Psychiatry Research Institute Montefiore-Einstein (PRIME)
The Autism and Obsessive Compulsive Spectrum Program at the Albert Einstein College of Medicine and Montefiore Medical Center is dedicated to three broad goals:
Developing innovative, novel and breakthrough treatments for a unique group of overlapping conditions.
Clarifying neurobiological mechanisms that underlie core symptom domains across these conditions.
Providing world-class care to our research participants.
Our Autism and Obsessive Compulsive Spectrum Program currently focuses on Autism Spectrum Disorders (ASD) and Prader-Willi Syndrome (PWS). Obsessive Compulsive Spectrum Disorders such as Obsessive Compulsive Disorder (OCD), Body Dysmorphic Disorder (BDD), Intermittent Explosive Disorder (IED) and Tourette Syndrome (TS) is also of interest to the program.
The Autism and Obsessive Compulsive Spectrum Program is located at the Psychiatry Research Institute at Montefiore Einstein (PRIME) in the Van Etten Building of the Albert Einstein College of Medicine.
Dr. Eric Hollander has been the PI of 10 federal grants, authored 560 publications, has 27,230 citations and an h-index of 92. He is Director of the International College of Obsessive Compulsive and Spectrum Disorders (ICOCS), and the Clinical TMS Society. He was chair of the DSM-5 Research Planning Agenda for Obsessive Compulsive and Related Disorders. He was director and PI of the NIH STAART Autism Center of Excellence, and PI of the NIMH Psychopharmacology Training Fellowship.
Dr. Hollander’s program has received funding from the Department of Defense, and the Orphan Products Division of FDA, for Autism, and Prader Willi Syndrome respectively. The program has developed targeted treatments for the repetitive behavior domain and the social communication domain of Autism Spectrum Disorder.
The program actively collaborates with the Einstein-Montefiore Institute for Clinical and Translational Research (ICTR) and other clinical investigators at Montefiore/Einstein.
The program has been awarded grant funding from the following organizations:
Department of Defense Autism Research Program
The Orphan Products Division of the Food and Drug Administration
Eunice Kennedy Shriver National Institute of Child Health and Human Development, part of the National Institutes of Health
Foundation for Prader-Willi Research
Simons Foundation Autism Research Initiative (SFARI).
Our program has worked with the following industry sponsors:
GW Pharmaceuticals
Sunovion Pharmaceuticals
F. Hoffmann-La Roche Ltd
Curemark LLC
Takeda
Avanir Pharmaceuticals
Neurocrine Biosciences
Pfizer
Forest Research Institute (now Allergan)
Transcept Pharmaceuticals
Coronado Biosciences
Autism and Obsessive Compulsive Spectrum Program Psychiatry Research Institute Montefiore-Einstein (PRIME) 1225 Morris Park Ave, Bronx, NY 10461 [email protected]
Eric Hollander M.D., Program Director/Principal Investigator
Bonnie Taylor Ph.D., Psychologist (718) 839-7530
Nilifa Desilva, Regulatory Coordinator (718) 839-7508
Vera Nezgovorova, Research Fellow (718) 839-7510
Yin Zhao M.D., Study Doctor and Research Fellow (718) 839-7514
Tarini Vats, Clinical Coordinator and Research Fellow (718) 839-7542
Casara Jean Ferretti, Pre-doctoral Research Associate 914-315-4236
Current Studies
Cannabidivarin (CBDV) vs. Placebo in Children with Autism Spectrum Disorder (ASD)
Intranasal Oxytocin vs. Placebo in Children with Prader-Willi Syndrome (PWS)
Cannabidivarin (CBDV) vs. Placebo in Children and Adults up to age 30 with Prader-Willi Syndrome (PWS).
