CURRICULUM VITAE CONTACT INFORMATION: Site Selection and Information: Bobbie Theodore, Site Liaison Tel. (916) 939-6696 Fax (208) 575-3169 Email: clinicaltrials@alliancesites.com AFFILIATIONS: Andrew J. Cutler, M.D. Florida Clinical Research Center, LLC. 8043 Cooper Creek Blvd., Suite 107 Bradenton, FL 34201 Tel. (941)-747-7900 acutler@flcrc.com Manatee Glens Hospital Aspire Health Partners 2020 26 th Avenue East 434 West Kennedy Blvd. Bradenton, FL 34208 Orlando, FL 32810 Aspire Health Partners 100 West Columbia Street Orlando, FL 32806 EDUCATION: 1983 Bachelor of Science in Biology Haverford College, Philadelphia, Pennsylvania 1989 Doctor of Medicine University of Virginia, School of Medicine, Charlottesville, Virginia RESIDENCIES: 1989-1993 Residency in Internal Medicine University of Virginia, Health Sciences Center, Charlottesville, Virginia 1990-1994 Residency in Psychiatry University of Virginia, Health Sciences Center, Charlottesville, Virginia Updated 9/9/2015 1
CERTIFICATION: Certified Principal Investigator (CPI), Association of Clinical Research Professionals (ACRP) 2005 American Board of Psychiatry and Neurology, October 1995 American Board of Internal Medicine, December 1993 LICENSURE: Florida Medical License: July 1995, No. ME 0068720 Drug Enforcement Agency License: Number available on request PROFESSIONAL EXPERIENCE: Medical Director, President, and Principal Investigator, 1998 - Present Florida Clinical Research Center LLC, Central Florida Courtesy Assistant Professor, Department of Psychiatry, 2007 - Present University of Florida, Gainesville, FL Clinical Assistant Professor, Department of Psychiatry and Behavioral Medicine, 1999 - Present University of South Florida, Tampa, Florida Instructor, Department of Psychology, 1999 - Present University of Central Florida, Orlando, Florida Medical Director/Director of Psychopharmacology Research, 1998-2002 Lakeside Alternatives Behavioral Healthcare Systems, Orlando, Florida Co-Medical Director/Co-Director of Psychopharmacology Research, 1996-1998 Psychiatric Institute of Florida, Orlando, Florida Director of Psychiatric Medicine and Psychiatry Grand Rounds, 1995-1996 Florida Hospital South, Orlando, Florida Director of Consultation-Liaison Psychiatry, Department of Psychiatry, 1994-1995 University of Chicago, Biologic Sciences Division, Chicago, Illinois Director of Adult Inpatient Services, Department of Psychiatry, 1994-1995 University of Chicago, Biologic Sciences Division, Chicago, Illinois Director of Psychiatric Medicine, Department of Psychiatry, 1994-1995 University of Chicago, Biologic Sciences Division, Chicago, Illinois Assistant Professor, Department of Psychiatry, 1994-1995 University of Chicago, Biologic Sciences Division, Chicago, Illinois Updated 9/9/15 2
INVESTIGATOR EXPERIENCE: Attention Deficit Hyperactivity Disorder (ADHD) Alzheimer s Disease Anxiety Disorders including Panic Bipolar Disorder Cognition Depression Fibromyalgia Influenza Schizophrenia Smoking Cessation Sleep Disorders Substance Abuse and Other Addictions ADDITIONAL TREATMENT EXPERIENCE: Migraine Obesity Pain Pediatric Disorders Post Traumatic Stress Disorder (PTSD) Sexual Dysfunction CLINICAL TRIAL EXPERIENCE: Addiction The Phase III, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of XXX in Adults Aged 18-55 Years with Moderate to Severe Binge Eating Disorder A Phase III, Multicenter, Open-label, 12-month Extension Safety and Tolerability Study of XXX in the Treatment of Adults with Binge Eating Disorder A Phase II, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Forceddose Titration Study to Evaluate the Efficacy, Safety, and Tolerability of XXX in Adults Aged 18-55 Years with Binge Eating Disorder A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Adaptive Study of the Safety and Efficacy of XXX in Adults with Alcohol Dependence ADHD A Phase IIb, Randomized, Double-Blind, Multicenter, Placebo-Controlled, Crossover, Safety and Efficacy Study of XXX in Adults With Attention-Deficit Hyperactivity Disorder (ADHD) A Phase IIB, Interventional, randomised, double-blind, placebo-controlled, fixed-dose study of XXX in adults with Attention Deficit Hyperactivity Disorder (ADHD) A Phase III, Randomized, Double-blind, Multi-center, Placebo-controlled, Dose-Optimization, Safety and Efficacy Study of XXX in Children and Adolescents Aged 6-17 Years with Attention-Deficit Hyperactivity Disorder (ADHD) Updated 9/9/2015 3
A Phase I, Investigational Study to Evaluate Usability of ADHD patch in a Naturalistic Setting and to assess Adhesion of ADHD patch compared to XXX in the Clinic Setting in Children, Adolescents and Adults with ADHD A Phase III, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Evening-dosed XXX, a Novel Delayed and Extended Release Formulation of XXX, on Post-waking, Early Morning Function in Children Aged 6 to 12 With Attention Deficit Hyperactivity Disorder (ADHD) A Phase III, Multicenter, Open-label Treatment-optimized, Double-blind, Randomized, Placebocontrolled, Forced-withdrawal, Parallel Group Study to Evaluate the Safety and Efficacy of Evening Dosed XXX, a Novel Delayed and Extended Release Formulation of XXX, in Children Aged 6-12 with Attention Deficit Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting An Investigational Study to Evaluate Usability of ADHD patch in a Naturalistic Setting and to assess Adhesion of ADHD patch compared to XXX in the Clinic Setting in Children, Adolescents and Adults with ADHD Study to conduct psychometric tests on the electronic observer-reported (eobsro) Aggression Diary to evaluate whether the diary is a valid and reliable measure for assessing the benefit of XXX extended-release tablets) for the treatment of Impulse Aggression A Phase III, 12-Month, Multicenter, Open-label, Safety Study of XXX in Adults with Attention Deficit Hyperactivity Disorder (ADHD) Study to conduct psychometric tests on the electronic observer-reported (eobsro) Aggression Diary to evaluate whether the diary is a valid and reliable measure for assessing the benefit of XXX extended-release tablets) for the treatment of Impulse Aggression A Six-Month Open-Label, Multi-Center Study of the Safety and Efficacy of XXX in Adults and Adolescents with ADHD A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Multi-Center Study Measuring the Efficacy and Safety of XXX in Adolescent ADHD Patients A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Multi-Center Study Measuring the Efficacy and Safety of XXX in Adult ADHD Patients An Open Label Study to Assess the Feasibility of XXX, Game-play, to Engage Subjects with Attention Deficit Hyperactivity Disorder (ADHD) and to Evaluate Interference Cost in Children ages 6 to 12 year old with ADHD Compared to Age-matched Controls Updated 9/9/2015 4
