Side Effect Study of Antipsychotic Medicines to Treat Childhood Bipolar Disorder (PAMS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gloria Reeves, University of Maryland
ClinicalTrials.gov Identifier:
NCT00746252
First received: September 2, 2008
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Bipolar Disorder
Drug: risperidone
Drug: aripiprazole

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Investigating Metabolic Side Effects of Antipsychotic Medications in Children

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Metabolic parameters [ Time Frame: These measurements will be done at baseline, 3 weeks, 3 months, six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • changes in physical activity (using an accelerometer monitor). [ Time Frame: These measurements will also be done at baseline, 3 weeks, 3 months, and six months over the course of treatment. ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
risperidone
Drug: 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.
Other Name: Brand name: Risperdal
Experimental: 2
aripiprazole
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.
Other Name: Brand name: Abilify

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.

  Eligibility

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746252

Locations
United States, Maryland
University of Maryland, School of Medicine, Department of Psychiatry, Division of Child and Adolescent Psychiatry
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Gloria Reeves, M.D. University of Maryland, Baltimore County
  More Information

No publications provided

Responsible Party: Gloria Reeves, Associate Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT00746252     History of Changes
Other Study ID Numbers: HP-00043695
Study First Received: September 2, 2008
Last Updated: June 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Maryland:
bipolar
children
antipsychotic
side effect

Additional relevant MeSH terms:
Bipolar Disorder
Disease
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes
Antipsychotic Agents
Aripiprazole
Risperidone
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 21, 2014