Research Unit on Pediatric Psychopharmacology Recruiting Participants for Innovative Studies

December 29, 2008

Research Unit on Pediatric Psychopharmacology Recruiting Participants for Innovative Studies
Nisonger Center, Ohio State University

The Research Unit on Pediatric Psychopharmacology (RUPP) at the Ohio State University Nisonger Center is a group of professionals engaged in pharmacological, psychiatric, behavioral, nutritional and alternative research in children and adolescents. The group includes psychiatrists, psychologists, pediatricians, a nurse, and other professionals as dictated by the research needs. The overarching goal of the OSU RUPP is to study the safety and effectiveness of pharmacological and other treatments for children and adolescents who have difficulties in behavior or functioning. This includes those with autism spectrum disorders, ADHD, disruptive behavior disorders (primarily conduct disorder and oppositional disorder) and other childhood disorders. Such treatments may range from classical psychotropic medicines to non-stimulant, nutritional, behavioral or other non-medical treatments. In addition, because these treatments aim to improve behavior and performance, we also develop various methods for assessing behavior and learning.
The OSU RUPP has extensive experience working with these populations on NIMH and industry-sponsored research studies. One such study conducted from 2003-2007 investigated the treatment of irritability and aggression associated with autism spectrum disorders. By the end of this study, a total of 53 children had enrolled at the OSU RUPP. The following describes the participation of a seven-year-old child with autism and significant intellectual disability. At the initial study visit, the child's parents stated that he experienced severe hyperactivity and irritability and had problems with destructive and repetitive behaviors. After 11 weeks of participating in the study, which involved training the parents in behavioral principles in addition to a proven medication for irritability, the parents began reporting improvements. By the end of the study, research assessments showed a marked decrease in irritability, hyperactivity, repetitive behaviors, and destructive behaviors and an improvement in self-help skills. In addition, the participant was rated as "very much improved" by study clinicians. It is the goal of the OSU RUPP to continue to conduct innovative research in the hopes of helping children and families who are currently struggling with a developmental disorder. The OSU RUPP is currently conducting the following research studies:

1. A placebo-controlled study of low-dose risperidone and the treatment of irritability and aggression associated with autistic disorder in children and adolescents, ages 5-17. The first phase of the study lasts 6 weeks. There is a ? chance of receiving a placebo during this time. Following the 6-week phase of the study, participants will be offered the option of trying open-label (known) risperidone for 26 weeks.
2. A placebo-controlled study of mecamylamine for the core symptoms of autism (social and communication skill impairment and repetitive behaviors) in children diagnosed with autistic disorder or pervasive developmental disorder-not otherwise specified (PDD-NOS), ages 4-12. The first phase of the study lasts 14 weeks and includes approximately 13 study visits. During this time there is a 40% chance of receiving the placebo and 60% chance of receiving active medicine. Following the initial phase of the study, there is a 10-week open trial of mecamylamine for participants who were randomized to the placebo group and did not improve.
3. An open study of melatonin for the treatment of sleep disturbances in autism spectrum disorder in children ages 5-12 years. Melatonin is a natural hormone regulating the onset of sleep and may improve attention and behavior. This is an 8-week study with no chance of placebo.
4. A placebo-controlled study of atomoxetine and parent management training (PMT) for the treatment of ADHD symptoms associated with autism spectrum disorders in children, ages 6-12. This is a 10-week study with a 50% chance of receiving a placebo. Fifty percent of participants will also receive PMT. Participants who respond positively to study treatment will have the option to continue for an additional 6 months.
5. A study of EEG neurofeedback for ADHD in children, ages 6-12 years. In this study, ? of participants will receive the EEG neurofeedback, while ? will receive a placebo treatment. Each participant will receive the treatments 2 or 3 times per week for a total of 40 sessions. Participants who receive the placebo treatment and do not improve will be offered the EEG neurofeedback training after completing the study.
6. The following study is expected to begin within the next 1-2 months: A placebo-controlled study of risperidone and Concerta for the treatment of ADHD and disruptive behavior disorder in children ages 6-12. All participants will receive Concerta and parent training in behavior management, and there is a 50% chance of receiving risperidone as well. The initial phase of the study will last 9 weeks, and medication responders will have an option of entering a 3-month extension. All participants will be asked to come back for a 1-year follow-up visit.

All study evaluations and treatments are free of charge to study participants, and there is some reimbursement for transportation. A full workup, including diagnostic assessment, is completed prior to treatment. A summary of all the child's study documents will be made available to their parents and/or family physician. For further information, please contact the researchers at 614-292-3698, or visit the website.