"More and more clinicians are using second generation anti-psychotics to treat children with bipolar disorder, but there are no randomized controlled trials of these medications," said Dr. Mani Pavuluri, director of the Pediatric Mood Disorders Clinic at UIC and principal investigator of the study.
The study is innovative because it was designed so that all kids receive active, yet double-blinded, treatment and brain function testing, Pavuluri said.
Bipolar disorder, also known as manic-depression, is characterized by extreme changes in mood. Patients may alternate between deep depression and abnormal and persistent euphoria, or mania.
In children, the disorder is associated with sexual promiscuity, failure in school, and suicide. It is often misdiagnosed and treated unsuccessfully.
In the first phase of the study, researchers will enroll about 30 children between the ages of 5 and 18 with bipolar disorder. During the six-week clinical trial, children will be randomly assigned to receive either risperidone (a novel antipsychotic) or divalproex sodium (a standard mood stabilizer).
Researchers will closely monitor the patient's physical and mental health during the study. The child, the child's parents and teacher will be asked to complete questionnaires regarding how the child thinks and behaves while participating in the study.
In the second phase of the study, a subset of children between the ages of 12 and 18 who are enrolled in the drug trial will be evaluated using functional magnetic resonance imaging, known as fMRI.
The non-invasive procedure allows researchers to map brain activity when patients perform specific tasks or are exposed to specific stimuli. The functional MRI testing will take place before and after receiving medication.
Fifteen healthy children of comparable age and sex will be recruited to complete the functional MRI studies and serve as a control group for the study.
"This trial not only looks at drug efficacy using paper and pencil measures, but includes fMRI to look at pre- and post-blood flow alterations in the brain indicating functional changes," said Pavuluri.
Existing treatment strategies for pediatric bipolar disorder are often inadequate and not well tolerated, according to Pavuluri. The study aims to identify whether a novel antipsychotic will offer a more favorable response with fewer side effects than a standard mood stabilizer.
The National Institutes of Health is funding the study. For more information about the clinical trial, call (312) 413-1710.
For more information about the Pediatric Mood Disorders Clinic, visit www.psych.uic.edu/pmdc
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