Status:
TERMINATED
Improving Metabolic Parameters of Antipsychotic Child Treatment With Ziprasidone, Aripiprazole, and Clozapine
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Foundation of Hope, North Carolina
Conditions:
Weight Gain
Eligibility:
All Genders
10-17 years
Phase:
PHASE2
Brief 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 a...
Detailed Description
The proposed pilot study is being conducted to obtain pilot data to support a grant application for a multi-site randomized controlled trial. The primary objective is to evaluate the relative risks an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00617058
Start Date
March 1 2007
End Date
September 1 2010
Last Update
December 31 2012
Active Locations (1)
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1
University of North Carolina, Department of Psychiatry
Chapel Hill, North Carolina, United States, 27599