Side Effect Study of Antipsychotic Medicines to Treat Childhood Bipolar Disorder

NCT ID: NCT00746252

Last Updated: 2020-01-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2010-10-31

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.

Conditions

Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

1

risperidone

Group Type: EXPERIMENTAL

risperidone

Intervention Type: DRUG

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.

2

aripiprazole

Group Type: EXPERIMENTAL

aripiprazole

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Brand name: Risperdal; Brand name: Abilify

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Gloria Reeves

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gloria Reeves, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

University of Maryland, School of Medicine, Department of Psychiatry, Division of Child and Adolescent Psychiatry

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

HP-00043695

Identifier Type: -

Identifier Source: org_study_id