Wayne Drevets, MD

Withdrawal Symptom Assessment in an Esketamine Safety Study in Patients With Treatment-Resistant Depression in SUSTAIN-2 (NCT02497287)

We assessed potential withdrawal symptoms in patients with treatment-resistant depression (TRD) after long-term, intermittent use of intranasal esketamine (ESK). Patients received ESK 2X/...

Allitia DiBernardo , MD;

Ewa Wajs , MD, PhD;

Andrew Krystal , MD;

Lynn Yieh , PhD;

Ella Daly , MB, BCh, BAO;

Leah Aluisio , PhD;

Wayne Drevets , MD;

Yun Wu , PhD;

Jaskaran Singh , MD;

Peter Zannikos , PhD;

Jagadish Gogate , PhD;

Valerie Curran , PhD;

Guang Chen , MD, PhD;

11/22/2019

Assessment of Health-Related Quality of Life and Health Status in Patients With Treatment Resistant Depression Treated With Esketamine Nasal Spray Plus Oral Antidepressant Using European Quality of Life Group-5-Dimension-5-Level

Objective: To assess health-related quality of life (HRQoL) and health status of patients with treatment resistant depression (TRD), treated with esketamine nasal spray+oral antidepressan...

Vanina Popova , MD;

Ella Daly , MB, BCh, BAO;

Kimberly Cooper , MS;

Madhukar Trivedi , MD;

Wayne Drevets , MD;

Jaskaran Singh , MD;

11/22/2019

Esketamine Nasal Spray for Rapid Reduction of Major Depressive Disorder Symptoms in Adult Patients at Imminent Risk for Suicide: ASPIRE-1, a Phase 3 Randomized Study

Introduction: ASPIRE-1 is one of two global phase-3 studies in the registration program to evaluate efficacy and safety of esketamine nasal spray (ESK) vs placebo, with comprehensive stan...

Dong Jing Fu , MD, PhD;

Carla M. Canuso , MD;

Dawn F. Ionescu , MD;

Xiang Li , PhD;

Rosanne Lane , MD, MSc, MS;

Pilar Lim , MD, PhD;

David Hough , MD;

Husseini Manji , MD;

Wayne Drevets , MD;

11/22/2019

Esketamine Nasal Spray for Rapid Reduction of Major Depressive Disorder Symptoms in Adult Patients at Imminent Risk for Suicide: ASPIRE-2, a Phase 3 Randomized Study

Introduction: Efficacy and safety of esketamine (ESK) nasal spray were evaluated in ASPIRE-2 (NCT03097133), one of two phase-3 studies in the first global registration program in an under...

Dong Jing Fu , MD, PhD;

Carla M. Canuso , MD;

Dawn F. Ionescu , MD;

Rosanne Lane , MD, MSc, MS;

Pilar Lim , MD, PhD;

David Hough , MD;

Husseini Manji , MD;

Xin Qiu , MS;

Wayne Drevets , MD;

11/22/2019

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

Evaluation of Depression Severity Items on the Patient Health Questionnaire (PHQ-9) and Sheehan Disability Scale (SDS) in Patients With Treatment-Resistant Depression Treated With Esketamine Nasal Spray

Introduction: Major depressive disorder is a leading cause of disability and about 30% of patients are diagnosed with treatment-resistant depression (TRD) after failing two pharmacologica...

Lysbeth Floden , PhD;

Vanina Popova , MD;

Stacie Hudgens , MA, MSc;

Kimberly Cooper , MS;

Wayne Drevets , MD;

Jaskaran Singh , MD;

Carol Jamieson , BSc;

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;

Pilar Lim , MD, PhD;

Pierre Blier , MD, PhD;

David Hough , MD;

Rama Melkote , MSc, MPH;

Husseini Manji , MD;

03/01/2019

Esketamine Nasal Spray Combined With an Oral Antidepressant for Relapse Prevention in Treatment-Resistant Depression: Results of a Double-Blind, Randomized Withdrawal, Multicenter Study (SUSTAIN-1)

Background: Numerous studies have demonstrated short-term efficacy of esketamine in treatment-resistant depression (TRD), whereas long-term antidepressant effects remain to be established...

John Zajecka , MD;

Madhukar Trivedi , MD;

Andrew Winokur , MD, PhD;

Wayne Drevets , MD;

Ilona Divacka , MBA, MD;

Jaskaran Singh , MD;

Andrea Fagiolini , MD;

Wieslaw Cubala , MD, PhD;

Xiang Li , PhD;

Pierre Blier , MD, PhD;

Rosanne Lane , MD, MSc, MS;

Richard Shelton , MD;