Improving Metabolic Parameters of Antipsychotic Child Treatment With Ziprasidone, Aripiprazole, and Clozapine

• Status: Terminated
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the relative risks and benefits of two approaches to the control of weight gain and other negative side effects in children and adolescents on 2nd generation antipsychotics (SGA):

• Healthy lifestyle instruction (nutritional and physical activity surveillance and advice) + continuation of current SGA;

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: Foundation of Hope, North Carolina
• Treatments: Antipsychotic Agents; Aripiprazole; Clozapine; Metformin; Ziprasidone

Criteria

Inclusion Criteria:

• Ages 10 to 17 years (inclusive).

• Receiving treatment with ziprasidone, aripiprazole or clozapine for the past 56 days or longer.

• Clinically stable on current treatment regimen (see Rationales below).

• Stable dose of current psychotropic co-medications for at least 30 days.

• BMI increase of > 7% within 3 months OR a > 0.5 BMI z-score increase within the past 24 months while taking olanzapine, quetiapine or risperidone, with maintenance of the threshold level of weight gain.

• Lifetime diagnosis of a schizophrenia spectrum disorder (schizophrenia, schizoaffective disorder, psychotic disorder NOS), a bipolar spectrum disorder (bipolar disorder, bipolar disorder NOS), certain mood disorders (mood disorder NOS, major depressive disorder with psychotic features), or certain disruptive/aggressive disorders (conduct disorder, intermittent explosive disorder, autism spectrum disorder with history of clinically significant levels of disruptive behaviors as defined below) using DSM-IV criteria determined by clinical interview and K-SADS-PL.

• Sexually active girls must agree to use an effective form of birth control or be abstinent.

• Principle caretaker is able to participate in study appointments as is clinically indicated.

• guardian and the child must agree (legally consent and assent) to participation.

Exclusion Criteria:

• Any medication that would significantly alter glucose, insulin or lipid levels. Prohibited medications will include, but are not limited to: insulin, steroids, topiramate, sibutramine, orlistat, metformin, amantadine, vitamin E (other than in standard multivitamins), antidiabetic drugs, HIV drugs.

• Major neurological disorder or medical illness that affects weight gain (e.g., unstable thyroid disease), requires a prohibited systemic medication or procedure (e.g., diabetes mellitus [insulin], chronic renal failure [steroids]) or that would prevent participation in physical activity in the healthy lifestyle program.

• Current active thyroid (TSH >18 microIU/ml), hepatic (2 LFTs >4x upper limits of normal), renal (serum Creatinine >1.4 mg/dL in females and serum Creatinine >1.5 mg/dL in males), cardiac, gastrointestinal, or adrenal disease.

• Fasting glucose > 125 mg/dL on two occasions indicating need for prompt treatment for diabetes.

• Child meets DSM-IV criteria for substance abuse or dependence disorder within the past month, not including tobacco abuse or dependence • Current treatment with more than one antipsychotic medication.

• Current treatment with more than 5 total psychotropic medications (i.e., 4 psychotropics plus SGA).

• Known hypersensitivity to metformin.

• Pregnant or breast feeding.

• Current or lifetime diagnosis of anorexia nervosa or bulimia nervosa.

• Significant risk for dangerousness to self or to others that makes participating inadvisable.

• Language issues that prevent child and/or parent from completing assessments or treatment.

• Ongoing or previously undisclosed child abuse requiring new department of social service intervention.