CONTACT INFORMATION: Site Selection and Information: Bobbie Theodore, Site Liaison Tel. (916) 939-6696 Fax (208) 575-3169 Email: clinicaltrials@alliancesites.com AFFILIATIONS: Carmen Zegarra, M.D. FutureSearch Clinical Trials, L.P. 5508 Parkcrest Drive, Suite 300 Austin, TX 78731 Brodie Ranch Rehabilitation and Healthcare Center Inpatient Facility 2101 Frate Barker Road Austin, TX, 78748 EDUCATION: 2001 Acupuncture Training St. Luke s Hospital, Academy of Pain Research, San Francisco, CA 1992 1993 Short Term Psychodynamic Therapy Training New Jersey Institute of Psychodynamic Therapy, Paramus, NJ July 1989 June 1992 Residency Training PGY-II-IV Bergen Pines County Hospital, Paramus, NJ July 1988 June 1989 Residency Training PGY-I Bronx-Lebanon Hospital Center, Bronx, NY 1973 1980 Physician Surgeon, M.D. Federico Villarreal National University, Lima, Peru CERTIFICATION: Board Certified Adult Psychiatry American Board of Psychiatry and Neurology - 1 -
LICENSURE: Texas Medical License #M8450 New Jersey Medical License #MA55807 New York Medical License #187550 RATER CERTIFIED: ADHD-RS-IV C-SSRS VAS PWC BARS/AIMS/SAS EQ-5D NSA-16 SCID BPRS HAM-A PANSS WRAADS CAADID MADRS PROs CGI-S CDSS MINI PSP CGI-I PROFESSIONAL EXPERIENCE: Investigator, September 2012 Present FutureSearch Clinical Trials, LP, Austin, TX Staff Psychiatrist at PES & Outpatient Services, February 2008 December 2012 Austin Travis County Integral Care (ATCMHMR), Austin, TX Psychiatrist, January 2002 December 2007 Private Practice, Montclair, NJ Medical Director, Outpatient Services, September 1998 January 2008 St. Mary s Hospital, Passaic, NJ Preceptor of Clinical Psychiatry, 1997 2002 University of Medical and Dentistry of New Jersey, Newark, NJ Medical Director, Inpatient Services, August 1997 August 1998 St. Mary s Hospital, Passaic, NJ Staff Psychiatrist, August 1993 August 1997 St. Mary s Hospital, Passaic, NJ Staff Psychiatrist, June 1992 June 1993 Jersey City Medical Center, Jersey City, NJ Consultant Psychiatrist, 1991 1993 Mental Health Clinic of Passaic, Passaic, NJ Consultant Psychiatrist, Emergency Services, 1991 1992 Elizabeth General Medical Center, Elizabeth, NJ - 2 -
INVESTIGATOR EXPERIENCE: ADHD Bipolar Disorder Pediatric Anxiety Pediatric Bipolar Disorder Addictions Depression Fibromyalgia Obsessive Compulsive Disorder Schizophrenia and Schizoaffective Disorder CLINICAL TRIAL EXPERIENCE: Addictions A multi-center, multi-region, observational Smoking Cessation study to understand the biological or functional changes related to Smoking Cessation in apparently healthy smokers who are continuously abstinent from smoking for one year A Phase III, multi center, double blind, placebo controlled, randomized withdrawal study to evaluate the maintenance and efficacy of XXX in adults aged 18-55 with moderate to severe binge eating A Twelve-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study with Follow-up Evaluating the Safety and Efficacy of XXX for Smoking Cessation in Healthy Adolescent Smokers A Phase IV, Randomized, Double Blind, Active and Placebo Controlled, Multicenter Study Evaluating the Neuropsychiatric Safety and Efficacy of 12 weeks XXX and XXX for Smoking Cessation in Subjects with and without a History of Psychiatric Disorders A Phase IV, Randomized, Double Blind, Active And Placebo Controlled Multicenter Study Evaluating The Neuropsychiatric Safety And Efficacy Of 12 Weeks XXX And XXX For Smoking Cessation In Subjects With And Without A History of Psychiatric Disorders A Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Doseoptimization 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 ADHD Pediatric and Adult 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 - 3 -
