Studies of Brain Function and Course of Illness in Pediatric Bipolar Disorder
|First Received Date ICMJE||October 31, 2001|
|Last Updated Date||February 2, 2017|
|Start Date ICMJE||October 29, 2001|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00025935 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Studies of Brain Function and Course of Illness in Pediatric Bipolar Disorder|
|Official Title ICMJE||Characterization and Pathophysiology of Severe Mood and Behavioral Dysregulation in Children and Youth|
|Brief Summary||This study seeks to learn more about the symptoms of severe mood dysregulation in children and adolescents ages 7-17. Children and adolescents with severe mood dysregulation (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). Researchers will describe the moods and behaviors of children with these symptoms and use specialized testing and brain imaging to learn about the brain changes associated with this disorder.|
The past decade has seen a dramatic increase in focus on pediatric bipolar disorder (BD), as the number of children receiving the diagnosis has escalated . Discussion has centered on the diagnostic boundaries of bipolar disorder, and whether nonepisodic severe irritability is a developmental presentation of mania. Beginning in 2002, our work defined a specific phenotype [severe mood dysregulation (SMD)] including youth with chronic angry mood with behavioral outbursts and hyperarousal symptoms. The purpose of this work has been to examine similarities and differences between youth with BD and SMD, and address the nosological question of whether the diagnosis of BD should be separated from a chronic angry mood with behavioral outbursts and hyperarousal symptoms similar to those present in children and adolescents with attention deficit hyperactivity disorder (ADHD). Before this work began, there was substantial debate, with little evidence to support either position.
Over the last decade, there has been substantial progress suggesting these might be best viewed a separate conditions, but important questions remain. In 2013 the Diagnostic and Statistical Manual (DSM) added Disruptive Mood Dysregulation Disorder, (DMDD) that is very similar to SMD in that it shares features of severe irritability. Future work needs to address the relationship between classic presentations of BD (as in protocol 00-M-0198) and SMD, as defined in this protocol or DMDD as defined in the DSM. Data suggest that there is a strong likelihood for those DMDD/SMD in youth to develop Major Depression. Thus, youth with Major Depressive Disorder (MDD) (with and without prior DMDD) are an important comparison group. We are examining the developmental trajectory, phenomenology, behavioral correlates, and underlying neural mechanisms of chronic irritability and MDD in youth. Our overall goal is to gain a clearer understanding of the course and neurophysiology these disorders to inform treatment and improve the outcome for children with irritability and depression. In order to advance this aim this protocol has 3 objectives:
B. Study population:
There are 4 separate populations being studied in this protocol:
For children and adolescents with SMD or full or subthreshold DMDD and/or MDD, this study is an outpatient characterization and longitudinal follow-along design. Once determined to be eligible, individuals come for an initial assessment, and then return at 1-2-year intervals until age 25 for clinical interviews, behavioral tasks, and structural and functional MRI.
For healthy volunteer children, adults and parents of healthy volunteer children, this study is an outpatient cross-sectional study that includes clinical interviews, behavioral tasks, and structural and functional MRI.
For all individuals, genetic material from saliva or blood is obtained under protocol 01-M-0254.
This study will examine between-group differences in clinical, behavioral, genetic, neuroanatomical, and neurophysiological variables in individuals with SMD or full or subthreshold DMDD and/or MDD, BD (BD, see protocol 00-M-0198), and healthy volunteers.
Children with SMD or full or subthreshold DMDD and/or MDD may also be compared on these features to those with other disorders (e.g. anxiety, depression) who are studied under Dr. Daniel Pine s protocol 01-M-0192 in order to elucidate differences between SMD or DMDD and these conditions.
Longitudinal clinical, behavioral, and neuroanatomical data will also be obtained.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||1350|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
(for patients with DMDD or subthreshold DMDD, 1 through 6 must be met; for those with SMD, we also add 7):
INCLUSION CRITERIA: CHILDREN WITH SMD OR DMDD ENTERING TREATMENT:
Those eligible for treatment must meet all criteria for DMDD or SMD; subthreshold DMDD is not eligible for treatment. In addition to criteria in 1 (above),
2.1. The child s current CGAS score less than or equal to 60.
2.2. The child s psychiatrist/treater agrees that the child s response to his/her current treatment makes it clinically appropriate to change the child s current treatment.
2.3. On the basis of record review and interviews with child and parent, the research team agrees that the child s response to his/her current treatment is no more than minimal (i.e. CGI-I>2).
EXCLUSION CRITERIA FOR THOSE WITH SMD OR DMDD:
INCLUSION CRITERIA: HEALTHY VOLUNTEER (CONTROL) INCLUSION CRITERIA:
EXCLUSION CRITERIA: HEALTHY VOLUNTEER:
INCLUSION CRITERIA: HEALTHY VOLUNTEER ADULTS:
EXCLUSION CRITERIA: HEALTHY VOLUNTEER ADULTS:
INCLUSION CRITERIA: Children with Major Depressive Disorder (MDD):
4.1. has no exclusionary criteria for MRI scanning
4.2. is failing his/her treatment as defined as:
4.2.1. The child s current CGAS score less than or equal to 60.
4.2.2. The child s psychiatrist/treater agrees that the child s response to his/her 4.2.3. current treatment makes it clinically appropriate to change the child s current treatment.
4.2.4. On the basis of record review and interviews with child and parent, the research team agrees that the child s response to his/her current treatment is no more than minimal (i.e. CGI-I>2).
EXCLUSION CRITERIA FOR THOSE WITH MDD:
|Ages||7 Years to 25 Years (Child, Adult)|
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00025935|
|Other Study ID Numbers ICMJE||020021
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||National Institute of Mental Health (NIMH)|
|Study Sponsor ICMJE||National Institute of Mental Health (NIMH)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||January 13, 2017|
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