A Phase IV, Multicenter, Dose-Optimized, Double-Blind, Randomized, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of XXX in Pediatric Patients (Ages 6-12) with Attention Deficit Hyperactivity Disorder (ADHD) in a Laboratory Classroom A Phase I, 4-Week, Open-label, Flexible-dose Pilot Study to Explore the Optimal Dosing Effectiveness and Safety of the Triple Reuptake Inhibitor XXXin the Treatment of Adults with Attention-Deficit Hyperactivity Disorder / An Exploratory, Open-Label Pilot Study Of Flexible Doses of the Triple Reuptake Inhibitor XXX in the Treatment of Adult Males With Attention- Deficit Hyperactivity Disorder - 5-week, flexible-dosage open trial, initiated with 1 week of single-blind placebo treatment and followed by 4 weeks of open treatment with XXX A Phase II, Randomized, Double-blind, Placebo-controlled, Forced Titration, Proof-of-Concept Study of XXX in the Treatment of Attention Deficit Hyperactivity Disorder in Children (ages 6-17) A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel group study of XXX Extended-Release Oral Disintegrating Tablets (equivalent to 20, 30, 40, or 60 mg of XXX ) in children (ages 6-12 years) with attention-deficit hyperactivity disorder A Phase II, Randomized, Double-blind, Parallel-group, Multicenter Efficacy and Safety Study of XXX versus Placebo in Adults with Attention Deficit Hyperactivity Disorder (ADHD) A Multicenter, Dose-Optimized, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy of XXX in Pediatric Patients with Attention Deficit Hyperactivity Disorder (ADHD) in a Laboratory Classroom A Phase IV, Randomized, Double-Blind, Multicenter, Parallel Group, Active-Controlled, Dose- Optimization Safety and Efficacy Study of XXX Compared with XXX with a Placebo Reference Arm, in Adolescents Aged 13-17 Years with Attention-Deficit/Hyperactivity Disorder (ADHD) A Phase IV, Randomized, Double-Blind, Multicenter, Parallel-Group, Active-Controlled, Forced-Dose Titration, Safety and Efficacy Study of XXX Compared with XXX with a Placebo Reference Arm, in Adolescents Aged 13-17 Years with Attention-deficit/ Hyperactivity Disorder (ADHD) A Phase II, Double-blind, Randomized, Placebo-controlled, Multicenter, Fixed-dose Study to Assess Efficacy, Safety, and Tolerability of XXX in Adults with Inattentive-Predominant Attention Deficit/Hyperactivity Disorder (ADHD) A Phase II, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Proof-of- Concept Study of XXX in Adult Males with Attention-Deficit/Hyperactivity Disorder (ADHD) Updated 9/9/2015 5
A 40-week, Double blind, Placebo controlled, Multi-center, Randomized Withdrawal Study to Evaluate the Long Term Efficacy of XXX Extended Release in Children and Adolescents with ADHD A Phase III, parallel, randomized, double-blind, multi-center, placebo-controlled, forced dose study to evaluate the safety and efficacy of XXX extended release capsules in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric and adolescent patients aged 6 up to 18 years. A 6-month, Open-label Extension to a 40-week, Randomized, Double-blind, Placebo-controlled, Multicenter Efficacy and Safety Study of XXX in the treatment of Adult Patients with Childhood-onset ADHD A Phase IIIb, Randomized, Double-blind, Multi-center, Placebo-controlled, Dose optimization, Crossover, Analog Classroom, Safety and Efficacy Study of XXX in Adolescent Subjects Aged 13-17 with Attention-Deficit/Hyperactivity Disorder (ADHD) A 40-week, randomized, double-blind, placebo-controlled, multicenter efficacy and safety study of XXX in the treatment of adult patients with childhood-onset ADHD A Phase I/IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety, and Efficacy of a Single Dose of XXX in Adults with Attention Deficit Hyperactivity Disorder (ADHD) A Phase III, Double-Blind, Randomized, Multi-centre, Placebo-Controlled, Dose-optimization Study Evaluating the Safety, Efficacy, and Tolerability of Once-daily Dosing with Extended- Release XXX in Adolescents Aged 13-17 years Diagnosed With Attention Deficit/Hyperactivity Disorder (ADHD) A Phase III, Double-blind, Placebo-Controlled, Multi-centre, Randomized-Withdrawal, Long- Term Maintenance of Efficacy and Safety Study of Extended-release XXX in Children and Adolescents Aged 6-17 With Attention-deficit/Hyperactivity Disorder A Phase IV, Randomized, Double-Blind, Multi-center, Placebo-controlled, Parallel Group Study Evaluating the Safety and Efficacy of XXX on Executive Function (Self-Regulation) Behaviors in Adults with Attention-Deficit/Hyperactivity Disorder (ADHD) Reporting Clinically Significant Impairment of Real-World Executive Function Behavior A Double-Blind, Randomized, Placebo-Controlled, Multi-center, Fixed Dose Titration Study to Assess Efficacy, Safety, and Tolerability of XXXin Adults with Attention Deficit/Hyperactivity Disease (ADHD) Updated 9/9/2015 6
