CONTACT INFORMATION: Site Selection and Information: Bobbie Theodore, Site Liaison Tel. (916) 939-6696 Fax (208) 575-3169 Email: clinicaltrials@alliancesites.com EDUCATION: Jennifer M. Lytle, M.D., M.P.H. Clinical Trials of the Rockies 3955 E. Exposition Avenue, Suite 100 Denver, CO 80209 Tel. 303-437-8312 1997-2001 Doctor of Medicine Northwestern University Medical School, Chicago, IL 1997-2001 Masters in Public Health Focus in Epidemiology/ Biostatistics Northwestern University, Chicago, IL 1992-1996 Bachelor of Arts Pomona College, Claremont, CA INTERNSHIP, FELLOWSHIP, and RESIDENCY: 2001-2005 Psychiatry Residency Inpatient and Outpatient training with children and adolescents Outpatient Psychopharmacology Chief Resident Harvard Longwood Psychiatry Residency Training Program, Boston, MA 2003-2005 American Psychiatric Association (APA) Fellowship in Public Sector Psychiatry APA Council on Quality Care APA Resident Representative to the Joint Reference Committee CERTIFICATIONS & LICENCES: Heartsaver, CPR Colorado Medical License #43293 American Board of Psychiatry and Neurology 2008- Present 2005- Present 2005- Present 1
INVESTIGATOR EXPERIENCE: Addictions Alzheimer's Disease Anxiety Bipolar Disorder Depression Eating Disorders Hypertriglyceridemia Schizophrenia and Schizoaffective Disorder Sexual Disorder PROFESSIONAL EXPERIENCE: Principal Investigator, 2015 - present Clinical Trials of the Rockies Weiss and Lytle, PLLC Partnering with Mountain View Clinical Research, Inc., Denver, CO Co-investigator David Weiss, M.D. Adult Outpatient Private Practice, 2015-Present Jennifer Lytle, LLC., Denver, CO Medical Director/ Clinical Trials Investigator, 2008-2015 Western Affiliated Research Institute, Denver, CO Co-investigator David Weiss, M.D. Consultant and Speaker, 2008-2011 Pfizer, regarding antipsychotic Geodon Based in Denver, CO and included lecturing in 5+ states Staff Psychiatrist, 2005-2010 Wellness Committee physician representative Nominated by patient and staff committee for Recovery Champion Award Intensive Outpatient Office, Jefferson Center for Mental Health, Lakewood, CO Principal Investigator, 2006-2008 Front Range Clinical Research, Wheat Ridge, CO Research Associate, 1996 Epidemiology Branch, data management for government sponsored studies SRA Technologies, Inc., Falls Church, MD CLINICAL TRIAL EXPERIENCE: Addictions Induction, Stabilization, Adherence and Retention Trial (ISTART): A randomized noninferiority multicenter study to assess early treatment efficacy of XXX versus XXX and to explore switching between treatment 2
A Phase IV, Non-Treatment Follow-up for Cardiac Assessments Following Use of Smoking Cessation Treatments 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 of XXX and XXX for Smoking Cessation in Subjects with and without a History of Psychiatric Disorders 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 Health-Related Quality-of-Life and Health-Care Resource Utilization Assessment in XXX and XXX (Smoking Cessation) Phase III Studies A Second Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess XXX as an Aid to Smoking Cessation Alzheimer's Disease A Phase III, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety and Tolerability of Flexible Dosing of XXX in the Treatment of Subjects with Agitation Associated with Dementia of the Alzheimer's Type Anxiety An 8-week, Randomized, Phase II, Double-blind Sequential Parallel-Group Comparison Study of Two Dose Levels of XXX Compared to Placebo as an Adjunctive Treatment in Outpatients with Inadequate Response to Standard of Care for Generalized Anxiety Disorder A Multicenter, Randomized, Double-Blind, Placebo and Escitalopram Controlled Trial of the Safety and Efficacy of XXX in the Treatment of Outpatients with Generalized Anxiety Disorder Bipolar Disorder A Randomized, Double-blind, Placebo-Controlled, Proof-of-Concept, Phase II Study to Evaluate the Efficacy and Safety of XXX in the Treatment of Acute Depressive Episodes Associated with Bipolar I Disorder in Adult Patients who are on XXX A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept, Phase II Study to Evaluate the Safety of XXX as an Adjunctive Therapy to Treatment-as-Usual in the Maintenance Treatment of Bipolar I Disorder in Adults 3
