Clinical Trials

Siyan Clinical Research

Siyan Clinical Research (SCR) is a scientific research organization where pharmacological studies are conducted in an outpatient environment. Our specialty is in psychiatric care, treating patients with diagnoses’ including depression, anxiety, panic disorder, obsessive compulsive disorder, post-traumatic stress disorder, ADD/ADHD, bi-polar disorder, phobias, and cognitive disorders.

SCR is the largest psychiatric facility in northwestern California, serving over 3,500 patients across 6 counties. We have a diverse adult patient population and are currently accepting new patients. SCR is located in Santa Rosa, California and provides treatment to patients living in Sonoma, Lake, Mendocino, Napa, Solano and Marin Counties.

Referrals to the SCC’s newly renovated home office in Santa Rosa, California are made by private medical and mental health professionals along with agencies, facilities, family members and the patients themselves.

Research participants may receive mental health services free of charge, dependent the type of clinical trial and corresponding sponsorship. SCC also accepts most commercial insurance plans including: Anthem Blue Cross, Blue Shield of CA, Cigna, Aetna, MHN, HealthNet, Magellan, and Medicare with a supplement.

To improve quality of life for patients suffering from mental disorders in northwest California.

To promote quality of care for mental health patients through individualized treatment and patient education by a highly qualified, experienced and compassionate team.

To provide access to care for low-income patients by offering discounted or free treatment through our research initiatives.

To advance knowledge of pharmaceutical medicine in the treatment of psychiatric disorders by conducting quality, science-based research studies dedicated to improving the well-being of our patients.

SCR’s facility is located in the center of an active medical community in Santa Rosa, CA. We are located approximately 8 miles from the Charles M. Schulz – Sonoma County Airport (STS) and 2 hours from the Sacramento International Airport with many major hotels and restaurants available close to the study site. Public transportation includes a nearby bus stop serving the greater Sonoma County area.

The Siyan clinic is specially-designed and equipped to conduct outpatient studies on site. SCR is able to carry out a full range of assessments and tests. Other in-house services include:

  • Pharmacy (double locked, security alarms, cold drug storage)
  • Laboratory
  • Refrigerator for specimens
  • Phlebotomy
  • Medical Records department and storage (locked, security alarms)
  • Long term records storage (JCAHO accredited, alarmed dedicated space, controlled access)
  • Locked drug storage room with motion sensors
  • Temperature-controlled, double-locked investigational drug storage
  • Facility security system with motion sensors and overhead sprinkler system
  • Exam room
  • Electrocardiogram (ECG)
  • Transcranial Magnetic Stimulation (TMS) technology
  • 24-hour emergency phone number
  • Dry Ice on site
  • Large, private lockable conference room dedicated to monitors with internet access and telephones
  • High-speed internet access: wired or wireless
  • Daily FedEx, UPS, and USPS pickup
  • Dedicated fax and copy machines
  • Lounge area with large screen TV, refrigerator, refreshments, microwave and coffee machine

We use Central IRB for our research.

Principal Investigator: Anish Shah, M.D.
Areas of Interest: CNS/Neurological Research

Dr. Shah is the founder and director of Siyan Clinical Corporation located in Santa Rosa, CA. He also serves as consultant for 15 primary care practices in Sonoma County, CA. Dr. Shah is certified by the American Board of Psychiatry and Neurology since 2003 and completed his residency at the University of Illinois in Chicago, Illinois. Since residency, he gained extensive experience as a General Psychiatrist for Lake County Mental Health, Kaiser Permanente and Sonoma County Mental Health. In addition to direct patient care, Dr. Shah also served as Medical Director of Napa State Hospital before launching his own practice in 2012. As the Medical Director at Napa State Hospital, Dr. Shah led a staff of 220 medical professionals and managed a $4 million medical services budget.

Research experience

Principal Investigator: A 10-Week, Open-Label, Flexible Dose Adaptive Study Evaluating the Efficacy of Vortioxetine in Subjects with Panic Disorder. Initiated research study, protocol writing and submissions, conducted Informed Consent Process, Medical History, DSM-IV, MINI, C-SSRS, MOSES, Concomitant Medication, and Adverse Event Assessments. Study drug dispensing, titration, and accountability assessments. Involved in recruitment activities and provides training support and oversight to other study personnel.

