Madhukar Trivedi, MD

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

Long-Term Treatment With Adjunctive Buprenorphine/Samidorphan Combination in Patients With Major Depressive Disorder: Interim Phase 3 Study Results

Introduction: Buprenorphine/samidorphan (BUP/SAM) is an investigational opioid system modulator demonstrating efficacy versus placebo as an adjunctive treatment for major depressive disor...

Sanjeev Pathak , MD;

Arielle Stanford , MD;

Maurizio Fava , MD, PhD;

Asli Memisoglu , ScD;

Madhukar Trivedi , MD;

William Martin , PhD;

Michael Thase , MD;

J. Alexander Bodkin , MD;

Amy Claxton , PhD;

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;

Pilar Lim , MD, PhD;

Patricio Molero , MD, PhD;

David Hough , MD;

Husseini Manji , MD;

Istvan Bitter , MD, PhD, DSc;

Adam Janik , MD;

Michael Thase , MD;

Honglan Li , MD, PhD;

Yun Zhang , PhD;

Anna Ducca , BSN;

Ella Daly , MB, BCh, BAO;

03/01/2019

A Buprenorphine-Samidorphan Combination (BUP/SAM) for Adjunctive Treatment of Major Depressive Disorder: Results From Analyses of US Patients From Three Placebo-Controlled Trials

Background: Buprenorphine/samidorphan (BUP/SAM) is an investigational opioid system modulator for adjunctive treatment of major depressive disorder. To account for differences in treatmen...

William Martin , PhD;

Elliot Ehrich , MD;

Michael Thase , MD;

Maurizio Fava , MD, PhD;

Madhukar Trivedi , MD;

Amy Claxton , PhD;

Sanjeev Pathak , MD;

Arielle Stanford , MD;

Asli Memisoglu , ScD;

02/28/2019

Effect of Adjunctive Pimavanserin on Insomnia and Function in Patients With Major Depressive Disorder: Secondary Analysis From CLARITY

Up to 90% of patients with major depressive disorder (MDD) experience sleep disturbances. CLARITY was a phase 2 study of adjunctive pimavanserin, a 5-hydroxytryptamine2A antagonist/invers...

Michael Thase , MD;

Richard Shelton , MD;

Keith Liu , PhD;

Susan Legacy , MD;

Bryan Dirks , MD, MSc, MBA;

Manish Jha ;

Maurizio Fava , MD, PhD;

Marlene Freeman , MD;

Madhukar Trivedi , MD;

George Papakostas , MD;

Srdjan Stankovic , MD, MSPH;

10/08/2020

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

Improvement of Sexual Function Observed During Treatment of Major Depressive Disorder With Adjunctive Pimavanserin

Sexual dysfunction occurs in 40%-60% of patients with major depressive disorder (MDD), due to either the illness itself and/or the effects of antidepressant treatment. The phase-2 CLARITY...

Srdjan Stankovic , MD, MSPH;

Michael Thase , MD;

Richard Shelton , MD;

Keith Liu , PhD;

Bryan Dirks , MD, MSc, MBA;

Manish Jha ;

Marlene Freeman , MD;

George Papakostas , MD;

Maurizio Fava , MD, PhD;

Madhukar Trivedi , MD;

11/22/2019

Impact of Treatment With Esketamine Nasal Spray in Patients With Treatment Resistant Depression and Comorbid Anxiety: A Post-hoc Pooled Analysis of the TRANSFORM 1 and 2 Trials

Purpose: To evaluate the impact of esketamine (ESK) nasal spray in patients with treatment-resistant depression (TRD) and comorbid anxiety.

Ibrahim Turkoz , PhD;

Ella Daly , MB, BCh, BAO;

Stephane Borentain , MD;

Madhukar Trivedi , MD;

Michael Thase , MD;

Jaskaran Singh , MD;

Giacomo Salvadore , MD;

Maggie Fedgchin , PharmD;

H. Lynn Starr , MD, FAAP;

A. John Rush , MD;

11/22/2019

CLARITY: A Phase 2 Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Major Depressive Disorder

This study examined pimavanserin (PIM), a 5-HT2A receptor inverse agonist/antagonist, as a potential adjunct to SSRIs or SNRIs for major depressive disorder (MDD). Adult female and male p...

Michael Thase , MD;

Richard Shelton , MD;

Keith Liu , PhD;

Susan Legacy , MD;

Bryan Dirks , MD, MSc, MBA;

Marlene Freeman , MD;

George Papakostas , MD;

Maurizio Fava , MD, PhD;

Madhukar Trivedi , MD;

Srdjan Stankovic , MD, MSPH;

11/22/2019