A Phase II, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of XXXas Adjunctive Therapy in the Treatment of Adult Attentiondeficit/Hyperactivity A Phase III, Double-blind, Randomized, Multi-Center, Placebo controlled, Dose Optimization Study Evaluating the Tolerability and Efficacy of AM and PM Once Daily Dosing with Extended-release XXX in Children Aged 6-12 with a Diagnosis of Attention- Deficit/Hyperactivity Disorder A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, Multicenter Study of 3 Dosages of XXX in the Treatment of Adult Subjects With Attention- Deficit/Hyperactivity Disorder A Placebo-controlled, Double-Blind, Parallel-Group, Individualized Dosing Study Optimizing Treatment of Adults with Attention Deficit Hyperactivity Disorder to an Effective Response with XXX A Phase IV, Double-Blind, Multi-Center, Placebo-Controlled, Randomized Withdrawal, Safety and Efficacy Study of XXX in Adults Aged 18-55 with Attention-Deficit/Hyper-activity Disorder (ADHD) A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Forced-Dose Titration, Safety and Efficacy Study of XXX in Adolescents Aged 13-17 with Attention-Deficit/Hyperactivity Disorder (ADHD) with Weekly Visits A Follow-Up Extension, Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Forced-Dose Titration, Safety and Efficacy Study of XXX in Adolescents Aged 13-17 with Attention-Deficit/Hyperactivity Disorder (ADHD) with Weekly Visits for the First Month and Monthly Over Approximately One Year A Randomized, Multi-Center, Double-Blind, Placebo-Controlled, 3x3 Cross-Over Study Demonstrating Superior Efficacy of XXX Versus XXX in children, Aged 6-12 Years, with Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multi-Center, Dose Optimization Study Evaluating the Efficacy and Safety of XXX in Combination with Psychostimulants in Children and Adolescents Aged 6-17 with a Diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD) A Phase III, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Parallel-Group, Safety and Efficacy Study of XXX with an Open Label Extension in Adolescents with Attention- Deficit Hyperactivity Disorder (ADHD) Updated 9/9/2015 7
A Phase III, Multi-Center, 12-Month, Open Label Safety Study of XXX in Adults with Attention-Deficit Hyperactivity Disorder. A Phase III, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Parallel-Group, Safety and Efficacy Study of XXX in Adults with Attention-Deficit Hyperactivity Disorder. A 12-Month Open Label Study of XXX in Children with Attention Deficit Hyperactivity Disorder A Multi-Center, Double-Blind, Three Arm, Parallel-Group Study Comparing the Efficacy of Immediate Release XXX and Modified Release with Placebo in Children with Attention Deficit Hyperactivity Disorder A Multi-Center, Open Label Trial of the Safety of XXX for 12 Months in Adults with Attention Deficit Hyperactivity Disorder A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Four Weeks Duration of the Efficacy and Safety of Three Doses of XXX Compared to Placebo in Adults with Attention Deficit Hyperactivity Disorder A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of XXX in Children with Attention Deficit Hyperactivity Disorder A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of XXX in Adults with Attention Deficit Hyperactivity Disorder Anxiety An Interventional, randomised, double-blind, parallel-group, placebo-controlled, flexible-dose study of XXX as adjunctive treatement to XXX or XXX in adult patients suffering from posttraumatic stress disorder (PTSD) A Phase III, Double-Blind, Placebo-Controlled, Flexible-Dose Study of XXX in Patients with Generalized Anxiety Disorder A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of a Single Dose of XXX in Acute Treatment of Adults with Generalized Anxiety Disorder A Double-Blind, Randomized, Placebo and Active-Controlled, Multi-Center Study Examining the Efficacy and Safety of XXX in Subjects with GAD Updated 9/9/2015 8
A Multi-Center, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of the Efficacy and Safety of XXX Compared with Placebo as an Adjunct to Treatment in Patients with Generalized Anxiety Disorder who Demonstrate Partial or No Response to Selective Serotonin Reuptake Inhibitor or Serotonin-Norepinephrine Reuptake Inhibitor Alone or in Combination with Benzodiazepine A Randomized, Double-Blind, Placebo and Active Comparator Controlled, Parallel-Group Safety and Efficacy Study of XXX in Adults with Generalized Anxiety Disorder A Long-Term, Open Label Safety and Efficacy Study of XXX in Adults with Generalized Anxiety Disorder. A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Two Flexible Dosing Regimens of XXX in Subjects with DSM-IV Defined Generalized Anxiety Disorder. An Eight-Week, Double-Blind, Placebo-Controlled, Multi-Center Study with XXX as Positive Control, Evaluating the Efficacy, Safety, Tolerability of a Fixed Dose of XXX in Outpatients with Generalized Anxiety Disorder. A Double-Blind Placebo-Controlled Study of XXX in the Treatment of Adults with ADHD and Comorbid Social Anxiety Disorder. A Four-Week, Double-Blind, Placebo and Active Controlled, Dose-Ranging Study of XXX, Three Doses and XXX in Outpatients with Generalized Anxiety Disorder A Double-Blind, Placebo-Controlled Study of XXX in Children and Adolescents with Generalized Anxiety Disorder A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Fixed Dose Study of the Efficacy, Safety and Tolerability of XXX Extended Release Compared to Placebo in Patients with Generalized Anxiety Disorder A Flexible Dose Comparison of the Safety and Efficacy of XXX and Placebo in the Treatment of Generalized Anxiety Disorder A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial of the Safety and Efficacy of XXX as Add-On Therapy with XXX or XXX in the Treatment of Acute Mania A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Flexible Doses of XXX in the Treatment of Hospitalized Patients with Acute Mania A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Two Fixed Doses of XXX in the Treatment of Hospitalized Patients with Acute Mania Updated 9/9/2015 9
