RECRUITING

Study of ALTO-300 in MDD

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Conditions

Major Depressive Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to determine efficacy differences between ALTO-300 and placebo, used adjunctively to an antidepressant, related to patient characteristics.

Official Title

A Randomized, Double-Blind, Placebo-Controlled Study of ALTO-300 With an Open-Label Extension in Adults With Major Depressive Disorder

Quick Facts

Study Start:2023-06-08
Study Completion:2025-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05922878

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have a diagnosis of moderate to severe major depressive disorder (MDD)
  2. * At Visit 2, currently taking a single SSRI, SNRI, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks
  3. * Willing to comply with all study assessments and procedures
  4. * Must not be pregnant or breastfeeding at time of enrollment or throughout study
  1. * Evidence of unstable medical condition
  2. * Nightly use of sleep medication
  3. * Diagnosed bipolar disorder, psychotic disorder, or dementia
  4. * Current moderate or severe substance use disorder
  5. * Has a history of hypersensitivity or allergic reaction to ALTO-300 or any of its components/excipients
  6. * Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device

Contacts and Locations

Study Contact

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

Principal Investigator

Adam Savitz, MD, PhD
STUDY_DIRECTOR
Alto Neuroscience

Study Locations (Sites)

Site 200
Phoenix, Arizona, 85012
United States
Site 189
Phoenix, Arizona, 85021
United States
Site 187
Yuma, Arizona, 85364
United States
Site 193
Rogers, Arkansas, 72758
United States
Site 218
Bellflower, California, 90706
United States
Site 217
Glendale, California, 91206
United States
Site 335
Lafayette, California, 94549
United States
Site 209
Los Angeles, California, 90064
United States
Site 219
Mather, California, 95655
United States
Site 194
Mission Viejo, California, 92691
United States
Site 197
Temecula, California, 92591
United States
Site 203
Colorado Springs, Colorado, 80918
United States
Site 349
Evergreen, Colorado, 80439
United States
Site 214
Norwalk, Connecticut, 06851
United States
Site 159
Clermont, Florida, 34711
United States
Site 225
Miami Gardens, Florida, 33014
United States
Site 190
Miami Lakes, Florida, 33016
United States
Site 161
Okeechobee, Florida, 34972
United States
Site 221
Tampa, Florida, 33629
United States
Site 220
West Palm Beach, Florida, 33407
United States
Site 224
Savannah, Georgia, 31405
United States
Site 208
Snellville, Georgia, 30078
United States
Site 119
Boise, Idaho, 83702
United States
Site 201
Marrero, Louisiana, 70072
United States
Site 198
Monroe, Louisiana, 71201
United States
Site 215
Jackson, Mississippi, 39216
United States
Site 344
Las Vegas, Nevada, 89102
United States
Site 114
Albuquerque, New Mexico, 87108
United States
Site 191
Rochester, New York, 14618
United States
Site 192
Staten Island, New York, 10314
United States
Site 199
Hickory, North Carolina, 28601
United States
Site 202
Cincinnati, Ohio, 45215
United States
Site 195
Oklahoma City, Oklahoma, 73112
United States
Site 216
Allentown, Pennsylvania, 18104
United States
Site 350
Media, Pennsylvania, 19063
United States
Site 352
Moosic, Pennsylvania, 18507
United States
Site 102
Dallas, Texas, 75235
United States
Site 347
Fort Worth, Texas, 76104
United States
Site 148
Fort Worth, Texas, 76244
United States
Site 206
Missouri City, Texas, 77459
United States
Site 353
Plano, Texas, 75093
United States
Site 196
Richmond, Texas, 77407
United States
Site 207
Clinton, Utah, 84015
United States
Site 211
Roanoke, Virginia, 24018
United States

Collaborators and Investigators

Sponsor: Alto Neuroscience

  • Adam Savitz, MD, PhD, STUDY_DIRECTOR, Alto Neuroscience

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-08
Study Completion Date2025-05

Study Record Updates

Study Start Date2023-06-08
Study Completion Date2025-05

Terms related to this study

Additional Relevant MeSH Terms

  • Major Depressive Disorder