LYNN WILLIAMS 2800 Hill Street New Smyrna Beach, Fl 32169 (321) 228-7541 EMAIL : [email protected]
Millenia Psychiatry & Research F/K/A Ali A. Kashfi, MD, PA
Orlando, Fl. 32829 October 2013 – Present (Clinical Research Director) Ali A. Kashfi, MD, PA
Orlando, Fl. 32829 June 2011 – October 2013 (Clinical Research Director) Ali A. Kashfi, MD, PA
Rating Scales: I have worked with the following rating scales; K-SADS, MINI, SCID, HAMD, MADRS, CGI-S/I, CDRS, CSSR-S, AIMS, BARS, PANSS, ADIR, ADOS, KBIT, YMRS, SRS, HADS, and many others. Data Entry Systems: I have worked with the following Data entry systems; INFORM, DATA LABS, RDC, MEDIDATA RAVE, and EDC PPDI RESEARCH EXPERIENCE:
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Flexible-Dose Study Evaluating Efficacy and Safety of Study Drug versus Placebo in Patients with Major Depressive Disorder, 2002. A Double-Blind, Placebo-Controlled, Parallel-Group, Flexible-Dose Study of Antidepressant in Adolescent Outpatients with Panic Disorder, 2002 A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Flexible-Dose Study Evaluating Efficacy and Safety of SB-659746-A in Patients with Major Depressive Disorder – 2002 Alzheimer Banking Genetic Study for Early Onset Alzheimer Disease – 2002 Alzheimer Banking Genetic Study for Late Onset Alzheimer Disease – 2002
RESEARCH TRIALS, CONTINUED A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Safety and Efficacy Trial of an Antidepressant in Outpatient Children and Adolescents with Major Depressive Disorder - 2002 A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy Trial of the Use of Quetiapine Fumerate (Seroquel) in the Treatment of Patients with Bipolar Depression, 2002 - 2003 A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy Trial of the Use of Quetiapine Fumarate (Seroquel) in the Treatment of Patients with Bipolar Depression, 2002-2003. Escitalopram Effects on Quality of Life, 2002-2003. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Safety and Efficacy Trial of Antidepressant in Outpatient Children and Adolescents with Major Depressive Disorder, 2003. A Multicenter, Double-Blind, Randomized, Placebo-Controlled Flexible Dose Study Evaluating Efficacy, Safety and Tolerability of Once Daily Oral Antidepressant in Patients with Major Depressive Disorder – 2003 A Multicenter Study for DNA/RNA/SERUM Banking in Subjects with Late Onset Alzheimer’s Disease, 2003. Open-Label Extension Trial in Children and Adolescents with Major Depressive Disorder Who Participated in One of the Short-Term Studies for Safety and Efficacy Trials, 2003-2004. A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Flexible-Dose Study Evaluating Efficacy, Safety, and Tolerability of Once-Daily Oral Antidepressant versus Placebo in Subjects with Major Depressive Disorder Over an Eight-Week Treatment Period, 2003-2004. Fixed Dose, Double-Blind, Placebo-Controlled Study Comparing Study Drug to Risperidone for the Assessment of Negative Symptoms in Patients with Schizophrenia or Schizoaffective Disorder, Depressive Type – 2004. A Randomized, Double-Blind, Placebo-Controlled, Flexible Dose Study Comparing Antidepressant and Venlafaxine ER in Adult Patients with Major Depressive Disorder, 2004. A Confirmatory, Multicenter, Double-Blind, Randomized, Placebo Controlled Trial in the Use of Antipsychotic in Treatment of Patients with Bipolar Depression, 2004. A Multicenter Study of F1J-MC-HMCX: Lilly’s Emotional And Physical Symptoms of Depression Study, 2004.
RESEARCH TRIALS, CONTINUED A 10-month Open Label Evaluation of the Long-Term Safety of Antidepressant in Outpatients with Major Depressive Disorder, 2004 - 2005. A Confirmatory Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Use of Quetiapine Fumarate (Seroquel) in the Treatment of Patients with Bipolar Depression, 2004 - 2005. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Flexible-Dose Study of Antidepressant and Venlafaxine ER in Adult Patients with Major Depressive Disorder, 2004 - 2005. A 10-Month Open-Label Evaluation of the Long-Term Safety of Antidepressant in Outpatients with Major Depressive Disorder, 2004 - 2006. A Multicenter, Randomized, Parallel-Group, Double-blind, Phase III Comparison of the Efficacy and Safety of Quetiapine Fumarate to Placebo When Used as Adjunct to Mood Stabilizers in the Maintenance Treatment of Bipolar I Disorder in Adult Patients, 2005 - 2006. An International, Multicenter, Double-Blind, Randomized, Parallel-group, Placebo-Controlled, Phase III Study of the Efficacy and Safety of Quetiapine Fumarate (Seroquel) and Paroxetine as Monotherapy in Adult Patients with Bipolar Depression for 8 weeks and Quetiapine in Continuation Treatment for 25-52 weeks, 2005 - 2007. An Extension Study of the Safety and Efficacy of Lexapro in Pediatric Patients with Major Depressive Disorder, 2006 - 2008 A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Sustained-Release Quetiapine Fumerate (Seroquel) Compared with Placebo in the Treatment of Generalized Anxiety Disorder, 2006 - 2007 A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumerate (Seroquel) as Monotherapy in the Treatment of Patients with Major Depressive Disorder, 2006 - 2007 A Multicenter, Double-Blind, Parallel Group, Fixed Dose, 4-arm, Placebo and Paroxetine-Controlled 8-Week Efficacy Study in Adult Outpatients with Major Depressive Disorder, 2006 - 2007 A Double-Blind Flexible Dose Study of Lexapro in Pediatric Patients with Major Depressive Disorder, 2006 - 2007. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Followed by an Open-Label Extension to Evaluate the Efficacy and Safety of DVS-SR in Peri and Postmenopausal Women with Major Depressive Disorder, 2007 - 2008
