Psychiatry

  • Ongoing Research in the Division of Psychiatry

  • Show All

    + The Longitudinal Assessment of Manic Symptoms (LAMS, R01MH073816)

    LAMS, currently in its sixth year, is a collaborative, four-site study investigating long-term outcomes for children with low and high symptoms of mania. With funding support from the National Institute of Mental Health (NIMH), we are using epidemiological methods to follow a cohort of 6- to 12-year-old children with ESM, as well as a comparison group without ESM.

    We have enrolled and completed baseline assessments on 180 subjects in Cincinnati with 600 subjects being enrolled in total. The study will follow these subjects for the next 20 years to determine their long-term outcomes.

    + Double-blind Placebo-Controlled Study of Acamprosate in Youth aged 5 to 17 years with Autism

    In this research study we want to understand the effectiveness of a drug treatment, acamprosate, for interfering behaviors and core symptoms associated with autism. Acamprosate may help improve social and communication problems in people with autism. Blood draws, an eye-gaze assessment, and expressive language sampling will be used to assess effectiveness. The child’s parent will also submit a blood sample to serve as a control. This study includes an open-label extension following an initial placebo-controlled trial phase. This project is funded by Autism Speaks.

    + A Phase 2 Randomized Placebo-controlled Trial of of Levodopa in Angelman Syndrome

    The purpose of this study is to find out whether levodopa will lead to an improvement in the development and in the tremor in children with Angelman Syndrome (AS). The child receives study treatment with either levodopa or placebo for 1 year. The research team determines how the children with AS respond to the study treatment by doing some tests that will measure how well they are developing and certain substances in the blood. This study is open to children with a molecular confirmation of their diagnosis of AS between age 4 years and 12 years. Cincinnati Children’s is one of several sites participating in this project across the United States.

    + Angelman Syndrome Natural History Study

    The goal of this study is better understand Angelman Syndrome through a variety of tactics.

    • Examine how characteristics of AS relate to the type of genetic patterns found in children and adults. 
    • Provide information about the frequency with which autism co-occurs with AS.
    • Record the medical, behavioral and learning problems seen in people with AS.
    • Collect information about patients with AS over a five-year period (or longer) through yearly clinical visits.

    The hope is that doctors will be able to help patients with AS better if we understand the different pattern of symptoms that appear in individuals with AS over their lifetimes. Cincinnati Children’s is one of several sites participating in this project across the United States.

    + Rare Diseases Clinical Research Network Sleep Abnormalities in Rare Genetic Disorders: Angelman Syndrome, Rett Syndrome, and Prader-Willi Syndrome

    The purpose of this research study is to investigate sleep behavior in Angelman Syndrome, Rett Syndrome, and Prader-Willi Syndrome, and Early-onset Morbid Obesity.

    At Cincinnati Children’s Hospital Medical Center we will only be enrolling participants with Angelman Syndrome. The study will utilize questionnaires designed to identify sleep disorders and how they affect behavior and quality of life. The principal goals of this study are: to see how common sleep disorders are in individuals with Angelman Syndrome; to see how sleep disorders affect behavior in these individuals; to see whether sleep disorders and related behavior problems improve or worsen with age; to see how specific disease conditions relate to sleep disorders and how bad the sleep disorders are; to develop new treatment options to improve quality of life and behavior issues; and to evaluate current treatment options to improve sleep problems in these individuals.

    + A Randomized, Placebo-controlled Trial of D-Cycloserine for the Enhancement of Social Skills Training in Pervasive Developmental Disorders

    The purpose of this research study is to determine the usefulness of D-cycloserine for improving social impairment in children with pervasive developmental disorders (PDD). Social impairment includes things such as: relating to other children, learning and working with others, making friends, understanding social situations, developing interests and hobbies, thinking of others, getting along with others and everyday manners.

    In this study, D-cycloserine will be compared to a placebo. The new information learned from this study could then be used to start additional trials with children with pervasive developmental disorders. If D-cycloserine proves to work well and is safe in this population, it would become an important medication for the treatment of this population. This study will test the safety and effectiveness of D-Cycloserine in children with pervasive developmental disorders just prior to social skills training. In this study, D-cycloserine is being tested for the possible treatment of core social impairment in children with pervasive developmental disorders. This project has completed enrollment at Cincinnati Children’s Hospital Medical Center and is supported by the United States Department of Defense.

    + Extracellular Signal-related Kinase Activation Blood Biomarker in Autism Study

    The purpose of this research study is to develop a better understanding of potential causal factors contributing to the development of autism. Our blood biomarker development may help in early diagnosis of autism and may possibly predict severity of illness.

