ALTO-300 in Depression

Sponsor
Alto Neuroscience (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05118750
Collaborator
(none)
200
1
1
17.6
11.4

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-300.

Condition or Disease Intervention/Treatment Phase
  • Drug: ALTO-300 PO tablet
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label Study of ALTO-300 in Adults With Major Depressive Disorder
Actual Study Start Date :
Dec 13, 2021
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: ALTO-300

ALTO-300 tablet PO; daily dosing 8 weeks

Drug: ALTO-300 PO tablet
One tablet daily

Outcome Measures

Primary Outcome Measures

  1. To understand the relationship between baseline biology and clinical outcome with ALTO-300 using the Montgomery-Åsberg Depression Rating Scale (MADRS) [Measured 6 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-300 using the Clinical Global Impression scale - Severity (CGI-S) [Measured 6 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. Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability of ALTO-300 [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.

  4. Number of Participants With Clinically Significant Vital Signs Abnormalities as a Measure of Safety and Tolerability of ALTO-300 [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.

  5. Number of Participants With Clinically Significant Laboratory Abnormalities as a Measure of Safety and Tolerability of ALTO-300 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 74 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Site 102 Dallas Texas United States 75235

Sponsors and Collaborators

  • Alto Neuroscience

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alto Neuroscience
ClinicalTrials.gov Identifier:
NCT05118750
Other Study ID Numbers:
  • ALTO-300-002
First Posted:
Nov 12, 2021
Last Update Posted:
Jan 5, 2022
Last Verified:
Jan 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 Jan 5, 2022