RESEARCH TRIALS, CONTINUED An 8-week, Multicenter, Randomized, Double-Blind, Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine 25 or 50 mg given once daily in the treatment of Major Depressive Disorder (MDD) followed by a 52-week Open-Label Treatment with Antidepressant 25mg or 50mg, 2007 - A Phase IV, Double-Blind, Placebo-Controlled, Randomized, Flexible-Dose Study of the Safety and Efficacy of an Antidepressant in Adolescents with Major Depression, 2007 – A Multicenter 12-week, Randomized, Open-Label Trial of Duloxetine Versus Generic SSRIs in the Treatment of a Severe Depressive Episode, 2008 - A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Referenced, Fixed-Dose Study Comparing the Efficacy and Safety of 3 Doses of Anti-anxiety Medication in Acute Treatment of Adults with Generalized Anxiety Disorder, 2008 - A Multicenter Study for The Evaluation of an Anticonvulsant as an Add-on Treatment for Bipolar I Disorder in children and Adolescents, 10 to 17 Years of Age, 2008 -
A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Study Medication in subjects with Major Depressive Disorder, 2009 - A Double-Blind, efficacy and Safety Study of Antidepressant versus Placebo in the Treatment of Children and Adolescents with Major Depressive Disorder, 2009 - A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of XXXX as Maintenance Treatment in Patients with Schizophrenia 2009 A 52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of XXXX Intramuscular Depot Formulation as Maintenance Treatment in Patients with Schizophrenia 2009 A Double-Blind, Efficacy and Safety Study of XXXX versus Placebo in the Treatment of Children and Adolescents with Major Depressive Disorder 2009 A 12-week, randomized, double-blind, placebo-controlled, Phase III safety trial of XXXX in women taking a Selective Serotonin or Serotonin-Norepinephrine Reuptake Inhibitor with decreased sexual desire and distress 2010 An 8-week, randomized, double-blind, placebo-controlled, parallel-group, multi-center study of the efficacy and safety of agomelatine 0.5 mg and 1 mg sublingual tablets administered once daily in patients with Major Depressive Disorder (MDD) 2010 A 52-week, multi-center, open-label study of the safety and tolerability of agomelatine sublingual tablets in patients with Major Depressive Disorder (MDD) 2010
RESEARCH TRIALS, CONTINUED Evaluation of Growth, Sexual Maturation, and Prolactin-Related Adverse Events in the Pediatric Population Exposed to Atypical Antipsychotic Drugs 2010
A Randomized Placebo-Controlled, Double-Blind Study of XXX Flexible Dose 12 to 18 mg Once Daily as Adjunctive Treatment for Patients with Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor Treatment 2011
An 8-week, placebo-controlled, double-blind, randomized, fixed-dose efficacy and safety trial of XXX in adolescent subjects with schizophrenia 2011
A 26-week, multi-center, open-label, flexible dose, long-term safety trial of XXX in adolescent subjects with schizophrenia 2011 The Evaluation of XXXX as an Add-on Treatment for Bipolar I Disorder in Children and Adolescents, 10 to 17 Years of Age 2011
Efficacy and Safety of 3-Week Fixed-Dose Asenapine Treatment in Pediatric Acute Manic or Mixed Episodes Associated with Bipolar I Disorder 2011
A 50-Week Open-Label, Flexible-Dose Trial of Asenapine Extension Treatment to P06107 in Pediatric Acute Manic or Mixed Episodes Associated With Bipolar I Disorder 2011 A Randomized Placebo-Controlled, Double-Blind Study of LY2216684 Flexible-Dose 12 to 18 mg Once Daily as Adjunctive Treatment for Patients with Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor Treatment 2011
A Multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety and tolerability of XXXX XXXX sustained-release (DVS SR) in the treatment of children and adolescent outpatients with Major Depressive Disorder 2012
A 6 Month, open label, multi center, flexible dose extension study to the extention study to the XXXXX study to evaluate the safety, tolerability and efficacy XXXXX XXXXXX sustained release (DVS SR) tablets in the treatment of Children and Adolescent outpatients with Major Depressive Disorder 2012
RESEARCH TRIALS, CONTINUED A Phase 2, Multicenter, Double-blind, Parallel-group, Randomized, Placebo-controlled, Forced-dose Titration, Dose-ranging Efficacy and Safety Study of XXXX in Combination with an Antidepressant in the Treatment of Adults with Major Depressive Disorder with Inadequate Response to Prospective Treatment with an Antidepressant. 2012 A Phase 3, Open-label, Multicenter, 12-month Extension Safety and Tolerability Study of XXXX 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 2012 An Open-Label Study of The Safety And Tolerability Of XXXXX In Pediatric Patients With Autism, Asperger's Disorder, Or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) 2012 A Double-Blind Placebo-Controlled, Randomized Withdrawal Study of The Safety And Efficacy Of XXXXXX In Pediatric Patients With Autism, Asperger's Disorder, Or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Previously Treated With XXXXXX 2012 An Open-Label Extension Study of The Safety And Tolerability Of XXXX In Pediatric Patients With Autism, Asperger's Disorder Or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) 2012 Interventional, randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study to evaluate the efficacy and safety of XXXXXXX (1 and 3 mg/day) as adjunctive treatment in elderly patients with major depressive disorder with an inadequate response to antidepressant treatment 2013 (NOTE: Some trade names of medication withheld pursuant to sponsor agreements) Update 10/1/13
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