A Randomized, 9-Week, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed and Flexible Doses of XXX in Adults with Bipolar Depression Depression 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 III, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Fixed-dose XXX as Adjunctive Therapy in the Treatment of Adults with Major Depressive Disorder With and Without Anxious Distress Interventional, Open-Label, Flexible-Dose, Exploratory Study of XXX as Adjunctive Treatment of Irritability in Patients with Major Depressive Disorder and an Inadequate Response to Antidepressant Therapy Interventional, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose, Study to Evaluate the Efficacy and Safety of XXX as Adjunctive Treatment in Elderly Patients with Major Depressive Disorder with an Inadequate Response to Antidepressant Treatment 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 II, Multicenter, Double-blind, Parallel-group, Randomized, Placebo-controlled, Forceddose Titration, Dose-ranging Efficacy and Safety Study of XXX in Combination with XXX in the Treatment of Adults with Major Depressive Disorder with Inadequate Response to Prospective Treatment with an Antidepressant A Phase III, Open-label, Multicenter, 12-month Extension Safety and Tolerability Study of XXX in Combination with XXX in the Treatment of Adults with Major Depressive Disorder with Residual Symptoms or Inadequate Response Following Treatment with an Antidepressant A Multicenter, Randomized, Double-Blind, Active-Controlled, Comparative, Fixed-Dose, Dose Response Study of the Efficacy and Safety of XXX in Patient with Treatment Resistant Depressant A Multicenter, Double-Blind, 58 Week Rollover Study to Assess the Safety and Tolerability of XXX in Patients with Treatment Resistant Major Depression 4
A Multicenter, Randomized, Double-Blind, Placebo controlled, Phase III, Long-Term Safety and Tolerability Study of XXX as an Adjunct to XXX in Patients with Major Depressive Disorder Who Exhibit an Inadequate response to Antidepressant Therapy A Multicenter, Randomized, Double-Blind, Placebo controlled, Phase III, Efficacy and Safety Study of XXX as an Adjunct to XXX in Patients with Major Depressive Disorder A Multicenter, Parallel-Group, Randomized, 10 week, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of XXX in the Treatment of Peri-and Postmenopausal Women with Major Depressive Disorder An 8-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study of the Efficacy and Safety of XXX in Patients with Major Depressive Disorder A Randomized, Double-Blind, Parallel Group Study to Compare Discontinuation Symptoms in Abrupt Discontinuation Versus a 1-Week Tapering Regimen in Subjects with Major Depressive Disorder Treatment for XXX A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of XXX in Adults Outpatients with Major Depressive Disorder A Double-Blind, Placebo-Controlled, Flexible-Dose Study of XXX in Patients with Major Depressive Disorder A Long-Term, Open-Label Extension Study of XXX in Adult Patients with Major Depressive Disorder An Open-Label Study to Evaluate the Prevalence of Phenotypic Poor Metabolizers at CYP2D6 Among XXX-Treated Outpatients with Depression A Double-Blind, Randomized, Placebo-Controlled Study Examining the Safety, Efficacy, and Tolerability of XXX in Subjects with Major Depressive Disorder (including Atypical and Melancholic Features) A 52-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Long- Term Efficacy, Tolerability and Safety of XXX in the Prevention of Relapse of Major Depressive Disorder (MDD) Following Open-Label Treatment over 16-26 Weeks A Multicenter, Randomized, Double-Blind, Placebo and Escitalopram Controlled Trial of the Safety and Efficacy of XXX in the Treatment of Outpatients with Major Depressive Disorder 5
