Curriculum Vitae, Conrad O. Beckles, M.S., L.M.H.C., Ph.D.

Transcription

1 CONTACT INFORMATION: Site Selection and Information: Bobbie Theodore, Alliance Director Tel. (916) Fax (208) AFFILIATIONS: Conrado Oscar Beckles, M.S., L.M.H.C., Ph.D. Florida Clinical Research Center, LLC Cooper Creek Blvd., Suite 107 Bradenton, FL Tel. (941) Manatee Glens Hospital Aspire Health Partners th Avenue East 434 West Kennedy Blvd. Bradenton, FL Orlando, FL Aspire Health Partners 100 West Columbia Street Orlando, FL EDUCATION: Ph.D., Counseling & Psychology Barry University, Orlando, Florida M.S., Counseling & Psychology Troy State University, Orlando, Florida B.A., Psychology University of Central Florida, Orlando, Florida PROFESSIONAL EXPERIENCE: Principal Investigator & Sub-Investigator, Present Florida Clinical Research Center, LLC, Bradenton, Florida Residential Coordinator, Florida United Methodist Children s Home, Enterprise, Florida Emergency Shelter Manager/Coordinator, Florida United Methodist Children s Home, Enterprise, Florida 1

2 PROFESSIONAL EXPERIENCE (continued): Emergency Shelter Therapist, Florida United Methodist Children s Home, Enterprise, Florida President, 2000 Present New Beginnings Counseling Services, Inc., Orlando, Florida Therapist / Case Manager, Horizon Behavioral Services, Lake Mary, Florida Psychiatric Placement Coordinator, Park Place Behavioral Health, Kissimmee, Florida INVESTIGATOR EXPERIENCE: Addiction Asthma Attention Deficit Hyperactivity Disorder (ADHD) Anxiety Disorder Autism Spectrum Disorder Bipolar Disorder Depression Fibromyalgia Migraine Schizophrenia Tourette s Disorder CLINICAL TRIAL EXPERIENCE: Addiction The Phase III, Multicenter, Randomized, Double-blind, Parallel-group, Placebocontrolled, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of XXX in Adults Aged 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 ADHD A Phase II,Evaluation of XXX efficacy and safety in children with ADHD - double blind, placebo controlled, dose ranging A Pivotal Study to Evaluate the Efficacy and Safety of XXX Extended-Release Tablets for Impulsive Aggression in Patients Treated for Attention-Deficit/Hyperactivity Disorder (ADHD) A Phase III, Randomized, Double-blind, Multicenter, Parallel-group, Placebo-controlled, Forced-dose Titration, Safety and Efficacy Study of XXX in Adults Aged Years with Attention-deficit/Hyperactivity Disorder (ADHD) 2

3 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) 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, Placebo-controlled, 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 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 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 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 3

4 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 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 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 Proofof-Concept Study of XXX in Adult Males with Attention-Deficit/Hyperactivity Disorder (ADHD) A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of XXX Extended-Release Tablets as Adjunctive Therapy in Children with Impulsive Aggression Comorbid with Attention- Deficit/Hyperactivity Disorder (ADHD) A 40-week, Phase IV, Double-blind, Placebo-controlled, Multicenter, Randomizedwithdrawal Study to Evaluate the Long-term Efficacy and Safety of XXX Extended- Release in Children and Adolescents with Attention Deficit Hyperactivity Disorder A Phase III, Double-blind, Randomized, Multi-center, Placebo-controlled, Doseoptimization Study Evaluating the Safety, Efficacy, and Tolerability of Once-daily Dosing with Extended-release XXX in Adolescents Aged years Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD) A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of XXX Extended-Release Tablets as Adjunctive Therapy in Children with Impulsive Aggression Comorbid with Attention-Deficit/Hyperactivity Disorder (ADHD) A Focus Group To Assess EVO Game Engagement In Children Ages 8 To 12 Years Old With And Without Attention Deficit Hyperactivity Disorder (ADHD) 4

