Status message

Active context: kki_bg_colors_yellow

Clinical Research Projects

Studies of the Link between Autism and Epilepsy
Principal Investigator:
Ewen, Joshua
This research consists of a retrospective record review to examine the link between autism, epilepsy and other clinical symptoms (including, but not limited to, intellectual disability, motor...
Electrophysiological Studies of Attention and Perception
Principal Investigator:
Ewen, Joshua
This protocol is designed to allow for the recruitment of healthy adult volunteers in order to perform studies of attention and perception in human cognition. The primary purpose of this data...
Pilot Studies for Event-Related Potential Experiments
Principal Investigator:
Ewen, Joshua
This protocol is designed to allow for the recruitment of healthy adult volunteers in order to pilot new paradigms for event-related potential (ERP) research. Since a significant portion of the...
Electrophysiological Studies of Autism
Principal Investigator:
Ewen, Joshua
Abnormalities of cortical connectivity have long been suspected to be responsible, at least in part, for the autism phenotype. Research to date has used a number of modalities, but none has the time...
Masqueraders of Cerebral Palsy
Principal Investigator:
Fatemi, S. Ali
Genetic conditions that manifest movement and postural impairment at perinatal or early childhood periods are often diagnosed with cerebral palsy. Identifying masqueraders of cerebral palsy...
Patient attitudes toward informed consent regarding incidental findings in whole exome sequencing
Principal Investigator:
Fatemi, S. Ali
The objective of this study is to assess the association between school-based transition planning and health care transition planning for youth with special healthcare needs (YSHCN). The 2011...
Genetic Causes of Intellectual Disability
Principal Investigator:
Fatemi, S. Ali
The purpose of this study is to define the biochemical and genetic basis of peroxisomal disorders and to develop new methods for prevention and treatment. The study obtains samples of blood or skin...
ALD Connect
Principal Investigator:
Fatemi, S. Ali
Adrenoleukodystrophy (ALD) is an X-linked disorder with several phenotypes ranging from childhood to adulthood. The objective of ALD Connect is to create a patient-centered clinical research network...
A Phase Ill, Randomized, Double-Blind, Placebo­ Controlled, Parallel-Arm, Multi-Center Study Measuring the Efficacy and Safety of Prc-063 in Adolescent ADHD Patients
Principal Investigator:
Findling, Robert
This is a parallel, randomized, double-blind, forced-dose titration, multicenter, placebo­ controlled, phase 3 study to evaluate the safety and efficacy of PRC-063 (methylphenidate hydrochloride...
A 6-Week, Randomized, Multicenter, Double-Blind, Parallel, Flexed- and Fixed-Dose Study Of Mg01ci (Metadoxine Extended-Release) 700 Mg and 1400 Mg Compared With Placebo in Adults and Adolescents With Fragile X Syndrome
Principal Investigator:
Findling, Robert
The study medication, MG01CI (Metadoxine Immediate-release/Slow-release Bilayer Tablet), is being investigated for the treatment of Fragile X Syndrome (FXS) in adults and adolescents. The purpose of...
A Phase 1, Multicenter, Open-label, Dose-Escalation Trial to Assess the Safety, Tolerability and Pharmacokinetics of Oral Brexpiprazole (OPC-34712) in Adolescents with Schizophrenia
Principal Investigator:
Findling, Robert
This is a phase 1, multicenter, open-label, dose-escalation trial in adolescent subjects (age 13 to 17 years) with a diagnosis of schizophrenia. This trial consists of a screening period (3 to 42...
A Phase 3, 12-Month, Multicenter, Open-label, Flexibly-dosed, Safety Study of SEP-225289 in Adults with Attention Deficit Hyperactivity Disorder (ADHD)
Principal Investigator:
Findling, Robert
To evaluate the long-term safety and tolerability of SEP-225289 in adult subjects with ADHD by the incidence of adverse events (AEs; or serious AEs), AEs (or SAEs) leading to discontinuation.
A 6-Month Study to Evaluate the Safety, Tolerability and Efficacy of Desvenlafaxine Succinate Sustained-Release (Dvs Sr) Tablets in the Treatment of Children and Adolescent Outpatients with Major Depressive Disorder
Principal Investigator:
Findling, Robert
A 6-Month, Open-Label, Multi-Center, Flexible-Dose Extension Study to the B2061032 Study to Evaluate the Safety, Tolerability and Efficacy of Desvenlafaxine Succinate Sustained-Release (Dvs Sr)...
A Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety and Tolerability of Desvenlafaxine Succinate Sustained-Release (Dvs Sr) in the Treatment of Children and Adolescent Outpatients with Major Depressive Disorder
Principal Investigator:
Findling, Robert
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety and Tolerability of Desvenlafaxine Succinate Sustained-Release (Dvs Sr) in the...
D1050302: A 104-week, flexible-dose, open-label, multicenter, extension study to evaluate the long-term safety and effectiveness of Lurasidone in pediatric subjects with schizophrenia and subjects with irritability associated with autistic disorder
Principal Investigator:
Findling, Robert
This open-label extension study is designed to evaluate the safety, tolerability, and effectiveness of lurasidone for the treatment irritability in individuals with autistic disorder. As an extension...
A Randomized, Double-Blind, Multicenter, Placebo-controlled, Parallel-group, Efficacy and Safety Study of 2 Doses of Dasotraline in Adults with Attention Deficit Hyperactivity Disorder (ADHD)
Principal Investigator:
Findling, Robert
To evaluate the efficacy and safety of dasotraline (4mg/day and 6 mg/day) compared with placebo in adult subjects with ADHD as measured by change from baseline at Week 8 in ADHD symptoms assessed...
A Phase 3, multicenter, three-week, randomized, double-blind, placebo-controlled, parallel-group efficacy and safety trial of flexible doses of oral Ziprasidone in children and adolescents with Bipolar I disorder (current or most recent episode manic)
Principal Investigator:
Findling, Robert
This will be a Phase 3, multicenter, 3-week, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy, safety, and tolerability of flexibly dosed ziprasidone...
A Multicenter, Double-blind, Placebo- and Active-Controlled Parallel-Group Evaluation of the Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder
Principal Investigator:
Findling, Robert
The objective of this study is to evaluate the efficacy, safety, and tolerability of vilazodone compared with placebo in pediatric outpatients (7-17 years of age) with MDD. In addition, the study is...
An adaptive, phase IIB/III, double-blind, randomized, placebo-controlled, multi-center study of the safety and efficacy of NaBen® (sodium benzoate), a d-amino acid oxidase inhibitor, as an add-on treatment for schizophrenia in adolescents
Principal Investigator:
Findling, Robert
Phase IIb Objectives: The primary objective of the Phase IIb portion of this study is to evaluate NaBen® (sodium benzoate) (1000 mg/day) safety and effectiveness and to determine the final sample...
Interventional, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study of Vortioxetine in Adults with Attention Deficit Hyperactivity Disorder (ADHD)
Principal Investigator:
Findling, Robert
Primary Objective: To evaluate the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on ADHD symptoms in the treatment of adult patients with a DSM-5™ diagnosis of ADHD....
Validation Study of the Aggression Diary
Principal Investigator:
Findling, Robert
The primary objective of this study is to conduct psychometric tests on the electronic observer- reported (eObsRO) Aggression Diary to evaluate whether the diary is a valid and reliable measure for...
A Phase 2, Exploratory Safety, Tolerability, Pharmacokinetic, and Efficacy Study of SPD489 in Preschool Children Aged 4-5 Years with Attention-Deficit/Hyperactivity Disorder (ADHD)
Principal Investigator:
Findling, Robert
A Phase 2, Open-label, Multicenter, Exploratory Safety, Tolerability, Pharmacokinetic, and Efficacy Study of SPD489 in Preschool Children Aged 4-5 Years with Attention-Deficit/Hyperactivity...
12708A: An open-label study evaluating the Pharmacokinetics and Tolerability of Lu AA21004 in connection with multiple oral dosing of Lu AA21004 in child and adolescent patients with a DSM-IV-TR(TM) diagnosis of Depressive or Anxiety Disorder
Principal Investigator:
Findling, Robert
This open-label study will evaluate the pharmacokinetic, tolerability and safety profiles of Lu AA21004 in connection with a multiple oral dosing in child and adolescent patients with a DSM-IV-TR...
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed Dose Study of Nnz-2566 in Fragile X Syndrome
Principal Investigator:
Findling, Robert
The purpose of this study is to look at the safety of NNZ-2566 for adolescents and adults with Fragile X Syndrome and to determine the drug properties (pharmacokinetic) of NNZ-2566 in people with...
A0501093: SPRITES: SERTRALINE PEDIATRIC REGISTRY FOR THE EVALUATION OF SAFETY: A Non-Interventional, Longitudinal, Cohort Study to Evaluate the Effects of Long-Term Sertraline Treatment in Children and Adolescents
Principal Investigator:
Findling, Robert
The primary objectives are to evaluate the long-term impact of treatment with sertraline on aspects of cognition, emotional and physical development, and pubertal maturation. Secondary objectives...