Research Assistant: Participated in research activity with Dr. David Marazek and Dr. Karen Weihs information such as involvement making lay protocol summary, conduct literature search, website development, videotaping sessions, and other usual and customary tasks of research assistant. Participated in studies involving drugs such as Paroxetine Divalproex Sodium.

Research Assistant: Participated in research study with Philip Janicak as a second year and fourth year resident on Transcranial Magnetic Stimulation vs. ECT trial. The tasks involved clinical assessment, screening, monitoring, and treatment of study participants, tracking patient participation, and other coordination functions of clinical trials.

Research Assistant: Worked with Dr. Daniel Liberman on preparation for his research on “Internet Interactive Social Skill Training and Intervention for Alcohol Abuse College Students”.
GCP certified.

Sub-Investigator: Jeannie LeMesurier, PhD.
Areas of Interest: CNS/Neurological Research

Jeannie LeMesurier, PhD. is a clinical psychologist, life coach and motivational speaker. She has over 30 years’ experience working with both children and adults providing diagnostic evaluations, psychological and educational assessments, psychotherapy and interventions. Dr. LeMesurier has served in the capacity of clinical psychologist, professor, counselor and advisor. She is fluent in both English and French and speaks functional Spanish.

Dr. LeMesurier received her undergraduate and graduate degrees from McGill University in Montreal, Canada and her doctoral degree from Université de Montréal in Québec, Canada. Her Ph.D. is from l’Université de Montréal and served her Post-Doctoral Fellowship at the Reiss Davis Child Study Center in Los Angeles, California, specializing in child psychoanalytic psychotherapy. Dr. LeMesurier is a California state licensed clinical psychologist and practices solution-focused psychotherapy, Cognitive Behavior Therapy, Mindfulness, Positive Psychology, and coaching to help people with depression, anxiety, ADD/ADHD, stress, and more.

Sub-Investigator: Dr.Naga Kothapalli, PhD.
Areas of Interest: CNS/Neurological Research

Dr. Kothapalli completed medical school in India where he worked in primary care and emergency medicine prior to moving to the U.S. in 2010. He has broad research experience in psychiatry and chemical dependency from the University of Texas Health Sciences at Houston, and Baylor College of Medicine. Dr. Kothapalli moved to New York and finished his psychiatric externships at Long Island Jewish Hospital in Queens, St. Luke Roosevelt Hospital in Manhattan, and Brooklyn Developmental Center in Brooklyn. He finished his residency training in Adult Psychiatry at St. Mary Mercy Hospital in Michigan where he further honed his skills. With this extensive back ground and training, Dr. Kothapalli joined our corporation as a full-time attending psychiatrist. He is passionate about providing excellent evidence-based, patient centered care in a very supportive and thoroughly professional manner.

Clinical Coordinator: Katherine M. Hauch
Areas of Interest: CNS/Neurological Research

As study coordinator for SCR, Katherine’s role is to assist in the coordination and management of clinical research for each study as required per protocol. Under the principal investigator’s supervision, Katherine helped launch SCC into the research arena by assisting in the development and execution of their first clinical trial, an investigator initiated protocol. She worked with a team to create and edit all source documents and budgets along with the study protocol. Katherine was responsible for recruitment and screening, participant orientation, dispensation of the investigational product, and collection of vital signs. She was the main point of contact with the IRB, FDA and the sponsor, ensuring timely submission of required documentation, including the reporting of any suspected SAE’s.