5 Anxiety Disorder A Phase II, Randomized, Double blind, Placebo controlled, Multi center Study to Assess Safety and Tolerability of XXX in Subject 6-17 years old with Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD) or Social Phobia (SoP) Autism Spectrum Disorder An Open-Label Study of the Safety and Tolerability of XXX in Pediatric Patients with Autism, Asperger s Disorder, or Pervasive Developmental Disorder not otherwise specified (PDD-NOS) A Double Blind, Placebo-Controlled, Randomized Withdrawal Study of the Safety and Efficacy of XXX in Pediatric Patients with Autism, Asperger s Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Previously Treated with XXX An Open-Label Extension of the Safety and Tolerability of XXX in Pediatric Patients with Autism, Asperger s Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Bipolar Disorder A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of XXX Monotherapy in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of XXX Adjunctive to Lithium or Valproate in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder A Multicenter, Double-Blind, Fixed-Dose, Long-Term Extension Trial of the Safety of XXX in Subjects Diagnosed with Bipolar 1 Disorder who Completed Protocol XXX A Phase IIIb, Multicenter, Double-Blind, Fixed-Dose, Parallel-Group, Three Week Placebo Controlled Trial Evaluating the Safety and Efficacy of XXX in Subjects With Bipolar I Disorder Experiencing an Acute Manic or Mixed Episode A Phase III Multicenter, Open Label, Flexible-Dose Extension Study of XXX Adjunctive to XXX or XXX In Subjects With Bipolar I Disorder 5

6 A randomized, Double-Blind, Placebo-Controlled, Flexible-Dose, Parallel-Group Study of XXX to XXX or XXX for the Prevention of Recurrence in Subjects with Bipolar I Disorder Depression A Phase III, 8-Week Prospective Randomized, Controlled, Single-Blind Trial of the XXX vs. Treatment-as-Usual to Evaluate Efficacy of Assay-Guided Treatment in Adults with Major Depressive Disorder 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 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 Phase 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 6

7 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 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 12-week, Open-Label Extension Study For the Treatment of Major Depressive Disorder with Mixed Features 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 XXX Versus Placebo in Adult Subjects with Major Depressive Disorder Followed by a 52-Week Open-Label Extension 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 Other Indications A Phase II, Open Label Trial to Evaluate the Safety of XXX Administered Intravenously in Patients with Migraine A Phase II, Parallel Group, Double-Blind, Randomized, Placebo Controlled, Trial to Evaluate the Efficacy and Safety of XXX Administered Intravenously in Patients with Migraines 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 7

8 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 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 II Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study of XXX in Subjects with Fibromyalgia (FM) 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 Validation Study of the Name-Face Memory Consolidation Test in Volunteers with Amnestic Mild Cognitive Impairment Validation Study of the Aggression Diary Schizophrenia An Open-Label, Long-Term Safety and Tolerability Study of XXX in the Treatment of Subjects With Schizophrenia A Phase III Multicenter, Double-Blind, Fixed-Dose, Long-Term Extension Trial of the Safety of XXX using XXX as an Active Control in Subjects Diagnosed with Schizophrenia who completed Protocol XXX A Phase IIIb Multicenter, Randomized, Double-Blind, Fixed-Dose, 6-Week Trial of the Efficacy and Safety of XXX Compared With Placebo Using XXX A 12-week, Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of XXX in the Acute Treatment of Adults With Schizophrenia A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase 2 Study of the Safety and Efficacy of XXX in the Treatment of Cognitive Deficits in Schizophrenia (CDS) in Smokers A Phase III, Randomized, Multicenter, Double-Blind, Non-inferiority Study of XXX 3 Month and 1 Month Formulations for the Treatment of Subjects with Schizophrenia 8

9 A Phase III, 12-Week, Multicenter, Open-Label Extension Study In Subjects with Schizophrenia A Double-blind, Placebo-controlled, Randomized Withdrawal Study of XXX for the Maintenance Treatment of Subjects with Schizophrenia Tourette s Disorder A Phase III Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily XXX in Children and Adolescents with Tourette s Disorder An Phase III Open-Label, Multicenter Study Evaluating the Safety and Tolerability of Once-daily XXX in Children and Adolescents with Tourette s Disorder 9