A Multi-Center, Randomized, Double-Blind, 12-Week, Parallel Group, Placebo-Controlled Proof of Concept Study to Investigate the Efficacy and Safety of RO5285119 in Individuals with Autism Spectrum Disorders (ASD)
Principal Investigator:
Findling, Robert
The main objective of this study is to evaluate the efficacy of 12-week treatment with RO5258119 compared with placebo in treating social communication deficits in adult individuals with ASD as...
VLZ-MD-21: A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Vilazodone in Adolescent Patients with Major Depressive Disorder
Principal Investigator:
Findling, Robert
Purpose This is a double-blind, randomized, placebo-controlled, fixed-dose trial designed to evaluate the efficacy, safety, and tolerability of vilazodone for the treatment of major depressive...
A Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of Circadin® to Alleviate Sleep Disturbances in Children with Neurodevelopmental Disabilities
Principal Investigator:
Findling, Robert
The purpose of this study is to establish the efficacy and safety of Circadin in children with neurodevelopmental disorders and to determine the dose, this randomized, placebo-controlled study is...
A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Flexible Dose, Parallel-Group Study To Evaluate The Efficacy And Safety Of Lurasidone In Children And Adolescent Subjects With Bipolar I Depression
Principal Investigator:
Findling, Robert
To evaluate the efficacy of lurasidone (20 - 80 mg/day flexibly dosed) compared with placebo in children and adolescent subjects with bipolar I disorder, most recent episode depressed, with or...
A Multi-Country Analysis of Patients with Chronic Myeloid Leukemia
Principal Investigator:
Gary, Devin
This application is based on a study that was originally carried out and completed at George Washington University. All of the data for this study has been collected. No new data will be collected at...
Retrospective Chart Review of Growth in Osteogenesis Imperfecta
Principal Investigator:
Germain-Lee, Emily
The purpose of this research is to assess the growth parameters(height and weight) in osteogenesis imperfecta during infancy, childhood, and adolescence with the ultimate goal of determining whether...
Studies of Hormone Action in Patients with Altered G-protein-coupled Signal Transduction
Principal Investigator:
Germain-Lee, Emily
Includes Substudies Entitled: "Study of Growth Hormone Secretion in Patients with Pseudohypoparathyroidism Type 1a (R01 FD002568)" and "Phase 2 Growth Hormone for Treatment of Albright Hereditary...
Predictive Value of Perinatal Biomarkers Following Very Preterm Birth for Cerebral Palsy and Developmental Delay at Age 24 Months
Principal Investigator:
Gerner, Gwendolyn
Neurologic injury identified in neonates soon after pre-term birth may either completely resolve or lead to life-long disabilities, including cerebral palsy (CP), that are a severe burden for these...
Features of Self-Injury in TSC
Principal Investigator:
Gipson, Tanjala
Our objective in this study is to look at the feasibility of collecting de-identified data on the topography, severity, and frequency of disruptive behaviors in TSC using an on-line survey.
Interdisciplinary Protocol for Patients with TSC
Principal Investigator:
Gipson, Tanjala
The major features of Tuberous Sclerosis Complex (TSC) are abnormalities of the brain –cortical tubers, subependymal nodules and subependymal giant cell astrocytomas; skin –hypomelanotic macules,...
Rapamycin for Autism Phenotype & seizures in Tuberous Sclerosis (RAPS)
Principal Investigator:
Gipson, Tanjala
Tuberous sclerosis complex (TSC) is associated with autism and seizures. Recent studies in animals using rapamycin have shown cognitive improvement. Human studies have demonstrated a reduction in...
Rapalogues for Autism Phenotype in TSC: A Feasibility Study
Principal Investigator:
Gipson, Tanjala
Tuberous sclerosis complex (TSC) is associated with autism and seizures. Recent studies in animals using rapamycin have shown cognitive improvement. Human studies have demonstrated a reduction in...
CRAD001M2304: A three-arm, randomized, double-blind, placebo-controlled study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizures
Principal Investigator:
Gipson, Tanjala
This study will investigate the efficacy and safety of everolimus, as adjunctive treatment, in patients ages 2-65 years with Tuberous Sclerosis Complex (TSC) that have refractory partial-onset...
Reward System in Autism
Principal Investigator:
Goldberg, Melissa
It is a core feature of autism that social interactions appear to be far less rewarding for autistic children compared to typically developing children. Based on this observation, one would predict...