Katherine has worked in the healthcare industry since 2003 and has over 10 years of records management, medical billing, and front office management experience. She initially started out as an office manager for SCR in early 2012 and in January 2015 was promoted to a study coordinator. Katherine is GCP certified and has successfully coordinated and assisted in an investigator initiated, 10-week clinical study evaluating the efficacy of Vortioxetine in subjects with panic disorder.

clinical research study coordinator: Vivian Dao, M.S.
Areas of Interest: CNS/Neurological Research

Vivian Dao, M.S., is the clinical research study coordinator at Siyan Clinical Research. She manages the clinical trial studies as required per protocol and regulatory affairs associated with the Institutional Review Board (IRB), National Institutes of Health (NIH), and other funding agency reports. She also ensures compliance with state and federal regulatory guidelines for the collection of clinical data by acting as the principal administrative liaison to pharmaceutical industries. Her duties include coordinating research team meetings, scheduling patient’s visit dates, dispensation and consultation of the investigational product. She strives to preserve the integrity of human research by protecting each patient’s confidentiality and accurately reports data tracking information about the study’s objectives.

Vivian received her B.S. degree in Biological Sciences from Sacramento State University and recently obtained her M.S. degree in Medical Health Sciences at Touro University California. Before coming to Siyan Clinical Research, Vivian conducted health outcomes research projects which included investigating the correlation of drugs/diseases with impairments associated with driving performance.

As a clinical researcher, Vivian aims to improve health outcomes by providing accurate data from clinical trials to health professionals, scientists, and pharmaceutical industries. Vivian also advocates for her community while collaborating with health care providers and scientists to discover new therapies to prevent disease/symptom progression. Most importantly, Vivian enjoys educating patients about available resources that can help them improve their quality of life.

The clinical staff at SCR work together to provide the highest quality psychiatric care in an atmosphere of respect, compassion, and a belief in the innate value of every individual. Working closely with our principal investigator, we have five Nurse Practitioners with an average experience level of more than 5 years. Our two senior clinical psychologists, Jeannie LeMesurier, Ph.D. and Warren S. Bean, Ph.D., have over forty years of combined experience in providing psychiatric care to patients.

SCR values communication, timeliness, efficiency and quality in the clinical trial process. We are committed to conducting trials in accordance with the protocol of the sponsor, CRO and FDA. We strive to continually improve our research skills and encourage feedback.

SCR is a newly dedicated research site, involved in clinical research since the 2015. For the past few years, we have been direct patient care only and have grown into a thriving practice with a large patient database. Our interest is research in phases II, III, and IV. We have worked previously with Takeda Pharmaceuticals Inc.

Our team of providers have years of experience treating patients with diagnosis’ including depression, anxiety, panic disorder, obsessive compulsive disorder, post-traumatic stress disorder, ADD/ADHD, bi-polar disorder, phobias, and cognitive disorders.

Our staff is well-versed in the following rating scales:

ADHD

 

  • Adult ADHD Self-Report Scale
  • Brown Attention-Deficit Disorder Scales
  • Swanson, Nolan and Pelham Teacher and Parent Rating Scale
  • Vanderbilt ADHD Diagnostic Rating Scale
  • ADHD Rating Scale
  • Autism spectrum

Adult Asperger Assessment

  • Australian scale for Asperger’s syndrome (ASAS)
  • Autism Spectrum Quotient (AQ)
  • Childhood Autism Rating Scale
  • Childhood Autism Spectrum Test
  • Quantitative Checklist for Autism in Toddlers (Q-CHAT)
  • Autism Diagnostic Observation Schedule

Mania and bipolar disorder

  • Altman Self-Rating Mania Scale (ASRM)
  • Young Mania Rating Scale (YMRS)

Dissociation

 

  • Dissociative Experiences Scale (DES)
  • Structured Clinical Interview for DSM-IV Dissociative Disorders (SCID-D-R)

Depression

 

  • Beck Depression Inventory (BDI)
  • Beck Hopelessness Scale
  • Centre for Epidemiological Studies – Depression Scale (CES-D)
  • Center for Epidemiological Studies Depression Scale for Children (CES-DC)
  • Edinburgh Postnatal Depression Scale (EPDS)
  • Geriatric Depression Scale (GDS)
  • Hamilton Rating Scale for Depression (HAM-D)
  • Hospital Anxiety and Depression Scale
  • Kutcher Adolescent Depression Scale (KADS)
  • Major Depression Inventory (MDI)
  • Montgomery-Åsberg Depression Rating Scale (MADRS)
  • Mood and Feelings Questionnaire (MFQ)
  • Zung Self-Rating Depression Scale

