Metabolic Effects of Antipsychotic Substitution in Children

NCT ID: NCT00910780

Last Updated: 2014-03-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2009-11-30

Brief Summary

This project aims to identify whether therapeutic substitution of aripiprazole for risperidone or olanzapine, combined with standard nutrition intervention, will impact the metabolic changes associated with antipsychotic treatment in children and adolescents.

Conditions

Diabetes

Study Design

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

Study Groups

Staying on Risperdal

Group Type: ACTIVE_COMPARATOR

Risperdal

Intervention Type: DRUG

via oral tablets, taken once daily

Risperdal switched to Abilify

Group Type: ACTIVE_COMPARATOR

Aripiprazole

Intervention Type: DRUG

via oral tablets, everyday

Staying on Zyprexa

Group Type: ACTIVE_COMPARATOR

Zyprexa

Intervention Type: DRUG

via oral tablets, taken once daily

Zyprexa switched to Abilify

Group Type: ACTIVE_COMPARATOR

Aripiprazole

Intervention Type: DRUG

via oral tablets, everyday

Interventions

Aripiprazole

via oral tablets, everyday

Intervention Type: DRUG

Zyprexa

via oral tablets, taken once daily

Intervention Type: DRUG

Risperdal

via oral tablets, taken once daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 6-18 years (at any point during study participation
• BMI > 85th percentile
• One or more DSM-IV diagnoses, including disruptive behavior disorders (attention deficit disorder, conduct disorder, oppositional defiant disorder and disruptive behavior disorder not otherwise specified), affective disorders (bipolar affective disorder, major depressive disorder and mood disorder not otherwise specified), anxiety disorders (generalized anxiety disorder, obsessive compulsive disorder, separation anxiety, social and other specific phobias) as well as other disorders, including autism spectrum disorders (autistic disorder, Asperger's Syndrome and pervasive developmental disorder not otherwise specified), psychotic disorders (schizophreniform disorder, schizophrenia and psychotic disorder not otherwise specified) and movement disorders (tic disorder, Tourette's Syndrome)
• At least 12 weeks of treatment and no more than approximately 12 months treatment with risperidone or olanzapine immediately prior to study enrollment (assuming that the initial phase of prior treatment involved a dose titration; clinically minor dosing deviations such as changes in dose or missed doses will be evaluated for inclusion by the PI on an individual basis)
• No clinically significant changes in permitted medications (e.g., stimulants) for 1 month prior to Baseline Evaluations (inclusion determined by evaluation on an individual basis by the PI)
• Clinically significant weight gain during an initial course of antipsychotic treatment; for non-MEAC participants, this is defined as > 10% increase from baseline weight during the prior treatment if treatment lasted approximately 5-12 months or defined as > 7% increase from baseline weight during the prior treatment if treatment lasted approximately 3-4 months (based on the totality of information from primary care provider, school and home); for prior MEAC participants, clinically significant weight gain is defined as > 7% increase from baseline weight over the course of the 3 month MEAC study and/or > 10% increase in total body fat as measured by DEXA during the MEAC study

Exclusion Criteria

• Active suicidality
• The presence of any serious medical disorder or condition that may, in the judgment of the PI, confound the assessment of relevant biologic measures or diagnoses, including: clinically significant organ system dysfunction; significant endocrine disease, including diabetes mellitus; coagulopathy; significant anemia; or significant acute infection; or pregnancy
• Participants taking within the last 3 months any glucose lowering agent, lipid lowering agent, exogenous testosterone, recombinant human growth hormone, or any other endocrine agent that might confound substrate metabolism, oral glucocorticoids (glucocorticoid nasal spray and inhalers are permitted), sedating antihistamines (non-sedating antihistamines like Claritin (loratadine) and Zyrtec (cetirizine) are permitted), non- serotonin selective reuptake inhibitor antidepressants and mood stabilizing agents (exposure to SSRI's, stimulants, clonidine and guanfacine permitted)
• IQ < 70 (based on school records and/or evaluation by clinician)
• Current substance abuse; vi) past history of, or current dyskinesia
• Stimulant dosage higher than approximately 2 mg/kg/day methylphenidate or equivalent dose of non-methylphenidate stimulant
• Participants who at baseline have elevated total cholesterol or low density lipoprotein cholesterol (> 95th percentile for age and gender) will be excluded based on recent American Academy of Pediatric recommendations to treat this level of dyslipidemia with pharmacotherapy,(63) unless is can be documented that they achieved the > 95th percentile dyslipidemia during antipsychotic treatment but did not have it at baseline (e.g., MEAC recruits) given the clinical equipoise around whether the planned intervention could lower lipids back below the threshold and allow them to avoid the risks of lipid lowering drugs
• Baseline fasting triglyceride > 400 mg/dl

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John W Newcomer, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine and Florida Atlantic University

Other Identifiers

08-0858

Identifier Type: -

Identifier Source: org_study_id