An evaluation of differential reinforcement on appropriate toy skills
Principal Investigator:
Gonzalez, Melissa
The purpose of the current study will be to increase the play skills for six children with developmental disabilities, who display limited interest in toys in a free operant setting. It is...
Program evaluation of caregivers' behavioral workshop
Principal Investigator:
Gonzalez, Melissa
The Pediatric Feeding Disorders Program at Kennedy Krieger Institute provides services aimed at establishing appropriate feeding responses for children who present with a variety of feeding...
Evaluation of Assessment and Treatment Data in Individuals with Intellectual/Developmental Disabilities
Principal Investigator:
Hagopian, Louis
The purpose of this retrospective record review is to develop a database to evaluate the efficacy and efficiency of behavior analytic procedures in assessing and treating severe problem behavior.
Translational Analyses of Chronic Aberrant Behavior Across the Lifespan
Principal Investigator:
Hagopian, Louis
The goal of the proposed line of research is to gain a better understanding of the processes that evoke and maintain severe problem behavior (i.e., chronic aberrant behavior) in persons with...
Behavioral Economics in MR/DD and Behavior Disorders (2)
Principal Investigator:
Hagopian, Louis
Assessments of severe behavior disorders of children with intellectual and developmental disabilities (IDD) have revealed that behavior problems are often maintained by their functional outcomes (or...
Delineating subtypes of self-injurious behavior maintained by automatic reinforcement
Principal Investigator:
Hagopian, Louis
Self-injurious behavior (SIB) is one of the most serious problems experienced by individuals with intellectual disabilities. The standard of care for the assessment of SIB involves conducting a "...
Pediatric Psychology Consultation-Liaison Services: A Review of Clinical Practice and Patterns
Principal Investigator:
Hendricks, Melissa
Pediatric psychology consultation-liaison (CL) service is the most active form of collaboration between pediatric psychologists and health care specialists. The proposed study is a combination of...
Evaluation and Development of the IIAM (Important Information About Me) iPad App
Principal Investigator:
Hoon, Alexander
In 2011 a multidisciplinary group at Kennedy Krieger Institute and Johns Hopkins created IIAM (Important Information About Me) as a "voice" for those who cannot "speak”.IIAM is an innovative and...
IIAM (Important Information About Me): The Ongoing Development of A Novel iPad App
Principal Investigator:
Hoon, Alexander
In 2011 a multidisciplinary group at Kennedy Krieger Institute and Johns Hopkins created IIAM (Important Information About Me) as a "voice" for those who cannot "speak”. IIAM is an innovative and...
Interrelationships among quantitative measures of white matter injury, sensorimotor function and learning profiles in children with cerebral palsy
Principal Investigator:
Hoon, Alexander
Injury to white matter pathways is strongly associated with the severity of spastic diplegia in children born preterm. In previous research, we have shown that there is preferential injury in sensory...
Parental Feedback on the Phelps Center Visual Diagram
Principal Investigator:
Hoon, Alexander
The purpose of this research study is to collect parental feedback on a clinic-developed visual diagram utilized by Dr. Alec Hoon at the Phelps Center for Cerebral Palsy and Developmental Medicine at...
Quantitative mapping of the basal ganglia and related structures in children with dyskinetic cerebral palsy
Principal Investigator:
Hoon, Alexander
Cerebral palsy (CP) refers to a group of motor-impairment syndromes secondary to genetic and acquired disorders of early brain development.  When the underlying disorder affects the basal...
Comparison of Executive and Adaptive Skills in Individuals Diagnosed with Brain Tumor versus ADHD
Principal Investigator:
Jacobson, Lisa
Neuropsychological assessment and screening is a useful means of identifying cognitive deficits in children and adolescents. Expansion of availability of instruments has now permitted an examination...
Psychotropic Medication Use at The Center for Child and Family Traumatic Stress: A 4-Year Analysis
Principal Investigator:
Jamora, Mariflor
There have been recent concerns about excessive and inappropriate use of psychotropic medication in foster children, sparked by the recent GAO (Government Accountability Office) report in 2011....
Clinical Trials Center Intake, Registry and Questionnaire Database Project
Principal Investigator:
Johnston, MIchael
The Objectives of this protocol are: a. To create a standard intake process for individuals interested in possible participation in clinical trials at the Clinical Trials Unit (CTU), as well as to...
Student-Centered Behavioral Interventions to Reduce Challenging Behavior in the Classroom
Principal Investigator:
Kahng, SungWoo
Aggressive behavior in young children is a known risk factor for youth violence (CDC, 2011). New methods for preventing youth violence and juvenile delinquency are needed to address this growing...

Pages