A Multi-Center, Randomized, Placebo-Controlled Trial of the Safety and Efficacy of XXX as Add-On Therapy with XXX or XXX in the Treatment of Acute Mania A Phase III, Randomized, Placebo-Controlled Study Evaluating the Safety and Outcome of Treatment with Oral XXX in Subjects with Mania Who Are Receiving XXX A Randomized, Double-Blind, XXX-and Placebo-Controlled Study of the Efficacy and Safety of XXX in Outpatients with Generalized Anxiety Disorder A Study Evaluating the Safety and Outcome of Treatment with Oral XXX in Subjects with Mania Who Are Receiving XXX An Open Label Extension Study of the Safety and Efficacy of XXX in Patients with Generalized Anxiety Disorder An Open Label Study of the Safety, Tolerability and Efficacy of XXX in Patients with Generalized Anxiety Disorder A Study of XXX in the Treatment of Signs and Symptoms of Mania in Elderly Patients with Dementia The Efficacy and Safety of Single Dose Ranges of XXX vs. Placebo in the Treatment of Manic Episodes Associated with Bipolar Disorder I A Double-Blind, Multi-Center, Placebo-Controlled Study of XXX vs. XXX in the Treatment of Outpatients with Generalized Anxiety Disorder Bipolar Disorder A Double-Blind, Placebo-Controlled Study of XXX in Bipolar Depression A 24-Week, Flexible-Dose, Open-Label Extension Study of XXX for the Treatment of Bipolar I Depression A Multi-Center Randomized, Double Blind, Placebo-Controlled, Parallel-Group Study of XXX in the Treatment of Depression in Outpatients with Bipolar Disorder. A Multi-Center, Double-Blind, Randomized Placebo-Controlled Double-Dummy Trial of the Use of XXX in the Treatment of Patients with Bipolar Depression A Controlled Trial of Safety and Efficacy of XXX vs. Placebo in Patients with Bipolar Depression Updated 9/9/2015 10
A Controlled Trial of XXX vs. Placebo in Patients with bipolar Disorder in Manic or Mixed States A Six-Week, Double-Blind, Multicenter, Placebo-Controlled Study Evaluating the Efficacy and Safety of Flexible Doses of Oral XXX as Add-On, Adjunctive Therapy with XXX, XXX, or XXX in Bipolar I Depression A Three-Week Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Safety and Efficacy Study of Extended Release XXX in XXX Failure Patients with Bipolar Disorder A Three-Week Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Safety and Efficacy Study of XXX in the Treatment of Bipolar Disorder A Randomized, Double-Blind, Placebo-Controlled Study to Explore the Efficacy and Safety of XXX Long-Acting Intramuscular Injectable in the Prevention of Mood Episodes in Bipolar I Disorder, with Open Label Extension A Phase III, Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Safety and Efficacy of Sublingual XXX vs. XXX and Placebo In-Patients with an Acute Manic Episode A Double-Blind, Nine-Week Extension Study Evaluating the Safety and Maintenance of Effect of XXX vs. XXX in the Treatment of Subjects with Acute Mania A Phase IIIb, Open Label Observational Safety Study of Extended-Release XXX Used in Combination with Other Psychotropic Medications for the Treatment of Bipolar I Disorder A Phase IIIb, Randomized, Double-Blind, Parallel-Group Study in Bipolar I Patients to Assess the Efficacy and Safety of XXX Administered Once-Daily vs. Twice-Daily in the Treatment of Manic Symptoms An Extension Study to Evaluate the Long-Term Safety and Tolerability of XXX in the Treatment of Outpatients with Bipolar Disorder A Six-Month, Open Label, Multi-Center Study of XXX in Patients with Bipolar Disorder A Multi-Center, Randomized, Double-Blind Study of XXX vs. Placebo in the Treatment of Acutely Manic Patients with Bipolar Disorder A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Flexible Doses of XXX in the Maintenance of Treatment of Patients with Bipolar Disorder A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of XXX in the Maintenance Treatment of Patients with Bipolar Disorder Updated 9/9/2015 11
A Multi-Center, Randomized, Double-Blind, Study of XXX vs. Placebo in the Treatment of Acutely Manic Patients with Bipolar Disorder A Nine-Week, Open Label, Multi-Center Trial of Flexible Dose Ranges of XXX in the Treatment of Manic Episodes Associated with Bipolar I Disorder A Phase III, Three-Week, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Safety and Efficacy Study of XXX in the Treatment of Bipolar I Disorder A Three-Week Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Safety and Efficacy Study of Extended Release XXX in Patients with Bipolar Disorder A Comparison of the Safety and Efficacy of XXX and XXX in the Treatment of Bipolar Disorder An XXX vs. Placebo as Add-On Treatment in Subjects with Bipolar Disorder in the Outpatient Setting An XXX vs. Placebo in the Prevention of Relapse in Bipolar Disorder An XXX vs. XXX in the Treatment of Bipolar I Disorder, Manic or Mixed An Evaluation of the Safety and Efficacy of XXX Compared to Placebo and XXX in the Treatment of an Acute Manic or Mixed Episode in Patients Who Have Bipolar Disorder Depression A Phase III, Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal XXX Plus an Oral Antidepressant in Adult Subjects with Treatment-resistant Depression A Phase III, Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal XXX Plus an Oral Antidepressant in Adult Subjects with Treatment-resistant Depression - Trial of Rapid-acting Intranasal XXX for Treatment-resistant Major Depressive Disorder A Phase III, Double-blind, Placebo- and Active-Controlled Evaluation of the Safety and Efficacy of XXX in Adolescent Patients with Major Depressive Disorder A Multicenter, Randomized, Double-blind, Placebo-Controlled, Relapse-Prevention Study With XXX in Patients With Major Depressive Disorder A Phase II, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of XXX as an adjunctive therapy in patients with major depressive disorder with an inadequate response to antidepressant treatment Updated 9/9/2015 12
