Bipolar Disorder
Conditions
Keywords
bipolar, children, antipsychotic, side effect
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 provider as needing antipsychotic treatment of a bipolar disorder. This study proposes to monitor changes in metabolic parameters (body mass index percentile, % body fat, insulin resistance, and lipid levels) over the course of six months treatment with aripiprazole or risperidone in youth with a bipolar spectrum disorder. We will also assess possible mechanisms of second generation antipsychotic induced weight gain by monitoring physical activity and hunger/appetite changes over the course of treatment.
Interventions
DRUGrisperidone
Children will have a flexible dose titration based on their unique response to the medication (assessed using clinical global improvement scores). Children will be treated for six months using daily, bid dosing.
DRUGaripiprazole
children will have a flexible dosing titration based on their unique response (assessed using clinical global improvement scores). Children will be treated with daily medication for six months.
Sponsors
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Gain | These measurements are done biweekly from baseline up until 12 weeks | Weight gain from baseline to last observation up to 12 weeks. Last observation carried to 12 weeks. |
Countries
United States
Participant flow
Pre-assignment details
Two participants enrolled and completed baseline assessments but were withdrawn from the study at baseline due to the following reasons: 1. Abnormal glucose tolerance test requiring further assessment with endocrinology. 2. Unable to complete lab work due to increased distress.
Participants by arm
| Arm | Count |
|---|---|
| Risperidone risperidone
risperidone: Children will have a flexible dose titration based on their unique response to the medication (assessed using clinical global improvement scores). Children will be treated for six months using daily, bid dosing. | 1 |
| Aripiprazole aripiprazole
aripiprazole: children will have a flexible dosing titration based on their unique response (assessed using clinical global improvement scores). Children will be treated with daily medication for six months. | 2 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | weight gain >7.5 % | 1 | 2 |
Baseline characteristics
| Characteristic | Aripiprazole | Total | Risperidone |
|---|---|---|---|
| Age, Continuous | 12.5 years STANDARD_DEVIATION 0 | 10.9 years STANDARD_DEVIATION 2.78 | 7.75 years STANDARD_DEVIATION 0 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 2 participants | 3 participants | 1 participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 1 | 2 / 2 |
| serious Total, serious adverse events | 0 / 1 | 0 / 2 |
Outcome results
Primary
Weight Gain
Weight gain from baseline to last observation up to 12 weeks. Last observation carried to 12 weeks.
Time frame: These measurements are done biweekly from baseline up until 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Risperidone | Weight Gain | 8.5 pounds | — |
| Aripiprazole | Weight Gain | 6.65 pounds | Standard Deviation 1.48 |
Comparison: Comparison of mean weight gain between groups.p-value: 0.495t-test, 2 sided