A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder (AVENUE)
Principal Investigator: Cesar Soutullo, MD, PhD
Study Contact: Julia Bennett, Research Assistant I
Email Address: [email protected]
Phone number: 713-486-2890
This study is looking for referrals of patients who:
- Are between 12 and 17 years old
- English speaking
- In the physician’s opinion, acute psychiatric hospitalization is clinically warranted due to subject’s acute suicidality
- Must be medically stable based on physical examination
- No developmental or cognitive disability
Study Description:
AVENUE is a 25-week double-dummy, double-blind, randomized clinical trial designed for adolescents between the ages of 12 and 17 who are experiencing acute suicidality, warranting inpatient treatment. The study consists of inpatient treatment visits, outpatient treatment visits, and a longitudinal follow-up. Patient standard of care is not interfered with during the trial.
The purpose of this study is to evaluate the efficacy of intranasal esketamine in addition to comprehensive standard of care (SoC) in rapidly reducing the symptoms of major depressive disorder as compared with psychoactive placebo plus SoC in adolescent participants with acute suicidal ideation or behavior.
If you are a provider of patients who may qualify, please feel free to contact the study coordinator to refer a patient or learn more information.