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University of Nebraska Medical Center

Studies

Current Studies

The UNMC Center for Neuro-Developmental Psychopathology is engaged in a number of  clinical research studies:

Virtual reality assessment of behavioral manifestation of attention deficit hyperactivity disorder

IRB PROTOCOL # 0580-23-FB

The study aims to determine 1) the correlation pattern among symptom profiles of ADHD, behavioral data from VR cognitive tasks, and overall functional impairment in healthy children as well as children with diagnosis of ADHD ages 6-13; 2) assessment of subjective experience by using VR assessment tool by the participants and their parents.

A Phase 3, randomized, double-blind, 52-week study of OLZ/SAM vs. Olanzapine to evaluate weight gain as assessed by change in BMI Z-score in pediatric subjects with schizophrenia or bipolar I disorder

ALKS 3831-A312

The primary objective of this study is to compare changes in body mass index (BMI) Z-score following 12 weeks of treatment with OLZ/SAM vs olanzapine in pediatric subjects diagnosed with schizophrenia or bipolar I disorder.

Investigating the impact of oxytocin on irritability/emotional dysregulation in children and adolescents with disruptive behavior and mood disorders, and the possible mediating role of amygdala activity

IRB PROTOCOL # 0219-20-FB (NIMH: U01MH120155-01A1)

The overall aim of this study is to characterize the pharmacodynamic/pharmacokinetic models of intranasal oxytocin (OXT) by identifying the associations among intranasal OXT doses (8IU, 24IU, 48IU, 80IU, and placebo), OXT plasma concentrations (area under curve [AUC]), and neural responses to emotional stimuli in youths with high levels of irritability.

Click to participate in the study 

Biomarkers of mood and emotional symptoms in youth

IRB PROTOCOL # 0434-22-EP

The study aims to establish biomarkers of mood and emotional symptoms in youth who are in treatment at the outpatient clinic of UNMC/Nebraska Medicine Department of Psychiatry for psychiatric assessment/treatment (ages 10 to 18). The study aims to establish biomarkers of mood and emotional symptoms in youth to achieve better characterization of the mood and emotional symptoms by objective and congregated subjective data. This will serve for the next step to achieve better understanding of neurobiological mechanisms of mood and emotional symptoms in youths, deliver appropriate and adequate level of treatment, and determine treatment response.

Symptom profiles and neuropsychological task behavioral data for children with disruptive behavior and emotional problems

IRB PROTOCOL # 0586-16-EP

The purpose of this study is to assess symptom profiles and behavioral data (reaction time and accuracy) of the neuropsychological tasks before and after treatment provided by the treatment centers (Day Break and the outpatient clinic of the UNMC Department of Psychiatry). This will be used for analyses of: 1) symptom profiles such as callous-unemotional trait, irritability/emotional dysregulation, proactive/reactive aggression, ADHD symptoms and symptoms of Asperger's Disorder; and 2) related behavioral data yielded from the neuropsychological tasks. Children ages 5 to 18 who come to clinics for evaluation/treatment for their behavioral and emotional problems will provide the data. This will elucidate 1) the symptom profiles and behavioral data at baseline and their relation to diagnosis, 2) the predictability of symptom profiles and behavioral data of the neuropsychological tasks of response to treatment, 3) their potential roles as mediators and moderators for their treatment response, and 4) changes of symptom profiles and behavioral data at the end of the treatment provided by the treatment program.

An exploratory pilot study of palliadelic treatment to reduce psychological distress and improve quality of life in pancreatobiliary cancers patients with a parallel assessment of health care utilization and family well-being:

IRB PROTOCOL # 0860-21-FB

The purpose of this study is to establish the feasibility of conducting a clinical trial using a psilocybin-based intervention to treat psychological distress in participants with inoperable pancreas or biliary tract cancer in the outpatient palliative care setting. Feasibility will be determined by: 1) recruitment, screen failure and retention rates; 2) to demonstrate safety of psilocybin treatment in participants with pancreas and biliary tract cancers; and 3) logistic/ implementation objectives: a) development of an intervention manual for future trials; b) develop replicable schedule for intervention to accommodate the demands of anti-cancer treatment; and c) develop training manual for guides.

Completed Studies

Dose-response relationship and pharmacokinetics of intranasal oxytocin on the neural impact in youths with high levels of irritability

The primary objective of this research is to determine the impact of oxytocin on irritability and emotional dysregulation in children and adolescents with DSM-V disruptive mood and behavior disorders. I will also examine the impact of oxytocin on the neural response in the amygdala as well as fronto-amygdala connectivity dysfunction related to irritability and emotional dysregulation in children and adolescents, using fMRI and MEG. Changes in symptom profiles as a result of oxytocin treatment will be assessed for correlation with neural level changes. Differences in the magnitude of treatment responses to oxytocin as a function of polymorphisms in the oxytocin receptor (OTR) will also be assessed.

Investigating the impact of fluoxetine treatment on BOLD response in trauma-exposed patients with Conduct Disorder and Oppositional Defiant Disorder and the relationship of this impact with symptom improvement: Data analysis and publication

IRB PROTOCOL # 0491-16-EP

This protocol is designed to determine the impact of fluoxetine treatment on BOLD response in trauma-exposed patients with Conduct Disorder (CD) and Oppositional Defiant Disorder (ODD) and the relationship of this impact with symptom improvement.

The purpose of the registry is to transfer the data obtained from the study being conducted in Kyungpook National University Hospital/School Mental Health Research and Resources Center for data analysis and publication.