Metabolic Effects of Antipsychotic Substitution in Children

NCT00910780 | Withdrawn Phase 2 DMC

• 1 other identifier: 08-0858
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Changes in per cent of body fat

  16 weeks

Secondary Outcomes (2)

• Changes in insulin sensitivity

  16 weeks

• Psychiatric safety and tolerability

  16 weeks

Study Arms (4)

Staying on Risperdal

ACTIVE COMPARATOR

Drug: Risperdal

Risperdal switched to Abilify

ACTIVE COMPARATOR

Drug: Aripiprazole

Staying on Zyprexa

ACTIVE COMPARATOR

Drug: Zyprexa

Zyprexa switched to Abilify

ACTIVE COMPARATOR

Drug: Aripiprazole

Interventions

Aripiprazole DRUG

via oral tablets, everyday

Risperdal switched to Abilify; Zyprexa switched to Abilify

Zyprexa DRUG

via oral tablets, taken once daily

Staying on Zyprexa

Risperdal DRUG

via oral tablets, taken once daily

Staying on Risperdal

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Pfizer: collaborator

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Aripiprazole; Olanzapine; Risperidone

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• John W Newcomer, MD

  Washington University School of Medicine and Florida Atlantic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2009
• First Posted: June 1, 2009
• Study Start: November 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: March 13, 2014

Record last verified: 2014-03