A Phase III Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Efficacy and Safety Study of 2 Doses of XXX in Adults with Attention Deficit Hyperactivity Disorder (ADHD) A Interventional, Randomised, Double-blind, Placebo-controlled, Fixed-dose Study of XXX in adults with Attention Deficit Hyperactivity Disorder (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 A 6-week Randomized, Multicenter, Double-blind, Parallel, Fixed-dose Study of XXX 1400 mg Compared with Placebo in Adults with Attention Deficit/Hyperactivity Disorder (ADHD) 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 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 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) Bipolar Disorder Pediatric and Adult A Phase III, 52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of an Intramuscular Depot Formulation of XXX as Maintenance Treatment in Patients with Bipolar I Disorder A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of XXX as Maintenance Treatment in Patients with Bipolar I Disorder A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept, Phase II Study to Evaluate the Efficacy and Safety of Once a Day, XXX Tablet for Sublingual Administration XXX in the Treatment of Acute Depressive Episodes Associated with Bipolar I Disorder in Adult Patients who are on Lithium and/or Valproate - 4 -
Efficacy Safety of 3-Week Fixed-Dose XXX Treatment in Pediatric Acute Manic or Mixed Episodes Associated with Bipolar I Disorder A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept, Phase II Study to Evaluate the Efficacy and Safety of Once a Day, XXX as an Adjunctive Therapy to Treatment-as-Usual in the Maintenance Treatment of Bipolar I Disorder in Adult Patients Depression A Randomized, Double-Blind, Placebo-Controlled, Phase IV, Relapse Prevention Study Evaluating the Efficacy and Safety of XXX (5, 10 and 20 mg) in Adults With Major Depressive Disorder A Phase III Open-label Long-term Safety Study of XXX in Pediatric Patients With Major Depressive Disorder A Phase III Multicenter, Double-blind, Placebo- and Active-Controlled Parallel-Group Evaluation of the Safety and Efficacy of XXX in Pediatric Patients With 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 III, Efficacy and Safety Study of XXX for the Adjunctive Treatment of Major Depressive Disorder A Phase III, Exploratory, Multicenter, Open-label, Flexible-dose Trial of XXX as an Adjunctive Treatment of Adults with Major Depressive Disorder Who Are in School or at Work An Interventional, randomised, double-blind, parallel-group, placebo-controlled, flexible-dose long-term study to evaluate the maintenance of efficacy and safety of 1 to 3 mg/day of XXX as adjunctive treatment in patients with major depressive disorder with an insufficient response to antidepressant treatment A Phase III Double-blind, Placebo-controlled Study of XXX as Adjunctive Therapy in Major Depressive Disorder A Phase III, Long-Term, Open-Label Study of Safety and Tolerability of XXX as Adjunctive Therapy in Major Depressive Disorder An Exploratory, Multicenter, Open-label, Flexible-dose Trial of XXX as an Adjunctive Treatment of Adults With Major Depressive Disorder and Anxiety Symptoms - 5 -
A Double-Blind, Placebo-Controlled, Randomized Add-On Study of XXX for Patients With Major Depressive Disorder (MDD) Who Have Had An Inadequate Response to Current Antidepressant Therapy A Phase III, Open-Label Extension Study to Assess the Safety and Tolerability of Treatment With XXX in Patients Who Have Completed Study XXX An Interventional, open-label, long term extension study to evaluate the safety and tolerability of XXX as adjunctive treatment in patients with major depressive disorder A Phase III Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of XXX vs. Placebo in the Treatment of Psychotic Symptoms in Patients with Major Depressive Disorder with Psychotic Features A Phase III, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of XXX in Adolescent Patients With Major Depressive Disorder A Phase III, Interventional, randomised, double-blind, parallel-group, placebo-controlled, fixeddose study to evaluate the efficacy and safety of XXX (1 and 3 mg/ day) as adjunctive treatment in elderly