Research in Autism & OCD Fellowship

Overview

Our program is located on the Moses campus of Montefiore Medical Center. In the upcoming year, we will be moving to the Psychiatry Research Institute at Montefiore Einstein (PRIME) in the Van Etten Building at the Albert Einstein College of Medicine.

The Autism and Obsessive Compulsive Spectrum Program and the Anxiety and Depression Program at the Albert Einstein College of Medicine and Montefiore Medical Center are dedicated to three broad goals:

  1. Developing innovative, novel and breakthrough treatments for a unique group of overlapping conditions
  2. Clarifying neurobiological mechanisms that underlie core symptom domains across these conditions.
  3. Providing world-class care to our research participants

Our Autism and Obsessive Compulsive Spectrum Program focuses on Autism Spectrum Disorders (ASD), Prader-Willi Syndrome (PWS), and Obsessive Compulsive Spectrum Disorders such as Obsessive Compulsive Disorder (OCD), Body Dysmorphic Disorder (BDD), Intermittent Explosive Disorder (IED) and Tourette Syndrome (TS).

The Anxiety and Depression Program focuses on treatment of resistant depression and anxiety disorders.

Our work seeks to bridge and translate basic neuroscience discoveries into innovative experimental therapeutics and new clinical treatments. Our expert group of psychiatrists, psychologists and investigators consider our patients as partners in growing the knowledge base for our field.

Our clinical orientation is translational. We utilize neuroscience discoveries to develop and launch breakthrough treatments. We use behavioral, cognitive and early efficacy biomarker assessments (i.e. eye tracking) to determine the impact of treatments on clinical symptoms and the underlying endophenotype (measures of the condition that lie in-between genes and clinical symptoms). We perform our intensive diagnostic, neuropsychological and safety measures in the Montefiore/Einstein Clinical Research Center.

Dr. Hollander has been the PI of 10 federal grants, authored 528 publications, has 22,574 citations and an h-index of 84. He is a 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. The program has received funding from the Department of Defense, and the Orphan Products Division of FDA, for autism, body dysmorphic disorder, and Prader Willi Syndrome. The program has developed targeted treatments for the repetitive behavior domain and the social communication domain of autism spectrum disorder.

 

Key Collaborators

Our program actively collaborates with the Einstein-Montefiore Institute for Clinical and Translational Research (ICTR) and other clinical investigators at Montefiore/Einstein.

We were recently awarded funding by the Department of Defense Autism Research Program to study Cannabidivarin (CBDV) vs. Placebo in Children with Autism Spectrum Disorder (ASD). This study is being conducted in collaboration with Dr. Orrin Devinsky, director of NYU Langone’s Comprehensive Epilepsy Center and GW Pharmaceuticals. The primary aim is to compare changes in irritability from baseline to endpoint between the treatment and placebo groups. The secondary aims include comparing repetitive behaviors, social communication, quality of life, and adaptive behavior.

We also received funding from the Orphan Products Division of the Food and Drug Administration to study Intranasal Oxytocin vs. Placebo for the Treatment of Hyperphagia in Children and Adolescents with Prader-Willi Syndrome (PWS). In this study we will determine if intranasal oxytocin is effective in reducing hyperphagia in PWS as measured by changes on the Hyperphagia Questionnaire-Clinical Trials (HQ-CT). We will also examine secondary outcomes of changes in repetitive behaviors, quality of life, and salivary oxytocin concentration as well as examine genetic correlates with study outcome.

We also received funding from Eunice Kennedy Shriver National Institute of Child Health and Human Development, part of the National Institutes of Health, to study Long-term Antipsychotic Pediatric Safety (LAPS). In this trial the primary objective is evaluate the long-term pathologic weight changes associated with multi-year risperidone or aripiprazole therapy in 3 –18 y.o. children who have varying durations of prior antipsychotic drug exposure from the start of study Month 0 (M0). The second objective is to evaluate the overall safety of multi-year risperidone and aripiprazole therapy in 3 -18 y.o. children by assessing long-term changes in safety outcomes of special interest, evaluate the potential long-term benefits of risperidone and aripiprazole and estimate pharmacokinetic parameters of risperidone and aripiprazole in normal weight children 6 – <10 years and obese children 6 – <18 years.

Our program has worked with 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, and Coronado Biosciences

Foundations that have provided funding for our research include the Foundation for Prader-Willi Research and the Simons Foundation Autism Research Initiative (SFARI).

Current Studies 

  1. Cannabidivarin (CBDV) vs. Placebo in Children with Autism Spectrum Disorder (ASD) (Department of Defense Autism Research Program)
  2. A Phase 2 Study Intranasal Oxytocin vs. Placebo for the Treatment of Hyperphagia in Prader-Willi Syndrome (Orphan Products Division of the Food and Drug Administration)
  3. Long-term Antipsychotic Pediatric Safety Trial (LAPS) (Funded by the National Institute of Child Health and Human Development (NICHD)
  4. A Phase 2 multi-center, randomized, double blind, 24-week, 3 arm, parallel group, placebo controlled study to investigate the efficacy and safety of R05285119 in children and adolescents age 5-17 with autism spectrum disorder (ASD) ( F. Hoffmann-La Roche Ltd)
  5. An Open-Label Extension Study of CM-AT for the Treatment of Children with Autism (Curemark LLC).
  6. A Randomized, Double-Blind, Placebo-Controlled, Phase 4, Relapse Prevention Study Evaluating the Efficacy and Safety of Vortioxetine (5, 10 and 20 mg) in Adults With Major Depressive Disorder (Takeda)
  7. A Phase 2, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide d6-DM/quinidine sulfate Q) for the treatment of Intermittent Explosive Disorder (IED) (Avanir)
  8. A phase 2b, randomized, double-blind, placebo controlled, dose optimization study to assess the safety, tolerability, and efficacy of NBI-98854 for the treatment of pediatric subjects with Tourette syndrome (Neurocrine Biosciences)
  9. A Double-Blind, Placebo-Controlled Study of Brexpiprazole plus Ketamine in Treatment-Resistant Depression (collaboration with Dr. Jonathan Alpert and MGH, PI Maurizio Fava, MD) (Otsuka Pharmaceuticals)