    This project is enrolling persons aged 3 to 25 years with autism, developmental delay without autism, and persons with normal development. The project additionally includes use of eye tracking to assess for difference in eye gaze in persons with autism. The project is supported by the Simons Research Foundation.

    + The Fragile X Clinical and Research Consortium Forward Registry and Database

    The purpose of this research study is to create a way to collect and combine data about people with fragile X syndrome (FXS) from clinics across the United States. This data will help establish the best ways to evaluate and treat people with FXS. It will also help us learn about families with a member affected by the fragile X mutation.

    The data will create a registry for fragile X researchers. It will help them find people with fragile X mutations and other people who wish to be in future studies. The parent and the child will complete three standardized behavioral assessments that assess a number of behaviors (e.g., social behaviors, communication, repetitive behaviors) yearly to help collect data on how problems linked to FXS change with age.

    Cincinnati Children’s Hospital Medical Center is one of many sites across the country participating in this project supported by the United States Centers for Disease Control and the National Fragile X Foundation.

    + A Double-blind, Placebo-controlled Proof of Concept Study of Acamprosate in Youth with Fragile X Syndrome

    The purpose of this research study is to understand the effectiveness of a drug treatment, acamprosate, for interfering symptoms (i.e., inattention/hyperactivity, social impairment) associated with Fragile X Syndrome (FXS) in youth aged 5 to 17 years. Acamprosate may help improve interfering symptoms in people with FXS. This study will help determine whether acamprosate shows evidence of effectiveness, safety, and tolerability in children with FXS. This project is supported by the John Merck Fund.

    + A Randomized, Double Blind, Placebo Controlled, Cross-Over Pilot Study of Riluzole for Drug-Refractory Irritability in Autism Spectrum Disorders

    The purpose of this research study is to test the safety and effectiveness of riluzole in adolescents with autism spectrum disorders. In this study we hope to learn about the medicine’s safety and effectiveness (usefulness) for treatment of aggression, self-injury, and tantrums in adolescents with autism spectrum disorder aged 12 to 25 years. In this study riluzole will be compared to placebo.

    The participant will participate in two periods of treatment during which he or she will receive 5 weeks of treatment with riluzole and 5 weeks of placebo, with a 2 week “wash-out” period between treatment arms. This project is supported by the University of Cincinnati Center for Clinical and Translational Science & Training.

    + A randomized, double-blind, 12-week, parallel-group, placebo-controlled, study of the efficacy and safety of RO4917523 in patients with Fragile X Syndrome

    This is a research study for an experimental oral medication (taken by mouth) called RO4917523 that is being developed to treat Fragile X Syndrome (FXS). The goal is to learn about the medicine’s safety, how well the child’s body manages the medicine (tolerability), how much medicine is in the child’s body (pharmacokinetics) and if it works on symptoms of FXS. Studies involving RO4917523 study in FXS are enrolling down to age 5 years at this time. This study is sponsored by The Roche Group.

    + SynapDx Autism Spectrum Disorder Gene Expression Analysis (STORY) Study

    The purpose of this research study is to develop a blood test and demonstrate how accurate the test is in identifying children who are diagnosed with autism spectrum disorders (ASD). Early studies suggest that this type of blood test may be able to help doctors identify children who are more likely to be diagnosed with ASD. The entire study will last approximately one year. This study is sponsored by SynapDx.

    + Uncovering the Neural Circuitry of Pediatric Aggression

    Our past and current research has focused on determining risk factors and biomarkers of pediatric aggression. As the first step, we developed the Brief Rating of Aggression by Children and Adolescents (BRACHA) which is predictive, valid, and reliable. Then, in a recent pilot study, we found a correlation between salivary hormone levels, BRACHA scores, and levels of pediatric aggression (measured with the Overt Aggression Scale (OAS) each shift) on the inpatient units.

    We have recently completed prospective data collection on over 3,000 unique psychiatrically hospitalized children and adolescents. In this database, we have BRACHA scores, OAS scores for each shift, and other clinical/demographic information. By analyzing this large database on aggression, we will be able to further validate the BRACHA and determine which items are most predictive of aggression.

    For the current pediatric aggression study, we are collecting fMRI data, salivary hormone levels, and BRACHA data on 11 child and adolescent participants to establish feasibility. Thus far, we have established the feasibility of the fMRI scan for pediatric aggression which measures brain activity during a frustrating task (the affective Posner task).

    + Effective Trauma Detection and Treatment in School-Aged Children

    The goal of this project is to build consensus among community school based mental health partners to make choices about screening instruments and target populations for future grant resources. This initial grant will hopefully lead to the full operation of our intended goal: the expansion of screening for childhood trauma and the provision of trauma treatment to children by community providers well trained in evidenced based trauma therapy.