Maurizio Fava, MD, PhD

Depression in Parkinson`s Disease: Investigations of Pimavanserin, a Selective 5-HT2A Receptor Antagonist/Inverse Agonist

Depression occurs in 30–50% of Parkinson’s disease (PD) patients, yet no drugs are approved specifically to treat PD patients with depressive symptoms. Few clinical studies have been cond...

Rene Nunez , MD;

Maurizio Fava , MD, PhD;

Daryl DeKarske , MPH;

Lori Jacobi , BA;

Bruce Coate , MPH;

Keith Liu , PhD;

Susan Legacy , MD;

Bryan Dirks , MD, MSc, MBA;

10/08/2020

An Assessment of the Impact of Prior Antipsychotic Treatment on the Duration of Treatment with RBP-7000 during a Long-Term Safety Study

Introduction: RBP-7000 (PERSERIS™) is a once-monthly subcutaneous extended-release risperidone formulation approved for the treatment of schizophrenia in adults, designed to deliver clini...

Anne Andorn , MD;

James Graham , PharmD, BS Pharm, RPh;

Maurizio Fava , MD, PhD;

John Csernansky , MD;

John Newcomer , MD;

Anne Le Moigne , PhD;

10/08/2020

ADVANCE: Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Adjunctive Pimavanserin in Patients With Negative Symptoms of Schizophrenia

Pimavanserin is a selective, 5-hydroxytryptamine (5-HT)2A receptor inverse agonist/antagonist with lower activity at 5-HT2C receptors. Previous studies have shown beneficial effects of ad...

Dragana Bugarski-Kirola , MD, MBA, MSc;

Srdjan Stankovic , MD, MSPH;

Celso Arango , MD, PhD;

Henry Nasrallah , MD;

I-Yuan Liu , MSc;

Brandon Abbs , PhD;

Maurizio Fava , MD, PhD;

10/08/2020

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

Efficacy of Monthly Extended-release Risperidone Injections (RBP-7000) for the Treatment of Schizophrenia: An Analysis of Individual PANSS Items

Introduction: RBP-7000 (PERSERIS™) is a once-monthly, subcutaneous, extended-release risperidone formulation that is approved for treating schizophrenia in adults and is designed to deliv...

Anne Andorn , MD;

James Graham , PharmD, BS Pharm, RPh;

Maurizio Fava , MD, PhD;

John Csernansky , MD;

John Newcomer , MD;

Sunita Shinde , MD;

Gilbert Muma , PhD;

Christian Heidbreder , PhD;

David Walling , PhD, CNS, 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

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

RBP-7000 for the Treatment of Schizophrenia: Efficacy and Safety Results From Two Phase III Trials

Introduction: RBP-7000 is a subcutaneously administered, once-monthly, extended-release depot formulation of risperidone designed to achieve therapeutic concentrations without supplementa...

Anne Andorn , MD;

Maurizio Fava , MD, PhD;

John Newcomer , MD;

Sunita Shinde , MD;

Gilbert Muma , PhD;

Christian Heidbreder , PhD;

Jay Graham , BS Pharm, PharmD, RPh;

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