Trial Comparing the Effects of Aripiprazole With Those of Standard of Care on Non-HDL Cholesterol in Patients With Schizophrenia or Bipolar I Disorder Who Have Metabolic Syndrome

A 16-Week, Randomized, Controlled Trial of the Effect of Aripiprazole Versus Standard of Care on Non-HDL Cholesterol Among Patients With Schizophrenia and Bipolar I Disorder Who Have Pre-existing Metabolic Syndrome

The purpose of this study was to determine whether patients with schizophrenia, schizoaffective disorder, or bipolar I disorder who also have metabolic syndrome have a larger decrease in fasting non-high density lipoprotein (non-HDL) cholesterol levels with aripiprazole than with their current atypical antipsychotic treatment (olanzapine, risperidone, or quetiapine).

Inclusion Criteria:

• Competency in understanding nature of study and ability to sign informed consent form
• A clinical diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder (manic or mixed) that has been treated with antipsychotics (oral olanzapine, risperidone or quetiapine) for at least 3 months.
• Treatment with any of the antipsychotic medications olanzapine, risperidone, or quetiapine for at least 3 months
• A Clinical Global Impression-Severity Scale score of 4 or lower at baseline
• Confirmed diagnosis of metabolic syndrome
• Patients not receiving treatment specifically for any of the parameters related to metabolic syndrome at the time of randomization
• Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and up to 4 weeks after last dose of investigational product
• Patients for whom it is clinically appropriate to switch from their current atypical antipsychotic to aripiprazole (determined by the investigator)

Exclusion Criteria:

• Risk of suicide (suicidal ideation or recently attempted suicide)
• Meeting Diagnostic and Statistical Manual of Mental Disorders, 4th ed, text revision criteria for any significant psychoactive substance use disorder within 3 months of screening
• Diagnosis of type 1 or 2 diabetes mellitus
• Current treatment for 1 of the components of metabolic syndrome
• Use of medication for the purpose of weight loss
• Diagnosis of bipolar disorders other than bipolar 1, depression with psychotic symptoms, or organic brain syndromes
• History of neuroleptic malignant syndrome
• Diagnosis of Parkinson's disease, Alzheimer's disease, multiple sclerosis, cerebral palsy, epilepsy, or mental retardation
• History of seizures
• Abnormal blood count for platelets, hemoglobin, absolute neutrophils, aspartate aminotransferase, alanine aminotransferase, creatinine, fasting glucose, and thyroid-stimulating hormone
• Electrocardiogram recording with QTc interval >475 msec
• Detectable levels of cocaine or positive screen for stimulants or other drugs considered (determined by the investigator) to be of abuse or dependence
• Blood alcohol levels superior or equal to 50 mg/dL [or 10.9 mmol/L]
• Prior participation in an aripiprazole clinical trial
• Treatment with aripiprazole within 1 month of enrollment
• Predefined exclusionary laboratory tests
• Patients with Bipolar Disorder treated with adjunctive therapy other than a stable dose of mood stabilizers (lithium or valproate) must undergo a 30-day washout period for adjunctive therapies, such as antidepressants, prior to randomization.