Clinical trial NCT00857818 (phase 3, status: terminated)
Conditions: schizophrenia, schizoaffective disorder, bipolar i disorder, metabolic syndrome
ICD codes: F20.0, F20.1, F20.2, F20.3, F20.5, F20.89, F20.9, F25.9, F25.0, F25.1, F25.8, F31.70, F31.71, F31.72, F31.73, F31.74, F31.75, F31.76, E88.81
Drugs: aripiprazole, oanzapine, risperidone, or quetiapine
SMILES: ClC1=CC=CC(N2CCN(CCCCOC3=CC4=C(CCC(=O)N4)C=C3)CC2)=C1Cl, CC1=C(CCN2CCC(CC2)C2=NOC3=C2C=CC(F)=C3)C(=O)N2CCCCC2=N1
Reason stopped: 
    slow accrual
  
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.