A Phase III Efficacy and Safety Study of XXX for the Adjunctive Treatment of Major Depressive Disorder A Phase III Multicenter Study of the Long-term Safety and Tolerability of XXX for the Adjunctive Treatment of Major Depressive Disorder in Adults who Have an Inadequate Response to Antidepressant Therapy A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of XXX in Major Depressive Disorder APhase II, 8-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy and Safety of XXX Administered Once Daily in Patients with Major Depressive Disorder A Phase III, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Titration, Efficacy and Safety Study of XXX in Combination with an Antidepressant in the Treatment of Adults with Major Depressive Disorder with Inadequate Response to Prospective Treatment with an Antidepressant A Randomized, 6-week, Double-Blind, Placebo-Controlled, Flexible-Dose, Parallel-Group Study of XXX For the Treatment of Major Depressive Disorder with Mixed Features A Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Study to Investigate the Safety and Efficacy of 20 mg XXX versus Placebo in Adult Subjects with Major Depressive Disorder Followed by a 52-week Open-label Extension A Phase III, Open-label, Multicenter, 12-month Extension Safety and Tolerability Study of XXX in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder With Residual Symptoms or Inadequate Response Following Treatment With an Antidepressant A 12-week, Open-Label Extension Study For the Treatment of Major Depressive Disorder with Mixed Features An 8-week, Randomized, Double- Blind, Placebo-Controlled, Parallel-Group, Multi-center Study of the Efficacy and Safety of XXX Sublingual Tablets Administered Once Daily in Patients with Major Depressive Disorder (MDD) A Multi-center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Phase III, Efficacy and Safety Study of 3 Fixed Dose Groups of XXX as an Adjunct to an Antidepressant in Patients with Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy Updated 9/9/2015 13
A Multi-center, Randomized, Double-Blind, Parallel Group, Active-controlled and Placebocontrolled Efficacy and Safety Study of XXX in Subjects with Major Depressive Disorder A Phase II, Multi-center, Randomized, Double-Blind, Parallel-group, Placebo-controlled Exploratory Efficacy and Safety Study of XXX in Adults 18-55 years with Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed Dose Study Evaluating the Efficacy and Safety of XXX in Subjects with Major Depressive Disorder A Phase II, Six-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Assessment of the Efficacy, Safety, Tolerability, and Steady-State Pharmacokinetics of XXX in Subjects with Major Depressive Disorder A Randomized, Double-Blind, Placebo-Controlled Parallel-Group, Assessment of the Efficacy, Safety and Tolerability of XXX TID in Subjects with Major Depressive Disorder A Randomized Double Blind, Parallel Group, Placebo Controlled, Active Referenced, Fixed- Dose Study Comparing the Efficacy and Safety of Two Doses of XXX in Acute Treatment of Adults with Major Depressive Disorder A Long-Term, Open-Label Study of XXX in Adult Patients with Major Depressive Disorder A One-Year Open Label Study Assessing the Safety of XXX in Patients with Major Depressive Disorder A Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Multi-Center Study Examining the Safety, Efficacy and Tolerability of XXX in Subjects with SSRI Resistant Major Depressive Disorder A Phase IIa Multi-Center, Randomized Double-Blind, Double-Dummy, and Placebo- and Active-Controlled Study to Investigate the Safety and Efficacy of XXX Administered to Subjects with Major Depressive Disorder A 52-Week, Multi-Center, Open Label Study Evaluating the Long-Term Safety and Tolerability of XXX in Adult and Elderly Subjects with Major Depressive Disorder. A Two-Week, Double-Blind, Placebo-Controlled Study of XXX in the Treatment of Severe Major Depressive Disorder A Double-Blind Comparison of the Safety and Efficacy of XXX and XXX in the Treatment of XXX Non-Responders Updated 9/9/2015 14
A Double-Blind, Multi-Center, Placebo- and Active- Controlled, Acute and Extension Study of XXX in the Treatment of Major Depressive Disorder A Double-Blind, Placebo- and XXX-Controlled, Multi-Center Study Evaluating the Efficacy of XXX in Patients with Major Depressive Disorder A Double-Blind, Placebo-Controlled, Multi-Center Study of the Long-Term Efficacy of XXX in the Maintenance of Antidepressant Effect In-Patients with Major Depressive Disorder A Flexible Dose Comparison of the Safety and Efficacy of XXX and Placebo in the Treatment of Major Depressive Disorder A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of XXX or XXX in the Treatment of Patients with Moderate Depression A Phase IIb, Six-Week, Double-Blind, Placebo- and XXX-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Oral XXX in Out-Patients with MDD A Phase III Open Label Study of the Safety and Efficacy of XXX in Patients with Major Depressive Disorder with Psychotic Features Who Have Previously Demonstrated a Rapid Response to XXX or Placebo in Study XXX or XXX A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of XXX in Patients with Major Depressive Disorder with Psychotic Features A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of XXX in Patients with Major Depressive Disorder with Psychotic Features Who Are Not Receiving Antidepressants or Antipsychotics A Six-Week, Double-Blind, Extension of a Phase II, Double-Blind, Placebo- and XXX- Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Oral XXX in Outpatients with Major Depressive Disorder An Eight-Week, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Two Doses of XXX and XXX in Subjects with Major Depressive Disorder A Double-Blind, Placebo- and XXX-Controlled, Multi-Center, Dose Ranging Study Evaluating the Efficacy and Safety of XXX in Outpatients with Severe Major Depressive Disorder A Fixed Dose Study of Oral XXX and XXX in the Treatment of Outpatients with Moderate Depression The Maintenance of Antidepressant Effect of XXX in Geriatric Outpatients An XXX vs. Placebo vs. XXX in the Acute Treatment of Major Depression Updated 9/9/2015 15
