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
Condition: Schizophrenia; Schizoaffective Disorder; Bipolar I Disorder; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome; Schizophrenia; Psychotic Disorders
Intervention: Aripiprazole; Oanzapine, risperidone, or quetiapine
Intervention description: Aripiprazole administered orally as tablets, 5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days within a range of 10 to 30 mg daily, for 16 weeks; Oanzapine, risperidone, or quetiapine administered orally as tablets at prior dosage for 16 weeks
Intervention MeSH terms: Risperidone; Aripiprazole; Quetiapine Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      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).
    

Eligibility criteria:

        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.