Status:
TERMINATED
Side Effect Study of Antipsychotic Medicines to Treat Childhood Bipolar Disorder
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Bipolar Disorder
Eligibility:
All Genders
7-12 years
Phase:
NA
Brief Summary
The purpose of this study is to learn more about weight gain and related side effects when children are treated with antipsychotic medicine for mood disorders.
Detailed Description
This protocol is a six month, randomized, open label trial of risperidone versus aripiprazole in antipsychotic naive youth (7 - 12 years old) who have been identified by their clinical treatment provi...
Eligibility Criteria
Inclusion
- We will include children, ages 7 - 12 years old, male and female with diagnosis of a bipolar spectrum disorder.
- Specific diagnoses included are as follows:
- Bipolar I disorder,
- Bipolar II disorder,
- Bipolar Disorder Not Otherwise Specified,
- Mood Disorder Not otherwise specified.
- The inclusion of a spectrum of bipolar diagnosis is because children with moderate to severe impairment from mood symptoms often still do not meet criteria for Bipolar I disorder since young children tend to have more chronic (non-episodic) course of symptoms and diagnostic criteria for Bipolar I disorder are more difficult to apply to adults than young children (e.g. symptoms of grandiosity and euphoria).
- No prior treatment with an antipsychotic medication for \>30 days. This criteria was added because weight loss on an assigned treatment may be due to discontinuing a prior antipsychotic medication rather than due to the current treatment.
- Recommendation from a current psychiatric treatment provider for treatment with an antipsychotic medication.
- This inclusion criteria provides an added layer of safety in that youth who have referred for the study have already been deemed by their independent provider to need an antipsychotic medication, so we are only exposing children to antipsychotic treatment who would have been treated with this type of medication regardless of whether or not there care was provided in a research or clinical program.
Exclusion
- Medications: We will exclude children who are on current treatment with
- oral steroids,
- lithium,
- depakote since these medications will have a confounding effect on weight.
- We will allow children on stimulant medication to participate, because ADHD comorbidity is very high in prepubertal bipolar disorder (unlike adolescent or adult onset bipolar disorder).
- We are including ADHD children to thus increase generalizability of the study, and it would be inappropriate to withhold stimulant treatment from these children for a six month period.
- Recruitment will be stratified to make sure there are equal numbers of patients on stimulants in each group.
- Somatic Conditions: We will exclude children with diabetes (type I or type II), and those with physical disability that would interfere with physical activity (will specifically exclude children whose guardian reports that the child has been medically excused from physical education at their school program because of physical disability) since insulin sensitivity and activity levels are outcome measures being assessed in this protocol.
- We will exclude youth with mental retardation, by parent report. Cognitive screening will be done with the Wechsler Abbreviated Scale of Intelligence (WASI).
- Youth with an IQ less than 70 will be excluded because they may have difficulty with self report measures.
- We will exclude children who have a history of treatment of an antipsychotic medication for \>30 days, as explained above.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00746252
Start Date
June 1 2008
End Date
October 1 2010
Last Update
January 6 2020
Active Locations (1)
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1
University of Maryland, School of Medicine, Department of Psychiatry, Division of Child and Adolescent Psychiatry
Baltimore, Maryland, United States, 21201