Reducing Weight Gain and Improving Metabolic Function in Children Being Treated With Antipsychotics

Summary

This study will test the effectiveness of two different treatments for children and adolescents who have gained weight on their antipsychotic medications.

Conditions

• Psychotic Disorders

Interventions

DRUG

Aripiprazole or Perphenazine

Baseline second generation antipsychotic (SGA) treatment will be gradually decreased and discontinued over 8 weeks while treatment with aripiprazole or perphenazine will be increased to effective levels.

DRUG

Metformin

Metformin treatment will be added to current SGA treatment, with dosing based on participant weight and increased according to a preset titration schedule unless side effects interfere.

DRUG

Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine

Current antipsychotic medication will be continued throughout the treatment period, with changes in dose only made as clinically indicated

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• University of Maryland

  collaborator OTHER

• University of North Carolina, Chapel Hill

  collaborator OTHER

• The Zucker Hillside Hospital

  collaborator OTHER

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Gloria Reeves, MD · University of Maryland

• Linmarie Sikich, MD · University of North Carolina, Division of Child and Adolescent Psychiatry

• Christoph Correll, MD · The Zucker Hillside Hospital

• Mark A. Riddle, MD · Johns Hopkins University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

8 Years

Max Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-01-31

Primary Completion

2014-03-31

Completion

2014-03-31

Countries

• United States

Study Locations