A Double Blind, Placebo-Controlled, Multi-Center Study of the Long-Term Efficacy of XXX in the Maintenance of Antidepressant Effect in Geriatric Outpatients with Major Depressive Disorder A Phase III, Open Label Study of Safety, Tolerability, and Efficacy of the XXX in Elderly Subjects with Major Depressive Disorder An Open Label Extension Study of the Safety and Efficacy of XXX in Patients with Major Depressive Disorder Schizophrenia An Open-Label, Long-Term Safety and Tolerability Study of XXX in the Treatment of Subjects With Schizophrenia A 12-week, Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of XXX in the Acute Treatment of Adults With Schizophrenia A 12-week, Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of XXX in the Acute Treatment of Adults With Schizophrenia Evaluation of the Long-Term Safety, Tolerability and Pharmacokinetics of XXX in Patients with Schizophrenia A Double-Blind, Placebo and Active-Controlled Evaluation of the Safety and Efficacy of XXX in the Acute Exacerbation of Schizophrenia A 52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of as Maintenance Treatment in Patients with Schizophrenia A Phase II, 6-week, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of XXX Once Daily and XXX Once Daily for Treatment of Hospitalized Adult Patients with Acute Schizophrenia AND Extension Study, A Phase II, Multi-center, Open-label Study to Assess the Safety and Tolerability of XXX Flexibledosed as Monotherapy in Adult Patients with Schizophrenia A Phase III, Randomized, Placebo- and Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Two Doses of XXX in Acutely Psychotic Subjects with Schizophrenia A 38-week, Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of XXX as Maintenance Treatment Updated 9/9/2015 16
A Multi-Center, Double-Blind, Randomized, Placebo-controlled, Study to Evaluate the Longterm Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of XXX in Patients with Schizophrenia A Phase III, Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Efficacy of Three Doses of XXX in Acutely Psychotic Patients with Schizophrenia A Randomized, Double-Blind, Placebo- and XXX-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety and Tolerability of XXX Given BID for 28 Days to Schizophrenic Patients in Acute Exacerbation Followed by a Long-Term Treatment Phase A Six-Week, Multi-Center, Double-Blind, Double-Dummy, Randomized Comparison of the Efficacy and Safety of Sustained Release Formulation XXX and Placebo in the Treatment of Acutely Ill Patients with Schizophrenia A Multi-center, Randomized, Double-Blind, Fixed-Dose, Six-Week Trial of the Efficacy and Safety of XXX Compared with Placebo Using XXX Positive Control in Subjects with Acute Exacerbation Schizophrenia A Six-Week, Double-Blind, Randomized, Fixed Dose, Parallel-Group Study of Efficacy and Safety of Three Dose Levels of XXX Compared to Placebo and XXX in Patients with Schizophrenia Who Are Experiencing an Acute Exacerbation of Symptoms A Controlled Trial of XXX vs. XXX in the Treatment of Schizophrenic and Schizoaffective Subjects with Prominent Negative Symptoms A Controlled Trial of XXX vs. XXX in the Treatment of Schizophrenic and Schizoaffective Subjects with Comorbid Depression A Double-Blind, Randomized, Fixed Dose, Placebo-Controlled, Parallel-Group, Six-Week, Efficacy, Safety and Tolerability Study of Two Dose Levels of XXX in Patients with Schizophrenia by DSM-IV Criteria Who Are Experiencing Acute Exacerbation of Symptoms A Double-Blind, Placebo and XXX-Controlled, Multi-Center Study Evaluating the Safety and Efficacy of XXX in Schizophrenic Patients A Double-Blind, Randomized, Fixed Dose, Placebo-Controlled, Parallel-Group, Six-Week Efficacy, Safety, and Tolerability Study of Two Dose Levels of XXX in Patients with Schizophrenia by DSM-IV Criteria Who Are Experiencing an Acute Exacerbation of Symptoms A Double-Blind, Randomized, Multi-Center, Parallel-Group Design Study to Evaluate the Efficacy and Safety of Two Dose Ranges of XXX in Comparison with Placebo and XXX in the Treatment of Schizophrenia Updated 9/9/2015 17
A Multi-Center, Double-Blind, Randomized Comparison of the Efficacy and Safety of Sustained-Release Formulation XXX and Placebo in the Treatment of Patients with Schizophrenia A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Three Fixed Doses of XXX in the Treatment of Patients with Acute Schizophrenia A Phase II, Six-Week, Double-Blind, Placebo- and XXX-Controlled Study Evaluating the Safety and Efficacy of Oral XXX in Schizophrenia and Schizoaffective Disorder An Open Label, Long-Term Follow-up Safety Study of XXX in Schizophrenic/ Schizoaffective Patients An Open Label, Treatment Switching Study from Orally Administered Antipsychotic Mono- Therapy to Orally Administered XXX Mono-Therapy in the Treatment of Chronic Schizophrenic and Schizoaffective Patients A Randomized, Double-Blind, Placebo- and XXX-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Two Non-Overlapping Dose Ranges of XXX Given BIP for 42 Days to Schizophrenic Patients Followed by a Long-Term Treatment Phase with XXX Given QD A Randomized, Double-Blind, Placebo- and XXX-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Two Non-Overlapping Dose Ranges of XXX Given BIP for 42 Days to Schizophrenic Patients Followed by a Long-Term Treatment Phase with XXX A Randomized, Double-Blind, Placebo-Controlled, XXX-Referenced, Dose Finding Study of XXX in the Treatment of Schizophrenia The Cost Effectiveness and Functional Outcomes XXX in the Treatment of Schizophrenia in Usual Clinical Practice: A Randomized Clinical Study The Efficacy of XXX in the Treatment of Acutely Ill Non-Compliant Schizophrenic Patients A Study of the Efficacy and Safety of XXX in Schizophrenic and Schizoaffective Patients A Multi-Center, Double-Blind, Double-Dummy, Placebo-Controlled, Randomized Parallel- Group Evaluation of the Efficacy and Safety of a Fixed Dose of XXX vs. Placebo vs. XXX in Subjects with Schizophrenia A Randomized, Open Label, Rater-Blinded, Assessment of Optimal Treatment Change Strategy to XXX for Patients Intolerant of XXX Updated 9/9/2015 18
