ALTO-207 in Adults With Treatment-resistant Depression (TRD)

Purpose

The purpose of this trial is to measure depressive symptoms following treatment with ALTO-207 compared with placebo in participants with TRD.

Condition

  • Treatment-resistant Depression (TRD)

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Male and female participants, ages 18 to 75 years, inclusive, at the time of signing the ICF. - Prior diagnosis of MDD without psychotic symptoms (in the current episode) and have confirmatory diagnosis of current MDD (moderate to severe). - Failure to respond (<50% improvement) to at least 2-5 antidepressant treatments (including the current treatment) - Currently taking a stable dose of at least 1 but no more than 2 oral antidepressants at baseline

Exclusion Criteria

  • Evidence of unstable medical condition - Concurrent use of any prohibited medications or substance use disorder - Diagnosed bipolar disorder or a psychotic disorder or symptoms - Significant current PTSD symptoms or history of PTSD - Clinically significant current impulse control difficulties - Has a history of hypersensitivity or allergic reaction to ALTO-207 or any of its components/excipients - Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ALTO-207
  • Drug: ALTO-207
    ALTO-207 BID
Placebo Comparator
Placebo
  • Drug: Placebo
    Matching Placebo

Recruiting Locations

Site 7000
Phoenix, Arizona 85012

Site 7082
Oceanside, California 92056

Site 7144
San Diego, California 92123

Site 7152
Saint Augustine, Florida 32086

Site 7148
Albany, Georgia 31707

Site 7141
Savannah, Georgia 31406

Site 7151
Annapolis, Maryland 21401

Site 7154
Bloomfield Hills, Michigan 48302

Site 7143
Charlotte, North Carolina 28287

Site 7029
Cincinnati, Ohio 45215

Site 7145
Houston, Texas 77030

Site 7161
Irving, Texas 75062

More Details

NCT ID
NCT07553637
Status
Recruiting
Sponsor
Alto Neuroscience

Study Contact

Alto Neuroscience
650-200-0412
clinical@altoneuroscience.com

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center