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

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Status and phase

Phase 3


Bipolar I Disorder
Schizoaffective Disorder
Metabolic Syndrome


Drug: Oanzapine, risperidone, or quetiapine
Drug: Aripiprazole

Study type


Funder types




Details and patient eligibility


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).


64 patients




18 to 65 years old


No Healthy Volunteers

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.

Trial design

Primary purpose




Interventional model

Parallel Assignment


None (Open label)

64 participants in 2 patient groups

Experimental group
Drug: Aripiprazole
Control group (Oanzapine, risperidone, or quetiapine)
Active Comparator group
Drug: Oanzapine, risperidone, or quetiapine

Trial contacts and locations



Data sourced from

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