Improving Metabolic Parameters of Antipsychotic Child Treatment-Multi-site Study - “IMPACT-MS”

Focus of Study:

Weight gain on antipsychotic medication

Purpose:

This study will examine 3 different approaches (over 24 weeks) to control weight gain and other negative side effects in children and adolescents, ages 8-19, who have been taking an antipsychotic medication and gained a significant amount of weight:

· continuation of current SGA;

· Switch to aripiprazole (Abilify) or perphenazine (Trilafon) while stopping the current SGA;

· Add the diabetes drug, metformin + continuation of current SGA.

Subjects may be paid up to $375 to participate in and complete this study. Study medication (if prescribed) will be provided, outpatient psychiatric care from research staff will be free of charge, and transportation may be provided if needed.

Enrollment:

Primary Completion Date:

TBD

Ages of Eligibility:

8-19 years

Inclusion Criteria:

Between the ages of 8 and 19, male or female, any race or ethnicity
Diagnosis of Schizophrenia or Bipolar Spectrum Disorder or experiencing irritability
Currently taking olanzapine, quetiapine, risperidone, ziprasidone, or aripiprazole and currently stable on current treatment regimen
Have gained weight while taking one of these medications

Exclusion Criteria:

Known hypersensitivity to metformin
Current use of a medication known to decrease weight gain – amantidine, histamine (H2) antagonists (cimetidine, ranitidine, nizatidine), topiramate, orlistat, sibutramine, stimulants (dextroamphetamine, methylphenidate) or significantly alter glucose, insulin, or lipid levels (other than currently prescribed psychotropic medications)
Any current or past diagnosis of an eating disorder
Diabetes mellitus or current active thyroid, hepatic, renal, cardiac, gastrointestinal, or adrenal disease
Current substance abuse/dependence within past month
Pregnancy or breast feeding

Contacts:

Contact person: Cheryl Alderman

Phone: 1-800-708-0048

E-mail: ASPIRE@unc.edu

Locations:

UNC outpatient/UNC inpatient and CTRC

Sponsors & Collaborators:

NIMH

Investigators:

Linmarie Sikich, MD