Disorders