Bipolar Disorder (Pediatric) Research Study
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Characterization and Pathophysiology of Severe Mood and Behavioral Dysregulation in Children and Youth
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This study seeks to describe and follow the symptoms of severe mood and behavioral dysregulation in children and adolescents and to understand the brain mechanisms that cause it. This study has two parts, and a child may participate in one or the other part. Part A involves hospitalization or Day Treatment with gradual tapering of medication followed by extensive behavioral testing and brain imaging while medication-free. Part B includes only the testing and brain imaging, without treatment.
Children and adolescents with mood and behavioral dysregulation display chronic anger, sadness, or irritability, as well as hyperarousal (such as insomnia, distractibility, hyperactivity) and extreme responses to frustration (such as frequent, severe temper tantrums). Study participants, ages 7 to 17, will be followed over time and their symptoms compared with those of children with bipolar disorder and healthy volunteers.
Participants in the treatment study will have any current medications gradually withdrawn over 2- to 8-weeks while in-patients at the NIH Clinical Center. Depending on clinical severity and whether they live locally to the NIMH, participants will either remain on the inpatient unit during the study or can attend the Behavioral Pediatrics Day Treatment Center. Structural magnetic resonance imaging (MRI), functional MRI (fMRI) scans will be obtained to learn about brain structure and function. In addition, participants receive extensive behavioral testing.
Following the medication-free period, patients will be offered standard medications that may be helpful based on the clinical judgment of the treatment team, parents, and outside providers. Participants will be asked to return once every 2 years for follow-up visits.
All procedures and medications associated with the research are provided at no cost to participants, and transportation expenses are reimbursed by NIMH. Schooling will be provided while on the inpatient unit or in day treatment.
Participants must be in treatment with a psychiatrist for mood dysregulation. Those in the longitudinal follow-along study are treated exclusively by their own local physicians.
To find out if you qualify or for more information, please call (301) 496-8381 or email us at bipolarkids@mail.nih.gov .
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Protocol Information |
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Bipolar Disorder (Pediatric) Research Study
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Clinical Trial of Citalopram and Methylphenidate in Severe Mood Dysregulation
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This study is testing the effectiveness of methylphenidate plus citalopram vs. methylphenidate plus placebo for decreasing irritability in children with severe mood dysregulation (SMD). Children with SMD display chronic anger, sadness, or irritability, as well as hyperarousal (such as insomnia, distractibility, hyperactivity) and extreme responses to frustration (such as frequent, severe temper tantrums).
Children ages seven to 17 with SMD may be eligible to participate in this 12- to 15-week inpatient or outpatient study. This study has four phases. During Phase I participants are gradually withdrawn from all current psychotropic medications. Phase II is a one-week psychotropic medication-free period. During Phase III, which lasts two weeks, participants are treated with methylphenidate alone. Phase IV lasts for eight weeks. During this time, participants continue methylphenidate treatment and are randomly assigned to also receive either citalopram or placebo.
At the end of the study, those who received methylphenidate plus placebo will have the opportunity to receive methylphenidate plus active citalopram if clinically appropriate.
All procedures and medications associated with the research are provided at no cost to participants, and transportation expenses are reimbursed by NIMH. Schooling will be provided while on the inpatient unit or in day treatment.
To find out if you qualify or for more information, please call (301) 496-8381 or email us at bipolarkids@mail.nih.gov.
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Disease and Treatment Information |
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Bipolar Disorder (Pediatric) Research Study
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Phenomenology and Neurophysiology of Pediatric Bipolar Disorder
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This study seeks to learn more about bipolar disorder in children and adolescents. The objectives are to describe the course of moods and behaviors of children with bipolar disorder and to learn about changes in the brain that are associated with these symptoms. There are three separate parts to the study. Patients may participate in one or more parts.
Part A is not a treatment study. In part A participants remain in treatment with their community psychiatrist. They do not receive any experimental treatment, but they do receive extensive testing and brain imaging.
In Part B children receive extensive testing and brain imaging off medications.
Part C (the high risk study) is a study of children and adolescents who have a parent, brother or sister with bipolar disorder. These children receive a clinical assessment and testing.
Families who are interested in participating are interviewed by telephone. Those who are judged to be likely to meet criteria for the study are invited to the NIMH.
In Part A, participants first come for one day of interviews to determine if they meet study criteria. Those patients who are accepted return for a 5-day baseline evaluation, including physiologic tests and procedures, neuropsychological testing, and questionnaires and interviews about mood and behavior. In addition, staff members obtain a medical and psychiatric history of the patient and extended family members, and a physical and neurological evaluation. Participants are asked to perform computer and written tests to assess intelligence, memory, learning, motor skills, reaction time, and planning skills. Psychophysiological measures (such as heart rate, skin conductance, and electroencephalogram) are obtained in response to emotions and while playing computer games. Participants are asked to give blood samples for blood count and thyroid levels, liver and kidney function and to check for other diseases. Structural magnetic resonance imaging (MRI) and functional MRI (fMRI) scans of the brain are obtained.
Participants and parents return to the NIH for repeat evaluations and physiologic tests after 2 months, and then every 3 months until 12 months have passed from the first visit. Thereafter, visits are every 6 months for 4 years, and then every year until the patient turns 25. Some visits will involve only interviews and questionnaires, some will also include a physical exam, behavioral tests, or repeat brain imaging. Patients, their parents and siblings will also be asked to have blood drawn to obtain a DNA sample for genetic studies.
In Part B, participants come into the NIH Clinical Center and are gradually removed from all their medications. While off medication, they receive up to two weeks of research studies, like those described above for Part A. Participants are then given appropriate medication and stabilized before returning home.
In the High Risk Study, children of parents with bipolar disorder, or parents and siblings of children with bipolar disorder come for 1-3 days of clinical interviews and assessment, as well as test procedures performed on computers.
All tests and procedures are provided free of charge, and travel expenses are paid by the NIMH.
To find out if you qualify or for more information, please call (301) 496-8381 or email us at bipolarkids@mail.nih.gov.
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Protocol Information |
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