Sleep Disorders A Double-Blind, Randomized, Multi-Center, Placebo-Controlled, Parallel-Groups, Efficacy and Safety Extension Study of XXX in the Treatment of Adult Outpatients with Primary Insomnia. A Phase III, Randomized, Double-Blind, Placebo-Controlled, Outpatient Safety and Efficacy Study of XXX in Elderly Subjects with Chronic Insomnia A Phase III, Randomized, Double-Blind, Placebo-Controlled, Outpatient Study to Assess the Efficacy and Safety of a Modified Release Formulation of XXX in Adult Primary Insomnia Patients with Sleep Maintenance Difficulties A Phase III, Open Label, Fixed Dose Study to Determine the Safety of Long-Term Administration of XXX in Subjects with Chronic Insomnia A Phase III, Randomized, Double-Blind, Placebo-Controlled, Outpatient Safety and Efficacy Study of XXX in Adults with Chronic Insomnia A Phase III, Open Label, Outpatient Extension Study to Assess the Long-Term Safety of a Modified Release Formulation of XXX in Adult Primary Insomnia Patients with Sleep Maintenance Difficulties Other Indications A Phase III, Open-Label, Safety and Tolerability Study of XXX for the Treatment of Tardive Dyskinesia A Randomized, Multicenter, Double-Blind, Placebo Controlled, Two-Arm Study Evaluating Efficacy of a Single Dose XXX (10 mg vs. Placebo) in Patients with Acute Migraine Headache With or Without Aura An Open-label Extension Study of XXX for 52 weeks in Pain Associated with Fibromyalgia A randomized, double-blind, double-dummy, placebo- and active-controlled, multi-center study of XXX in subjects with pain associated with fibromyalgia A Phase III, Randomized, Double-blind, Placebo-controlled, Parallel, Fixed-dose Study to Assess the Efficacy, Safety, and Tolerability of XXX for the Treatment of Tardive Dyskinesia A Validation Study of the Name-Face Memory Consolidation Test in Volunteers with Amnestic Mild Cognitive Impairment A Phase II Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study of XXX in Subjects with Fibromyalgia (FM) Updated 9/9/2015 19
A Randomized, Double-Blind, Double-Dummy, Active-Controlled, Cross-Over Study Evaluating the Efficacy and Safety of 20 mg XXX in Adults with Acute Migraine With or Without Aura A Phase IV, 26-Week Randomized, Double-Blinded, Active Controlled Study Comparing the Safety of XXX Fixed Dose Combination Versus XXX Monotherapy in Adolescents and Adults With Persistent Asthma A Phase IV, Flexible Dosed XXX Versus Placebo in the Treatment of Fibromyalgia A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate XXX in Patients with Alzheimer s Disease of Mild to Moderate Severity A Randomized, Open Label, Dose Blinded, Multi-Center, Six-Month Study of Safety and Tolerability of Three Dose Levels of XXX A Comparison of Efficacy and Safety of XXX, XXX, and Placebo in the Treatment of Elderly Subjects Presenting with Alzheimer s Dementia and Psychoses or Other Selected Psychoses An Open Extension Study Evaluating the Safety and Outcome of Oral XXX An Open Label Extension Study of XXX in Treatment of Signs and Symptoms of Mania in Elderly Patients with Dementia A Study of XXX (Also Known as XXX) Used in Elderly Subjects for the Prevention of Clinical Influenza During the Influenza Season Updated 9/9/2015 20
PUBLICATIONS: Morrissette D.A., Cutler A.J. Strategies for optimizing medication adherence in schizophrenia. CNS Spect. 2012;17(01):31-41 Wilens T E, Bukstein O, Brams M, Cutler A J, Childress A, Rugino T, Lyne A, Grannis K, Youcha S. A Controlled Trial of Extended-Release Guanfacine and Psychostimulants for Attention-Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry. 2011;51(1):74-85.e2 Wilens T E, Bukstein O, Brams M, Cutler A J, Childress A, Rugino T, Lyne A, Grannis K, Youcha S. A Controlled Trial of Extended-Release Guanfacine and Psychostimulants for Attention-Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry. Epub 2011 November 28. Kahn A, Cutler AJ, Kajdasz DK, Gallipoli S, Athanasiou M, Robinson DS, Whalen H, Reed CR. A randomized, double-blind, placebo-controlled, 8-week study of Vilazodone, a serotonergic agent for the treatment of major depressive disorder. J Clin Psychiatry. 2011 Apr; 72(4):441-7 Findling RL, Childress AC, Cutler AJ, Gassior M, Hamdani M, Ferreira-Cornwell MC, Squires L. Efficacy and safety of lisdexamfetamine dimesylate in adolescents with attentiondeficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2011 Apr;50(4):395-405.Epub 2011 Mar 3 Findling RL, Childress AC, Cutler AJ, Gasior M, Hamdani M, Ferreira-Cornwell MC, Squires L. Efficacy and safety of lisdexamfetamine dimesylate in adolescents with attentiondeficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2011; 50(4):395-405 Cutler AJ, Tran-Johnson T, Kalali A, Astrom M, Brecher M, Meulien D. A failed 6-week, randomized, double-blind, placebo-controlled study of once-daily extended release quetiapine fumarate in patients with acute schizophrenia: lessons learned. Psychopharmacol Bull. 2010; 43(4):37-69 Cutler AJ: Iloperidone: a new option for the treatment of schizophrenia. Expert Rev. 2009;9(12):1727-1741 Cutler AJ, Montgomery SA, Feifel D,Lazarus A, Åström M, Brecher M, Extended Release Quetiapine Fumarate Monotherapy in Major Depressive Disorder: A Placebo- and Duloxetine- Controlled Study J Clin Psychiatry. 2009;70(4):526-539 Keck PE, Orsulak PJ, Cutler AJ, Sanchez R, Torbeyns A, Marcus RN, McQuade RD, Carson WH: Aripiprazole monotherapy in the treatment of acute bipolar I mania: A randomized, doubleblind, placebo- and lithium-controlled study. J Affective Disorders. 2009;112:36-49 Updated 9/9/2015 21
PUBLICATIONS (continued): Cutler AJ, Kalali AH, Weiden PJ, Hamilton J, Wolfgang CD: Four-week, double-blind, placeboand ziprasidone-controlled trial of iloperidone in patients with acute exacerbations of schizophrenia. J Clin Psychopharmacol. 2008;28(2 Suppl 1):S20-S28 Weiden PJ, Cutler AJ, Polymeropoulos MH, Wolfgang CD: Safety profile of iloperidone. A pooled analysis of 6-week acute-phase pivotal trials. J Clin Psychopharmacol. 2008; 28(2 Suppl 1):S12-S19 Merideth C, Cutler A, Neijber A, She F, Eriksson HA: Efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) monotherapy in the treatment of generalised anxiety disorder (GAD). Eur. Neuropsychopharmacol. 2008;18(4):S499 Cutler AJ: An update of the investigational Antipsychotic iloperidone: an expert interview with Andrew J Cutler, MD. Medscape Psychiatry & Mental Health. 2008 Cutler AJ, Ball S, Stahl SM: Dosing atypical antipsychotics. CNS Spect. 2008;13:5(Suppl 9):2-16 Weisler RH, Kalali AH, Cutler AJ, Gazda TD, Ginsberg L. Safety of carbamazepine extendedrelease capsules used in combination with other psychotropic medications for the treatment of bipolar I disorder. Psychiatry (Edgmont). 