Side Effect Study of Antipsychotic Medicines to Treat Childhood Bipolar Disorder

NCT00746252 | Terminated Results DMC

• 1 other identifier: HP-00043695
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Keywords

bipolar; children; antipsychotic; side effect

Outcome Measures

Primary Outcomes (1)

• Weight Gain

  Weight gain from baseline to last observation up to 12 weeks. Last observation carried to 12 weeks.

  These measurements are done biweekly from baseline up until 12 weeks

Study Arms (2)

1

EXPERIMENTAL

risperidone

Drug: risperidone

2

EXPERIMENTAL

aripiprazole

Drug: aripiprazole

Interventions

risperidone 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.

Also known as: Brand name: Risperdal

1

aripiprazole 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.

Also known as: Brand name: Abilify

2

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

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

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Risperidone; Aripiprazole

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

The study funding stopped before a sufficient number of participants could be enrolled and therefore the study was terminated. Additionally the stopping criteria of 5% weight gain limited the length of time participants were in the study.

Results Point of Contact

• Title: Gloria M. Reeves, M.D.
• Organization: University of Marylland, Baltimore

greeves@psych.umaryland.edu

410-706-3522

Study Officials

• Gloria Reeves, M.D.

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 2, 2008
• First Posted: September 3, 2008
• Study Start: June 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: January 6, 2020
• Results First Posted: March 21, 2018

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)