Maggie Fedgchin, PharmD

Determining Meaningful Change in Depression Symptoms Assessed With the Patient Health Questionnaire (PHQ-9) and Sheehan Disability Scale (SDS) Among Patients With Treatment Resistant Depression in Trials of Esketamine Nasal Spray

Introduction: Meaningful change thresholds (MCT) derived from clinical outcome assessments quantify the change amount during pharmacologic treatment that is meaningful to the patient. We ...

Carol Jamieson , BSc;

Stacie Hudgens , MA, MSc;

Vanina Popova , MD;

Kimberly Cooper , MS;

Wayne Drevets , MD;

Maggie Fedgchin , PharmD;

Jaskaran Singh , MD;

Lysbeth Floden , PhD;

Rosanne Lane , MD, MSc, MS;

11/22/2019

Randomized, Double-Blind Study of Fixed-Dose Esketamine Nasal Spray Plus Oral Antidepressant vs. Active Control in Treatment-Resistant Depression

Aim: Compare efficacy and safety of fixed doses of esketamine nasal spray plus oral antidepressant (AD) to oral AD plus placebo nasal spray for treatment-resistant depression (TRD). Met...

Dawn Vitagliano , BA;

Michael Liebowitz , MD;

Arun Ravindran , MB, PhD, MSc;

Raphael Gaillard , MD, PhD;

Hans van den Ameele , MD;

Maurizio Fava , MD, PhD;

Ella Daly , MB, BCh, BAO;

Madhukar Trivedi , MD;

Wayne Drevets , MD;

Jaskaran Singh , MD;

Rosanne Lane , MD, MSc, MS;

Maggie Fedgchin , PharmD;