2008 May;5(5):49-60 El-Mallakh RS, Ketter TA, Weisler RH, Hirschfeld R, Cutler AJ, Gazda T, Keck P, Swann AC, Kalali AH. Switching from other agents to extended-release carbamazepine in acute mania. Psychopharmacol Bull. 2008;41(1):52-8 Cutler AJ: Clinical approaches to recognizing and managing bipolar disorder. Practical Neuroscience for Primary Care Physcian. 2007;Winter:12-15 Weisler RH, Hirshfeld R, Cutler AJ, Gazda T, Ketter TA, Keck PE, Swann A, Kalali A; SPD417 Study Group. Extended-release carbamazepine capsules as monotherapy in bipolar disorder : pooled results from two randomised, double-blind, placebo-controlled trials. CNS Drugs. 2006;20(3):219-31 Cutler AJ, Marcus RN, Hardy SA, O Donnell A, Carson WH, McQuade RD: The efficacy and safety of lower doses of aripiprazole for the treatment of patients with acute exacerbation of schizophrenia. CNS Spect. 2006;11(9):691-702 Weisler RH, Cutler AJ, Ballenger JC, Post RM, Ketter TA: The use of antiepileptic drugs in bipolar disorders: a review based on evidence from controlled trials. CNS Spect. 2006;11(10):788-799 Updated 9/9/2015 22
PUBLICATIONS (continued): Goodman DW, Ginsberg L, Weisler RH, Cutler AJ, Hodgkins P: An interim analysis of the quality of life, effectiveness, safety and tolerability (QUEST) evaluation of mixed amphetamine salts extended release in adults with ADHD. CNS Spectr. 2005; 10(12 Suppl 20):26-34 Calabrese JR, Keck PE Jr., Macfadden W, Minkwitz M, Ketter TA, Weisler RH, Cutler AJ, McCoy R, Wilson E, Mullen J: A Randomized, Double-Blind, Placebo-Controlled Trial of Quetiapine in the Treatment of Bipolar I or II Depression. Am J Psychiatry. 2005; 162:1351-1360 Weisler RH, Keck PE Jr, Swann AC, Cutler AJ, Ketter TA, Kalali AH: Extended-release carbamazepine capsules as monotherapy for acute mania in bipolar disorder: a multicenter, randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2005; 66:323-330 Weislet RH, Kalali AH, Ketter TA, and the SPD417 Study Group: A multicenter, randomized, double-blind, placebo-controlled trial of extended-release carbamazepine capsules as monotherapy for bipolar disorder patients with manic episodes. J Clin Psychiatry. 2004;65(4):478-484 Cutler AJ: Sexual dysfunction and antipsychotic treatment. Psychoneuroendocrinology. 2003;28 (1):69-82 Cutler AJ, Goldstein JM, Tumas JA: Dosing and switching strategies for quetiapine fumarate. Clinical Therapeutics. 2002;24(2):209-222 Tariot PN, Schneider LS, Mintzer JE, Cutler AJ, et al: Safety and tolerability of divalproex sodium in the treatment of signs and symptoms of mania in elderly patients with dementia: results of a double-blind, placebo-controlled trial. Current Therapeutic Research, 2001;62(1):51-67 Wallace MB, Lim J, Cutler A, Bucci L: Effects of dehydroepiandrosterone vs. androstenedione supplementation in men. Med Sci Sports Exercise. 1999; 31(12):1788-92 Cutler AJ: Domestic violence. Psychiatry. 25 (11 & 12), 1996 Audio Digest Foundation Cutler AJ: Sleep apnea. Medical Update for Psychiatrists. 1996; 1(4):127-130 Cutler AJ: Asthma: recent trends in diagnosis and management. Medical Update for Psychiatrists. 1996; 1(2):34-40 Cutler AJ: Recognition and management of hypertension by psychiatric physicians. Medical Update for Psychiatrists. 1996; 1(1):5-12 Updated 9/9/2015 23
PUBLICATIONS (continued): Shaffer ER, Cutler AJ, Wellstone PD: Coverage of mental health and substance abuse services under a single-payer health care system. Hospital and Community Psychiatry. 1994; 45:916-919 Leslie CA, Robertson MW, Cutler AJ, Bennett JP: Postnatal development of D1 dopamine receptors in the medial prefrontal cortex, striatum, and nucleus accumbens of normal and neonatal 6-hydroxydopamine treated rats: a quantitative autoradiographic analysis. Developmental Brain Research. 1991; 62:109-114 POSTERS: Cutler A.J, Bose A., Durgam S., Migilore R., Wang G., Ruth A., Nemeth G., Lazlovszky I: Safety and Tolerability of Cariprazine in the Long-Term Treatment of Schizophrenia: Results From a 48-Week Extension Study; Presented at the 52 nd Annual Meeting; 29 May 1 June 2012; Phoenix, AZ Trivedi M.H., Cutler A.J., Richards C., Lasser R., Geibel B., Gao J., Sambunaris A., Patkar A.: Efficacy and Safety of Lisdexamfetamine Dimestlate as Augmentation Therapy in Adults With major Depressive Disorder Treated With an Antidepressant; Presented at the 28 th Collegium International Neuro-Psychopharmacologicum; 3-7 June 2012; Stockholm Sweden Lasser R., Richards C., Cutler A.J., Geibel B., Adeyi B.,Scheckner B., Sambunaris A., Patkar A.A., Trivedi M.: Lisdexamfetamine Dimesylate Augmentation in Escitalopram-Treated Adults With major Depressive Disorder: Item Analyses of Depressive Symptom Scales; Presented at the New Clinical Drug Evaluation Unit 52 nd 165 th Annual Meeting of the American Psychiatric Association; 5-9 May, 2012; Philadelphia, PA Cutler AJ, Muniz R: Treatment With Clonodine Extended-Release Tablets for Children and Adolescents With ADHD Who Have an Inadequate Response to Stimulants; Presented at the 24 th Annual U.S. Psychiatric and Mental Health Congress; 7-10 November 2011; Las Vegas, NV Trivedi M.H., Cutler A.J., Richards C., Lasser R., Geibel B., Gao J., Sambunaris A., Patkar A.: Efficacy and Safety of Lisdexamfetamine Dimesylate as Augmentation Therapy in Adults With Major Depressive Disorder Treated With an Antidepressant; Presented at the 63 rd Institute of Psychiatric Services; 27-30 October 2011; San Francisco, CA Cutler, A.J., Tenorio E., Muniz R.: Clonidine Extended-Release Tablets for the Treatment of ADHD in Children and Adolescents With Inadequate Response to Stimulants; Presented at the 40 th Annual Meeting of the Child Neurology Society; 26-29 October 2011; Savannah, GA Treubert P., Cutler A.J., Muniz R.: AN Extended-Release Formulation of Clonidine Hydrochloride Tablets for the Treatment of ADHD in Children and Adolescents with Inadequate Response to Stimulants; Presented at the 25 th Annual Psychiatric Nurse Association; 19-22 October 2011; Anaheim, CA Updated 9/9/2015 24