Bryan Dirks, MD, MSc, MBA

Exposure-Response Modeling From the CLARITY Trial of Pimavanserin for Adjunctive Treatment of Major Depressive Disorder

Pimavanserin, a selective serotonin inverse agonist/antagonist at the 5-HT2A/C receptors, is being actively studied for multiple indications. The CLARITY clinical trial program is evaluat...

Srdjan Stankovic , MD, MSPH;

Julie Passarell , MA;

Becky Howell , MA, MBA;

Joel Owen , PhD;

Mona Darwish , PhD;

Bryan Dirks , MD, MSc, MBA;

10/27/2020

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

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

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

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