Andrew J. Cutler, MD

Efficacy and Safety of a Delayed-Release and Extended-Release Methylphenidate Formulation in Children With ADHD: Results From a Pivotal Phase 3 Trial in a Naturalistic Setting

Purpose: Evening-dosed HLD200 is a delayed-release and extended-release methylphenidate (DR/ER-MPH) designed to provide treatment effect in the early morning, throughout the day, and into...

Steven Pliszka , MD;

Jeffrey Newcorn , MD;

Samantha Bostrom , MD;

Frank López , MD;

Andrea Marraffino , PhD;

Norberto DeSousa , MA;

Bev Incledon , PhD;

F. Randy Sallee , MD, PhD;

Andrew J. Cutler , MD;

Valerie Arnold , MD;

Timothy Wilens , MD;

11/22/2019

Qelbree® (viloxazine extended-release capsules): Final Results of the Long-Term, Phase 3, Open-Label Extension Trial in Adults With Attention-Deficit/Hyperactivity Disorder

Final results of a long-term, open-label extension of a pivotal phase 3 study leading to FDA-approval of viloxazine extended-release capsules (Qelbree®) in adults.

Andrew J. Cutler , MD;

10/26/2023

Clinical Evaluation of Abuse Potential of Buprenorphine /Samidorphan (BUP/SAM) Combination

Introduction: Buprenorphine (BUP)/samidorphan (SAM) combination is an opioid system modulator being investigated as adjunctive treatment for major depressive disorder (MDD). The human abu...

Narinder Nangia , PhD;

Arielle Stanford , MD;

Andrew J. Cutler , MD;

Sanjeev Pathak , MD;

Sanjay Mathew , MD;

Michael E. DeBakey ;

Beatrice Setnik , PhD;

03/01/2019

Real-World Effectiveness of Deutetrabenazine When Initiated Using a 4-Week Patient Titration Kit: Interim Results of the START Study

START is an ongoing, noninterventional, prospective, single-arm, 2-cohort (tardive dyskinesia [TD] and Huntington disease) study evaluating the effectiveness of deutetrabenazine initiated...

Andrew J. Cutler , MD;

10/26/2023

Background: The impact of possible tardive dyskinesia (TD) was assessed in RE KINECT, a real-world study of antipsychotic-treated outpatients. Based on clinician assessments, patients wer...

William Lenderking , PhD;

Michael Serbin , PharmD;

Chuck Younan , PharmD;

Ericha Franey , PhD;

Andrew J. Cutler , MD;

Stanley Caroff , MD;

11/22/2019

Effects of Concomitant Medication Use on Tardive Dyskinesia Outcomes in Long-Term Valbenazine Trials

Background: Patients with tardive dyskinesia (TD) often take multiple concomitant medications for psychiatric comorbidities. Data from long-term valbenazine trials were analyzed to evalua...

Richard Josiassen , PhD;

Leslie Lundt , MD;

Andrew J. Cutler , MD;

Khodayar Farahmand , PharmD;

John Kane , MD;

Joshua Burke , MS;

Scott Siegert , PharmD;

03/01/2019

Tardive Dyskinesia Symptom Screening in Real-World Outpatient Settings: Correlations Between Patient-, Caregiver-, and Clinician-Reported Assessments in the RE-KINECT Study

Objective: To document possible tardive dyskinesia (TD) in psychiatric outpatients, as assessed by patients, caregivers, and clinicians.

Huda Shalhoub , PhD;

Jun Chen , MS, MSc;

Caroline Tanner , MD;

Karen Yeomans , BSc;

Ericha Anthony , MPH;

Chuck Yonan , PharmD;

Lydia John , MBBS, MD;

Andrew J. Cutler , MD;

Stanley Caroff , MD;

William Lenderking , PhD;

03/01/2019

Safety and Efficacy of Zuranolone 50 mg and Need for Repeat Treatment Courses in the Open-label, Phase 3 SHORELINE Study of Adult Patients With Major Depressive Disorder

Abstract: Introduction Zuranolone is a neuroactive steroid and positive allosteric modulator of both synaptic and extrasynaptic GABAA receptors in clinical development as an oral, once-da...

Andrew J. Cutler , MD;

Ryan Coleman ;

01/19/2023

Effect Size and NNT of the Dextroamphetamine Transdermal System (d-ATS) for ADHD in Children and Adolescents: Post-Hoc Analysis of a Pivotal Study

Abstract: Background: In a pivotal study, the dextroamphetamine transdermal system (d-ATS) met primary and secondary efficacy endpoints for ADHD in children and adolescents. This post-hoc...

Andrew J. Cutler , MD;

Peg Bader ;

01/19/2023

Somnolence and Sedation with Lumateperone Treatment: A Comparison of Morning and Evening Administration

Background: Somnolence and sedation are common treatment-emergent adverse events (TEAEs) reported with current antipsychotics. Lumateperone (lumateperone tosylate, ITI-007), a mechanistic...

Sharon Mates , PhD;

Andrew J. Cutler , MD;

William Rowe , MSN, RN, ACNP, BC;

Suresh Durgam , MD;

Robert Davis , PhD;

Andrew Satlin , MD;

Jason Huo , PhD;

10/08/2020