Schizophrenia and psychosis

  • Brief Psychiatric Rating Scale (BPRS)
  • Positive and Negative Syndrome Scale (PANSS)
  • Scale for the Assessment of Positive Symptoms (SAPS)
  • Scale for the Assessment of Negative Symptoms (SANS)

Anxiety

 

  • Beck Anxiety Inventory
  • Clinician Administered PTSD Scale (CAPS)
  • Daily Assessment of Symptoms – Anxiety
  • Generalized Anxiety Disorder 7 (GAD-7)
  • Hamilton Anxiety Scale (HAM-A)
  • Hospital Anxiety and Depression Scale
  • Panic and Agoraphobia Scale (PAS)
  • Panic Disorder Severity Scale (PDSS)
  • PTSD Symptom Scale – Self-Report Version
  • Social Phobia Inventory (SPIN)
  • Trauma Screening Questionnaire
  • Yale–Brown Obsessive Compulsive Scale (Y-BOCS)
  • Zung Self-Rating Anxiety Scale

Personality and personality disorders

  • Buss-Perry Aggression Questionnaire (AGQ)
  • Hare Psychopathy Checklist
  • Minnesota Multiphasic Personality Inventory
  • Narcissistic Personality Inventory

Dementia and cognitive impairment

  • Abbreviated mental test score
  • Clinical Dementia Rating
  • General Practitioner Assessment Of Cognition
  • Informant Questionnaire on Cognitive Decline in the Elderly
  • Mini-mental state examination

Eating disorders

  • Anorectic Behavior Observation Scale
  • Binge Eating Scale (BES)
  • Eating Attitudes Test (EAT-26)
  • Eating Disorder Inventory (EDI)

Global scales

  • Clinical Global Impression
  • Comprehensive Psychopathological Rating Scale (CPRS)
  • Global Assessment of Functioning (GAF)
  • Children’s Global Assessment Scale

Other

  • Barnes Akathisia Scale
  • CAGE Questionnaire
  • SAD PERSONS scale for suicide risk

Since inception in 2012, SCR has developed rapidly, now serving over 3,500 adult patients and growing. In 2014, we averaged 58 new patients/month, in 2015 we averaged 61 new patients/month and in 2016 we have averaged 63 new patients/month. Here is a current breakdown of our patient database by diagnosis category:

Diagnosis Groups Percentage of
Patient Population
Anxiety 45%
Depression 37%
Bipolar 20%
Attention Deficit 9%
Panic 7%
PTSD 2%
Compulsive 2%
Unspecified Psychosis 0.7%
  • Anxiety
  • Depression
  • Bipolar
  • Attention Deficit
  • Panic
  • PTSD
  • Compulsive
  • Unspecified Psychosis

Our facility caters to patients living in the 6 surrounding counties including:

Sonoma, Lake, Mendocino, Napa, Solano and Marin Counties.
Here is a quick overview of demographics broken down by area:

County Population %Caucasian %African
American
%American
Indian/Alaska
Native
%Asian %Hispanic
or Latino
Sonoma 502,146 87.3% 2.0% 2.2% 4.4% 26.3%
Solano 436,092 60.4% 14.8% 1.3% 15.7% 26.0%
Napa 142,456 84.5% 2.4% 1.2% 8.3% 32.2%
Marin 261,221 85.8% 2.9% 1.0% 6.2% 16.0%
Mendocino 87,649 86.3% 1.0% 4.9% 2.2% 24.5%
Lake 64,591 87.6% 2.1% 4.1% 1.4% 19.6%
Source: www.census.gov (2016)

As of October 2016, our area has been designated as a Health Provider Shortage Area (HPSA) by the Health Resources and Services Administration (HRSA), a subsect of the U.S. Department of Health and Human Services. This recently acquired HPSA designation will indirectly allow us access to even more patients, as incentives to bring more providers into the area will increase along with the patient load.

SCR is an active member of the local mental health provider network, working with many different county-sponsored health centers along with varied private practice physicians. We have a portion of our website dedicated to recruitment and manage the recruitment and screening process in-house.

Are you interested in enrolling in a clinical trial? Please fill out the below information form including your area of interest.

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