Long-term Antipsychotic Pediatric Safety Trial (LAPS)
Funded by the DOD CDMRP Autism Research Program. April 12, 2019 - June 30, 2021
Description of Project: This is a 12-week randomized, double-blind study of CBDV vs. placebo in 100 child and adolescent subjects aged 5 to 18 years with a diagnosis of ASD. https://clinicaltrials.gov/ct2/show/NCT03202303
Goal: Cannabidivarin (CBDV) is a nonpsychoactive phytocannabinoid and a safe variant of Cannabidiol (CBD). It has no appreciable tetrahydrocannabinol (THC) [less than 0.01%], has been shown to have no impact on weight or metabolism, and improves both social and cognitive functioning in animal models of idiopathic and syndromal autism (Fragile X, Rett Syndrome, Angelman Syndrome). CBDV, like VPA, is effective in the treatment of pediatric epilepsy, and ASD mouse models demonstrate potential mechanisms for treatment with CBDV, including potential therapeutic effects on repetitive behaviors, irritability, sociability, and quality of life, and the capacity to reduce inflammation. This study aims to examine the efficacy and safety of cannabidivarin (CBDV) with a primary aim of studying its effect on irritability in children with ASD.
Funded by the FDA
April 11, 2018 to February 11, 2020.
Description of Project: This is an 8-week double-blind, randomized study in 50 children with PWS aged 5-17. Participation involves 5 in-person visits to our program and two telephone-call visits. Travel expenses will be reimbursed to participating families. https://clinicaltrials.gov/ct2/show/NCT03197662
Goal: Oxytocin has been implicated in the pathophysiology of PWS and there have been small studies of intranasal oxytocin (IN-OXT) in this population. To date, however, studies have not been adequately powered to detect significance in target symptoms of hyperphagia and associated symptoms of individuals with PWS. The primary goal of this study is to examine the safety and efficacy of IN-OXT on hyperphagia, as measured by the Hyperphagia Questionnaire- Clinical Trails, from baseline to week 8.
Funded by the Foundation for Prader-Willi Research (FPWR) and GW Pharmaceuticals June 1, 2020 to June 1, 2021.
Description of Project: This is a single-site 12-week double-blind placebo-controlled pilot study of CBDV manufactured by GW Pharmaceuticals as GWP42006 in 36 children and young adults aged 5 to 30 diagnosed with PWS and have a high level of irritability (≥18 on the ABC-I). https://clinicaltrials.gov/ct2/show/NCT03848481
Goal: This clinical research trial aims to study the efficacy and safety of cannabidivarin (CBDV), a naturally occurring homolog of the phytocannabinoid cannabidiol (CBD) in children and young adults with Prader-Willi Syndrome (PWS). CBDV has effects independent of CB1 and CB2 receptor activation and a good safety profile. This proposal addresses the Foundation for Prader Willi Research’s five year PWS Research Plan: Program 1, Clinical Care Research: seeks to evaluate treatments that aim to reduce behavioral symptoms, such as irritability, in order to improve the quality of life of both the individual with PWS and their families. GW Pharmaceuticals will provide the CBDV drug and matching placebo and additional funding to the site.
Funded by the Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
January 10, 2019 to September 10, 2021.
Description of Project: This is a multi-center, observational study that will include approximately 350 children being treated with risperidone and 350 children being treated with aripiprazole. The participants’ personal physicians will continue to prescribe their medications over the course of the study. Assessments will occur every six months at in-person visits, for 2 years.
https://clinicaltrials.gov/ct2/show/NCT03522168
Goal: The purpose of this study is to evaluate the long-term pathologic weight changes associated with multi-year risperidone or aripiprazole therapy in 3 - <18-year-old children, who have varying durations of prior antipsychotic drug exposure. This is critical because children appear to have greater vulnerability to antipsychotic-associated weight gain than adults, and obesity has significant effects on morbidity and mortality.
Autism and Obsessive Compulsive Spectrum Program Psychiatry Research Institute Montefiore-Einstein (PRIME) 1225 Morris Park Ave, Bronx, NY 10461 [email protected]