ALTO-100 in Major Depressive Disorder

Sponsor
Alto Neuroscience (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05419869
Collaborator
(none)
225
1
1
11
20.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: ALTO-100 PO Tablet
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
225 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 (MDD)
Actual Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: ALTO-100

ALTO-100 tablet PO ; twice daily dosing 8 weeks

Drug: ALTO-100 PO Tablet
Two tablets daily

Outcome Measures

Primary Outcome Measures

  1. 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 [Measured at Day 1, Day 14, Day 28, Day 42, Day 56]

    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.

  2. 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 [Measured at Screening, Day 1, Day 14, Day 28, Day 42, Day 56]

    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.

  3. Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability of ALTO-100 [From the signing of the ICF until the follow-up visit (up to 13 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.

  4. Number of Participants With Clinically Significant Laboratory Abnormalities as a Measure of Safety and Tolerability of ALTO-100 [From the signing of the ICF until the end-of-treatment visit (up to 13 weeks)]

    Blood samples for serum chemistry and hematology will be collected for clinical laboratory testing.

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Site 156 Jackson Mississippi United States 39216

Sponsors and Collaborators

  • Alto Neuroscience

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Alto Neuroscience
ClinicalTrials.gov Identifier:
NCT05419869
Other Study ID Numbers:
  • ALTO-100-003
First Posted:
Jun 15, 2022
Last Update Posted:
Jun 15, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 15, 2022