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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00746252
Recruitment Status : Terminated (Due low rate of participation and lack of funding)
First Posted : September 3, 2008
Results First Posted : March 21, 2018
Last Update Posted : March 21, 2018
Information provided by (Responsible Party):
Gloria Reeves, University of Maryland, College Park

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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: risperidone Drug: aripiprazole Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Investigating Metabolic Side Effects of Antipsychotic Medications in Children
Study Start Date : June 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Experimental: 1
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
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

Primary Outcome Measures :
  1. Weight Gain [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00746252

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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, College Park
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Principal Investigator: Gloria Reeves, M.D. University of Maryland, Baltimore

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Responsible Party: Gloria Reeves, Associate Professor, University of Maryland, College Park Identifier: NCT00746252     History of Changes
Other Study ID Numbers: HP-00043695
First Posted: September 3, 2008    Key Record Dates
Results First Posted: March 21, 2018
Last Update Posted: March 21, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Gloria Reeves, University of Maryland, College Park:
side effect

Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Antipsychotic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antidepressive Agents
Dopamine Agonists
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin 5-HT2 Receptor Antagonists
Dopamine D2 Receptor Antagonists