patients with major depressive disorder with an inadequate response to antidepressant treatment A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of XXX in Major Depressive Disorder Fibromyalgia A Phase II,Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study of XXX in Subjects with Fibromyalgia Schizophrenia A randomized, double-blind, placebo- and active-controlled, multi-center study to assess the antipsychotic efficacy of XXX in patients with schizophrenia. A Phase II randomised, double-blinded, placebo-controlled study to evaluate the efficacy, safety, and tolerability of 10 mg, 25 mg, 50 mg, and 100 mg once daily oral administration of XXX during a 12-week treatment period in patients with schizophrenia on stable antipsychotic treatment An Open-Label, Long-Term Safety and Tolerability Study of XXX in the Treatment of Subjects With Schizophrenia - 6 -
A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of XXX (90-mg and 120 mg) as a Treatment in Subjects with Acute Schizophrenia Over 8 Weeks (2 Subcutaneous Doses) and Long term safety, and tolerability of XXX in stable schizophrenia subjects A Phase III, An Exploratory, Multicenter, Open-label, Flexible-dose XXX Trial in Adults with Acute Schizophrenia Associated Cognitive Impairment A 12-Week, Randomized, Phase II, Double-blind, Parallel-group, Study of Two Dose Levels of XXX Compared to Placebo in the Adjunctive Treatment of Outpatients with Sub-Optimally Controlled Symptoms of Schizophrenia A Phase II, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of XXX for the Treatment of Schizophrenia to Mitigate or Prevent XXX -Induced Weight Gain A Phase III, Open Label, Multicenter, Extension of Study XXX to Assess the Long-term Safety and Durability of Effect of XXX in Subjects with Stable Schizophrenia A Phase III, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Low-dose XXX in Acutely Psychotic Subjects with Schizophrenia Phase III, Interventional, open-label, flexible-dose extension study of XXX in patients with schizophrenia Phase III, Interventional, randomized, double-blind, parallel-group, placebo-controlled, activereference, flexible-dose study of XXX in patients with acute schizophrenia A 12-week, Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of XXX in the Acute Treatment of Adults 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 Phase III Multicenter 40-Week Extension Study to Evaluate the Safety and Clinical Effects of Prolonged Exposure to 1 and 2 mg Doses of XXX as an Adjunctive Pro cognitive Treatment in Subjects with Schizophrenia on Chronic Stable Atypical Antipsychotic Therapy A Randomized, Double-blind, Placebo-controlled, Parallel, 12 Week, Phase III Study of 2 Doses of XXX or Placebo as an Adjunctive Pro-cognitive Treatment in Schizophrenia Subjects on Chronic Stable Atypical Antipsychotic Therapy - 7 -
A 12-week, Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of XXX in the Acute Treatment of Adults With Schizophrenia Other Indications A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Subcutaneously Administered XXX in Premenopausal Women with Hypoactive Sexual Desire Disorder (HSDD) (with or without Decreased Arousal) A Randomized Double-Blind, Placebo Controlled, Flexible Dose, Parallel Group Study of Extended-Release XXX for the Treatment of Generalized Anxiety Disorder (GAD) A Phase I, Open-Label, Pharmacokinetic Study to Evaluate the Steady-State Venous and Capillary Plasma Concentrations of Five Antipsychotics: XXX, XXX, XXX, XXX, and XXX A Phase II, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy, Safety, and Pharmacokinetic Behavior of Orally Administered XXX in Subjects with Drug- Induced Tardive Dyskinesia 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 II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate Efficacy and Safety of XXX in Combination with Selective Serotonin Receptor Inhibitors in Patients with Obsessive Compulsive Disorder LANGUAGES: Spanish & English Fluent - 8 -