Leslie Citrome, MD

Assessing the Benefit-Risk Ratio of Approved Treatments for Bipolar Depression Using Likelihood to be Helped or Harmed (LHH) Analyses

Background: Four medications are FDA approved for acute bipolar depression: lurasidone (LUR), cariprazine (CAR), quetiapine IR & XR (QUE), and olanzapine-fluoxetine combination (OFC)....

Leslie Citrome , MD;

Robert Goldman , PhD;

Andrei Pikalov , MD, PhD;

Courtney Zeni , PhD;

10/08/2020

Assessing Treatment Patterns and Economic Impact of Atypical Antipsychotics as the First Adjunctive Treatment for MDD

Abstract: Introduction: Patients with major depressive disorder (MDD) often cycle through multiple treatments prior to receiving an adjunctive atypical antipsychotic (AA). This study eval...

Leslie Citrome , MD;

Mousam Parikh ;

01/19/2023

A Combination of Olanzapine and Samidorphan in Adults With Schizophrenia and Bipolar I Disorder: Overview of Clinical Data

Objectives: Olanzapine effectively treats schizophrenia and bipolar I disorder (BD-I); however, its use is hindered by significant weight gain. A combination of olanzapine and samidorphan...

Mark Todtenkopf , PhD;

Lauren DiPetrillo , PhD;

Hannah Cummings , PhD;

Leslie Citrome , MD;

Adam Simmons , MPH;

David McDonnell , MD;

Ying Jiang , PhD;

Lei Sun , PhD;

Christine Graham , PhD;

Bernard Silverman , MD;

10/08/2020

Full-Spectrum Efficacy of Cariprazine on Manic and Depressive Poles of Bipolar I Disorder in Patients Experiencing Manic or Depressive Episodes: Post Hoc Analysis of Randomized Controlled Trial Data

Abstract: Background: Treating patients with bipolar I disorder (BP-I) with an agent that is only effective against one pole may elicit treatment-emergent affective switch (TEAS), or wors...

Leslie Citrome , MD;

Huy-Binh Nguyen ;

01/19/2023

Effect of Dasotraline on Body Weight in Patients With Binge-Eating Disorder

Background: In a previous study, dasotraline, a long-acting dopamine/norepinephrine reuptake inhibitor, demonstrated significant efficacy in treatment of binge-eating disorder (BED). We n...

Leslie Citrome , MD;

Robert Goldman , PhD;

Ling Deng , PhD;

Todd Grinnell , BA;

Andrei Pikalov , MD, PhD;

Joyce Tsai , PhD;

11/22/2019

Early Improvement With Cariprazine as a Predictor of Antidepressant and Anxiolytic Response in Bipolar Depression: Pooled Post Hoc Analysis of 2 Randomized Cariprazine Trials

Abstract: Introduction: Treatment non-response may indicate need for further clinical management; thus, early prediction of treatment response can aid clinical decision-making, including ...

Leslie Citrome , MD;

Huy-Binh Nguyen ;

01/19/2023

Efficacy and Safety of an Asenapine Transdermal System (HP-3070) for Treatment of Adults with Schizophrenia: A Phase 3 Randomized, Placebo-Controlled, Inpatient Study

Background: HP-3070, an asenapine transdermal patch for schizophrenia, offers favorable pharmacokinetics with minimal peak and trough fluctuations.

David Walling , PhD, CNS, MD;

Courtney Zeni , PhD;

Marina Komaroff , DrPH;

Leslie Citrome , MD;

Alexandra Park , BSc;

11/22/2019

Efficacy of Adjunctive Cariprazine on Anxiety Symptoms in Patients With Major Depressive Disorder and Baseline Anxiety: Post Hoc Analysis of a Randomized Controlled Trial

Abstract: Background: Adjunctive cariprazine was evaluated in patients with major depressive disorder (MDD) and inadequate response to monotherapy antidepressant treatment (ADT), stratifi...

Vladimir Maletic , MD;

Leslie Citrome , MD;

01/19/2023

Efficacy (NNT) and Tolerability (NNH) of Cariprazine in Bipolar Disorder

Background: Cariprazine is approved to treat manic, mixed, and depressive symptoms of bipolar I disorder. This analysis describes the efficacy and tolerability of cariprazine in bipolar I...

Willie Earley , MD;

Mehul Patel , MD, PharmD;

Mauricio Tohen , MD, DrPH, MBA;

Leslie Citrome , MD;

11/22/2019

Positive and Negative Syndrome Scale Five-Factor Analysis Investigating the Efficacy of HP-3070 Transdermal System in Adults With Schizophrenia

Abstract: Background: HP-3070, a once-daily asenapine transdermal system, is FDA-approved for adults with schizophrenia. The Positive and Negative Syndrome Scale (PANSS) score’s five-fact...

Leslie Citrome , MD;

Peg Bader ;

01/19/2023