Eating Disorders The XXX 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 Other Indications Establishment of Normative Data of XXX Using Evoked Response Potentials in Adolescents, Young Adults, and Adults A Long-Term Outcomes Study to Assess Statin Residual Risk Reduction with XXX in High Cardiovascular Risk Patients with Hypertriglyceridemia A 12-week Randomized, Double-Blind, Placebo-Controlled, Phase III Safety Trial of XXX in Women with Decreased Sexual Desire and Distress "Computerized HIV Risk Assessment: A Software Validation Study" and "HIV Risk Assessment Software Validation Study and the Effects of AIDS Prevention Messages on College Women." Conducted at Pomona College "Infant Experience and Late-Childhood Dispositions: An Eleven-Year Follow-up Among the Logoli of Kenya." Conducted at Pitzer College Schizophrenia and Schizoaffective Disorders A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of XXX in Acutely Psychotic Subjects with Schizophrenia A 12-week, Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of XXX Intramuscular Depot in the Acute Treatment of Adults with Schizophrenia A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of XXX Evaluating Time to Relapse in Subjects with Schizoaffective Disorder A Randomized, 6-Week, Open-Label, Study Evaluating Safety, Tolerability, and Efficacy of XXX, for the Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched from other Antipsychotics 6
A 24 week, Flexible-Dose, Open-Label Extension Study of Subjects Switched to XXX for the Treatment of Schizophrenia or Schizoaffective Disorder The Efficacy of XXX as Compared with two Antipsychotics for Patients with Schizophrenia AWARDS: Harvard Medical School, Excellence in Student Education Award 2003 Pomona College Anthropology Prize for outstanding research 1996 SPEAKING EXPERIENCE: 2014 "Treating Mood Disorders: Thoughts and Practices" presented at The Institute at Maria Droste Counseling Center, Denver, CO 2010 Interviewed on ABC News Colorado about smoking cessation trials 2008-2011 Speakers Bureau for Pfizer Pharmaceuticals, New Mexico, Texas, Kansas, and Colorado 2007-2009 Jefferson Center for Mental Health Wellness Committee lectures to staff and patients about side effect management, preventing metabolic syndrome, neuroanatomy, and innovations in psychopharmacoloy, Lakewood, CO 2005 Harvard Grand Rounds borderline personality disorder case presentation to over 100 psychiatry professors and students, Boston, MA 2004 "Do More People Get Mental Health Care on the Internet than in the Office?" presented at the American Psychiatric Association Institute on Psychiatric Services, October 7, 2004 Boston, MA. Featured in Psychiatric News 2000-2001 "The Development and Assessment of a Hepatitis B Education and Immunization Program for High School Students." Northwestern University Medical School Masters of Public Health research project/thesis, Chicago, IL 2000 "Psychological Aspects of Hyperemesis Gravidarum," Consultation/Liaison Psychiatry Department, Northwestern Memorial Hospital, Chicago, IL 7
SPEAKING EXPERIENCE (continued): 1998 "Alternative Medicine," Trilogy, Inc., outpatient psychiatric treatment center, Chicago, IL 1994-1996 Developed and presented AIDS education programs to college students and pregnant teens through The Foothill AIDS Project Volunteer Speaker's Bureau, Claremont, CA PUBLICATIONS: Rosenberg J. Salzman C. Untitled [letter]. CNS Spectrums 2008; 13:110. Rosenberg J, Salzman C. Update: New Uses for Lithium and Anticonvulsants. CNS Spectrums 2007;12:831-41. Salzman C, Rosenberg J, Feldman. Schizophrenia Symptoms Remain Stable While Decreasing from Two Antipsychotics to Aripiprazole [letter]. Journal of Clinical Psychiatry 2007;68:970. Munroe R, Munroe L, Westling E, Rosenberg J. Infant Experience and Late-Childhood Dispositions: An Eleven-Year Follow-up Among the Logoli of Kenya. ETHOS: Journal for the Society for Psychological Anthropology 1997; 25:359-372. 8